Artificial Nanoparticle Blood Instant Oxygen Boost Report Assignment Sample

Question:

Prepare a basic business model for Artificial Nanoparticle Blood – Instant Oxygen Boost

Answer

Introduction

The research discusses the Artificial Nanoparticle Blood-Instant Oxygen Boost, which uses nanoparticles to control the hemoglobin’s oxygenation while allowing for the logical design of oxygen carriers based on hemoglobin. The oxygenation properties of adult human hemoglobin and sickle cell hemoglobin, which are linked to an increased oxygen affinity, are retained during the adoption process. The hemoglobin tetramers are adsorbed on the surface due to the hemoglobin's strong affinity for nanoparticles (Andocs et al., 2015). As a result of the interaction between nanoparticles and hemoglobin at the molecular level and its effect on the qualities defined for the oxygenation process that are precisely regulated, the development of bio-nanotechnology opens the door for the construction of blog replacements.

Value Proposition and Customer Segment

The customer segment is based on comprehending the needs of patients with problems, which can be separated into infectious and non-infectious concerns. This study shows that different users are used in different ways by all users, including interested parties, investors, consumers, analysts, reviewers, and suppliers. Stakeholders are connected to a number of suggestions and proposals for enhancing the auditors' report. They recognize concepts and strategies that could be vastly dissimilar from those of auditors and strengthen control over financial statements (Gy et al., 2015). It is common for all users to gain from an analyst's effort to forecast future sales, which usually indicates that other users, particularly those taking part in the evaluation, are also included. Accounting analysis is a typical account since it appears on the balance sheet; it is a real account with a recurring revenue stream. Controlling the exceptional preservation of the qualities of human adult and sickle cell hemoglobin depends on understanding the molecular interactions between nanoparticles and hemoglobin as well as their impact on the oxygenation properties. These real accounts are therefore likely to be balances that should have been erased over time without proper accounting investigation. It is possible to create an accounting examination of nominal accounts that includes a profit and loss account or with the help of biology dissertation help online. Accounting analysis is connected to financial statements that assess an organization's capacity to fulfil its obligations to recipients and other third parties as well as its capacity to boost revenue (Jamshidi t al, 2015). Understanding configuration patterns with financial data that have been established to work with various data partition formats is crucial for performing proper data analysis. In this situation, the corporation should concentrate on securing the benefits of creditors or investors in order to acquire various vital assets.

Key Partners / Stakeholders

As a result, the financial condition of the Organization in relation to its competitors is taken into account in the study of the business plan.

Since financial statements satisfy all customer needs, the company has several users of them (Zeng et al., 2016). With the rise of HIV, which is mostly caused by the issue of blood transfusions that tend to impose greater expenses at the time of detection tests, fake blood is brought to light. The less plentiful blood is primarily used in poorer nations. The study is about the increase in the product's half-life due to the reduction of phagocytosis, and the enzymes are contained in Nano capsules with a membrane constructed of ultrathin polyethylene glycol acid. In order to generate nanoparticles and cell-like things that can usefully be able to improve the primary functions of red blood cells, various macroscopic selection that is decided by the endeavor to create good open access reviews must be managed. The difficulties are caused by changes in the blood's and the oxygen transport system's capacity (Hafsi et al., 2017).

The widespread synthesis of cells or entities that resemble cells is included in this conduct of oxygen-bearing nanoparticles. Users of the company's financial reports include:

• Investors: As they are owners of the company and are required to understand how financial resources are used, investors must be aware of the financial facts precisely (Kiransan et al., 2015).

• Management: In order to determine the company's functional and financial results, management must calculate the company's profit and cash flows on a monthly basis.

• Creditors: Lenders are interested in the cash flow and the minimal institution. They could receive loans from the business. Companies that are unable to repay loans put creditors at risk.

• Owners: Owners are typically the most significant customers and are interested in financial reporting. However, owners are also interested in profit and a fund where they must get a certain income and can participate. in the income statement's definition. Owners desire to know how much capital the business has used up so they can profit from sales (Ghaedi et al., 2015).

Key Activities and Resources

The financial situation of the company serves as the primary informational source in financial analysis. This information is required for the financial researcher's purposes. It is related to financial reporting since it organizes the assessment of the company's competitive work and determines the planning and operational effectiveness of the business (Dzamukova et al., 2015). The performance of the company can be determined and standardized with the aid of financial analysis. We will also take into account how this may affect the analytical techniques used to analyses financial data. A balance sheet is used in financial analysis, which mainly serves to record changes and support the study of various obligations and capital. Double accounting and the application of generally recognized accounting rules define financial characteristics. Deliveries in this situation are dependent on liabilities with financial responsibilities, and they subsequently transfer other assets to offer effective services. Commitments rely on a crucial necessity to match the company's diverse assets. The share capital and net assets, which are calculated for management and participation in the share capital, are merged for long-term employers. Work to keep the profits that the company is currently making by reinvesting them back into the company. These templates are based on payments made to the business's owners, in which the parties concerned and profits also govern the amount of retained earnings. The application is based on the shareholders' dividend payments, which may coincide with an offer of a certain amount of money.

Customer Relationships and Channels 

The fundamental issue is that CRM places a lot of emphasis on knowledge and various geographic boundaries. The situation is regarded as vital and as being in conflict with the circumstance. Social philosophers hold the views that are typically sought after by those and others who view themselves as distinct from the natural sciences. Real-world lifestyles are based on observations made by people with an interest in them. Here, divers prepare for various scenarios, and special factors serve to ascertain the public's overall understanding by a particular study. His study of corporate governance takes a pro-active stance in the pursuit of cause-and-effect relationships that establish system norms, objectives, and hypothesis tests. In order for the nanoparticles to carry more oxygen and eventually reach the body's tissues, it is critical to assess their engineering. Here, the treatment is determined by the injuries and whether the best oxygen-carrying nanoparticles are deemed secure over the long term.

Cost Structure and Revenue Stream

One of the financial statements' drawbacks is its reliance on historical costs when analyzing the balance sheet's various activities and asset and liability values. They frequently vary along with marketable securities, which are primarily modified to reflect shifts in marketing values. Concerns exist over the division's handling of unrecorded intangible assets in relation to the division's products, services, clients, and customers. The rule is to manage the commercial value and focus on a certain time period strategy.

In cases where the cash flow of the company is best understood by carefully examining one of the reporting periods, the use of financial statements can result in an inaccurate interpretation of the financial results. The management team's exposure to fraud activities while working with skew outcomes could result in a situation where other good results are exposed to undue pressure when it comes to bonus plan payouts. The management of business operations and the development of system standards with non-verification methods that are connected to measuring the issuer's policies, practices, and controls have not been discussed. The data must be set with the financial statement that offers the forms for system processing and the various variable costs that must be efficiently managed.

Revenue Streams

These are the sources of income, or revenue streams. Here, you should emphasize any potential sources of funding for the project:

• Insufficient Information: The financial statements are primarily used to determine the reporting period. As a result, there is a great chance of spotting inaccurate information. As a result, when the firm has ended, it is possible to determine the precise financial situation and the precise capacity of the organization's funds.

• Unlimited Information: To prepare financial accounts, accounting principles, practises, and conferences are used. Recruitment participation is also put to use for training. These outcomes are closely related to the financial accounts' correctness.

• The quality of information is neglected: The term "financial conditions" only refers to quantitative data, which is only included in financial reports. Quality facts, such as manager effectiveness, company generosity, employee-owner relationships, employee ability, and employee happiness, are completely ignored and are not referred to as financial terms. Therefore, in order to take a real financial condition and produce commercial results, these abilities are required.

• Incorrect disclosure of financial position: The company's financial status will be impacted by a number of factors, including commercial, state, and public finance, but only the financial part is taken into account in financial reporting. The financial statements do not include any commercial or general components. The company's financial status is disclosed as a result of this kind of routine practice.

• Financial statements are not specific: Financial reporting is not identified because numerous accounting methods are accessible to numerous organizations, accounting rules and regulations change, and the business capabilities of the companies vary from one another. Financial firms are unable to distinguish themselves as a result.

• The actual profit is not disclosed in the income statement: Operating and non-operating expenses are recorded in the income statement; the actual profit is not reported there. Only the assessment is presented; actual costs are not. The likelihood of withholding the true profit at the expense of profit and loss is then very high.

Conclusion

The company's interest is in better financial information management, particularly to draw in people and innovators who have debt with an interest rate. The interaction between Nano particles and haemoglobin at a specific level has been one of the other draws for the haemoglobin-based oxygen carriers. The primary purpose of using nanoparticles is to modify structural particles while releasing free haemoglobin into the bloodstream.

References

The following sources are cited: Andocs, G., Rehman, M.U., Zhao, Q.L., Papp, E., Kondo, T., and Szasz, 2015. Part II of nanoheating without synthetic nanoparticles. Utilizing an experiment with the U937 cell suspension model, the modulated electro-hyperthermia method provides support for the nanoheating notion. 7(4), page 1 of Biology and Medicine.

2015 study by M.R. Dzamukova, E.A. Naumenko, E.V. Rozhina, A.A. Trifonov, and R.F. Magnetic nanoparticles supported by polyelectrolytes are a simple method for creating artificial multicellular tissue-like clusters for cell surface engineering. Pages. 2515-2532 in Nano Research, 8(8).

2015. Artificial neural network-based genetic algorithm based optimization for the adsorption of phenol red (PR) onto gold and titanium dioxide nanoparticles loaded on activated carbon. Ghaedi, M., Daneshfar, A., Ahmadi, A., and Momeni, M.S. 21, pp. 587–598 in Journal of Industrial and Engineering Chemistry.

(2015). Gy, V., Szigeti, G.P., Andocs, and Szasz without the use of synthetic nanoparticles, nanoheating The following authors published a paper in 2017: Hafsi, B., Boubaker, A., Guerin, S. Lenfant, S. Desbief, F. Alibart, A. Kalboussi, D. Vuillaume, and K. Lmimouni. Artificial synapse using electron-transport polymeric gold nanoparticles for neuromorphic applications. 499–506 in Organic Electronics, 50.

The following authors published a paper in 2017: Hafsi, B., Boubaker, A., Guerin, S. Lenfant, S. Desbief, F. Alibart, A. Kalboussi, D. Vuillaume, and K. Lmimouni. Artificial synapse using electron-transport polymeric gold nanoparticles for neuromorphic applications. 499–506 in Organic Electronics, 50.

Karaca, S., Sheydaei, M., Khataee, A., and Kranan, 2015. ZnO nanoparticles produced on montmorillonite are used in the photocatalytic removal of a dispersion dye in artificial neural network modelling. Molecular and Biomolecular Spectroscopy, 140, pp. 465–473, Spectrochimica Acta Part A.

A 2016 study by Zeng, H.H., Qiu, W.B., Zhang, L., Liang, R.P., and Qiu, J.D. Lanthanide coordination polymer nanoparticles serve as a superior synthetic peroxidase for the detection of hydrogen peroxide. Pages 6342–6348 of Analytical Chemistry, 88(12).

Question

Task: Prepare a report on the topic 'Fluid mosaic model of membrane structure'.

Answer

Introduction

A cell membrane with the property of being a two-dimensional liquid with mixed composition is referred to as a fluid mosaic model. The hydrophobic components that are incorporated into the development of the membrane give the cell membrane its fluid quality and cause the lipids and proteins to migrate from one side of the membrane to the other. The membrane has a nature that is more fluid. The fluid mosaic model uses the term "mosaic" to describe anything that was created by combining many elements, which explains why it is appropriate for this model of biology assignment. The fact that the cell membrane is made up of several components justifies the use of the word mosaic in the model's name, the fluid mosaic model. The fluid quality of the cell membrane is caused by the presence of phospholipids, which do not form bonds with one another. The phospholipid molecules have a head that is drawn to water, causing it to point in the direction of the cell membrane's outer surface and giving it a hydrophilic quality. There are two directions that the molecules move in. The tail aids in removing the water that forms a bilayer to create non-polar hydrophobia by wading it away. Fatty acids make up the phospholipid tail, which is continually moving. After the creation of the fluid mosaic model, the development of the bilayer became known. The process is weaker since each person goes through it alone (Catala, 2012). The production of cholesterol is one of the many proteins and chemicals that are entrenched in the bilayer. The plasma membrane has a consistency similar to that of vegetable oil that has been put at room temperature, which allows proteins and several other things to travel around it. Understanding the plasma membrane is accomplished using the fluid mosaic model. The cell membrane is made up of several substances, each serving a specific function. The membrane is stabilized by the cholesterol that becomes embedded in its bilayer, preventing it from hardening at lower body temperatures. The plasma membrane of the cells found in animals is also better understood using the fluid mosaic concept. Glycoproteins and glycolipids are formed from the carbohydrate chains that make up the cell membrane's outer layer. The way that carbs are formed varies from person to person, and how they are formed relies on the type of blood that each individual has (Leabu, 2013).

How did Fluid Mosaic Model Come into Existence?

To explain the composition of the plasma membrane, S.J. Singer and G. L. Nicolson developed the fluid mosaic model. It was believed to be a fundamental component of cell membranes that would aid in future research by explaining the information already available regarding the proteins and lipids found in the membrane (Nicolson, 2016). Even though the concept has changed over time, it is still regarded as a valid theory for explaining the nano-structures of many intracellular and cellular membranes seen in the cells of both plants and animals. The arrangement of the particles in the cell membrane is depicted by the fluid mosaic model. Meanwhile, new information about lipid rafts, proteins, and glycoproteins emerged, aiding in the description of the membrane's structure. Due to the ideas mentioned to define the Fluid Mosaic Model, new information about the cell membrane came to light. The mosaic character is given more weight in recent information (Nicolson, 2016).

What are the different organelles of a cell?

The term "cell organelles" refers to various cellular elements present in both plants and mammals. Organelles are the various structures that make up a cell. The membrane that surrounds the cell's organelles has a specific structure and function (Morange, 2013). All of a cell's parts are contained by the cell membrane, which also shields it from the environment. It also facilitates the entry and exit of ion-regulating particles from the cell. The coordination of these cell organelles is necessary for the cell to function normally. The following list of cell organelles has been discussed:

• Endoplasmic Reticulum:

This is a collection of membrane canals that is hydrated. They are viewed as a means of transportation that aids in moving materials inside the cell. A component of the endomembrane system that extends the nuclear envelope is the endoplasmic reticulum. Rough Endoplasmic Reticulum and Smooth Endoplasmic Reticulum are the two forms of the endoplasmic reticulum. Tubules, vesicles, and cisternae make up the rough endoplasmic reticulum. They aid in the synthesis of proteins and are present throughout the cell. An area of the smooth endoplasmic reticulum serves as storage. It aids in the synthesis of lipids and steroids. It also aids in cell detoxification. The Rough Endoplasmic Reticulum has several ribosomes linked to it, which results in an uneven structure and justifies the name of the organelle. The rough endoplasmic reticulum aids in the synthesis of proteins that leave the cell. These proteins are moved to the lumen inside the endoplasmic reticulum, where they undergo extensive shape modification. The Smooth Endoplasmic Reticulum receives the protein through the lumen and processes it further there. The absence of ribosomes in the Smooth Endoplasmic Reticulum contributes to its smooth structure. Due to a lack of ribosomes, it is unable to produce proteins. Making lipids and enzymes is the Smooth Endoplasmic Reticulum's primary job.

Functions of the Endoplasmic Reticulum:

• Produces and secretes steroid hormones

• Assists in the synthesis of lipids such as cholesterol and phospholipid

• Assists in the metabolism of carbohydrates

• Assists in the release of calcium ions, which is crucial for the nervous and muscular systems

• Ribosomes: This structure is where protein synthesis occurs, producing protein and ensuring the survival of living cells. It is made up of several molecules. All cell types, including prokaryotic and eukaryotic cells, have ribosomes. Ribosomes are required by every single cell for the production of proteins. The tiny and big subunits of the ribosomes are comprised of ribosomal RNA and ribosomal proteins. The messenger RNA (mRNA) and the amino acids that are associated with the transfer RNAs (tRNAs) are transported toward the ribosome during the synthesis of proteins. Proteins are made with the aid of amino acids. The Rough Endoplasmic Reticulum is where the ribosomes are affixed. They are floating in the cytoplasm and are unbound. They have no membranes and are quite tiny in size. Two-thirds of ribonucleic acid and one-third of protein make up this substance. They are also known as prokaryotic 70s or eukaryotic 80s, depending on the type of cell they are found in. S stands for size and density. The skin, hair, eyes, and face all contain ribosomes.

Functions of Ribosomes:

• Assembles amino acids to make proteins, which are thought to be a necessary component for a cell to function. Messenger RNA (mRNA) aids in protein synthesis with the support of the nucleus and cytoplasm.

• The messenger RNA (mRNA) polymers are encircled by ribosome subunits in the cytoplasm.

• The proteins are transported outside of the cell by the newly created ribosomes.

• Golgi Apparatus: Both plant and animal cells have the Golgi complex or the Golgi apparatus in their cytoplasm. It is an organelle that resembles a flat, layered sac that changes proteins and aids in their packaging. It consists of a group of membranes that closely collaborates with the endoplasmic reticulum to change proteins and carbohydrates. It typically has 6 cisternae but can have up to 20 in total. Cells of eukaryotic organisms have the Golgi apparatus. It is surrounded by a membrane, the size of which varies between locations. It actively participates in the production, storage, and delivery of goods made by the endoplasmic reticulum. The Golgi apparatus has a pancake-like form due to the folded membranes there. It serves as the home for numerous vesicles that the Smooth Endoplasmic Reticulum produces. Before being circulated throughout the cell, the Endoplasmic Reticulum's produced proteins are processed by the Golgi apparatus. The protein enters the Golgi apparatus from one side and exits from the opposite side toward the cell's plasma membrane with the assistance of the endoplasmic reticulum. One of the recognized models of the plasma membrane is the fluid mosaic model. A cell's Golgi body might vary depending on what it does.

Source: ( Mandira and Kate, 2017) ( Mandira and Kate, 2017)

The Golgi complex has the following functions:

• Absorbing compounds, assisting in secretion, and forming secretory vesicles
• Assisting in the formation of enzymes
• Assisting in the production of hormones
• Assisting in the storage of proteins
• Assisting in the formation of acrosomes
• Assisting in the formation of intracellular crystals
• Assisting in the formation of milk protein droplets
• Assisting in the formation of plant cell walls
• Assisting in the secretion of glycoprotein
• Lysosomes: Enzyme sacs are what are typically referred to as lysosomes. It aids in the digestion of the various lipids and nucleic acids found in a cell. The lysosomes' internal environment has an acidic character. The circumstances found in the lysosome membrane offer the enzymes a favourable environment in which to work. The cytoplasm is where they are located. The lysosome aids in the breakdown of dying cells, organelles, poisons, and food particles. Lysosomes are frequently referred to as suicide sacks. The lysosome buds from the Golgi complex's membrane sacs. One of the functions of lysosomes is to act as a container for the removal of waste ( Pu, Guardia, Keren-Kaplan and Bonifacino, 2016). Both the prevention and the aetiology of various diseases may be affected by the chemicals that process lysosomes.

Source: (Fields, n.d)

Functions of lysosomes:

• Aid in intracellular digestion
• Remove dead cells
• Aid in metamorphosis
• Aid in protein synthesis
• Aid in fertilization
• Aid in the process of ontogenesis
• Aid in the removal of toxins
• Aid in the digestion of food particles
• Aid in the formation of bone cells

What is Kartagener Syndrome, and How is it Caused?

Source: (Plessis and Wahba, (n.d))

A person who has acute sinusitis, bronchiectasis, and situs inverse is said to have Kartagener syndrome. Kartagener syndrome is caused by the improper acquisition of the motor protein dynein. Chest infections and infertility result from the cilia moving improperly (Xu, Gong and Wen, 2017). Biofilms gathered from the air are incorporated into the mucus, causing bacterial infections and tissue damage. Kartagener syndrome-affected males may generate sterile sperms, and they can only become fathers with the assistance of a physician who can inject the sperm cells into the eggs. When there is a genetic flaw, Kartagener syndrome results. When both parents have the illness and pass the syndrome on to their children, it happens.

What is the role of abnormal dynein in causing the syndrome? How it alters the flagella? How it leads to the building of mucus in the airway?

Genetic disease is the cause of Kartagener syndrome. It results from the production of protein dyneins. People who contract the illness experience chronic sinusitis and mucus buildup in the lungs' airways. The development of germs in the mucus is a possibility. If the condition is inherited, it may develop severe bronchiectasis in children or adults, which can lead to respiratory failure. Cilia and flagella, which are affixed to the surface of eukaryotic cells, are also impacted by the illness. The mucus is moved by the cilia, which also aids in clearing the airways of foreign objects. When the cilia are not functioning properly, it can cause respiratory system problems and make breathing more difficult.

How does Kartagener Syndrome Cause Infertility?

Males with Kartagener syndrome may generate sperm that is sterile. Despite normal sperm production, dynein flagella are absent or have shrunk, which has an impact on sperm quality. The best course of action in these circumstances is to visit a physician who can assist the men in becoming fathers by injecting the eggs with their sperm cells.

The Fluid Mosaic Model, its history, and its etymology have all been covered in the current study. The article also includes information on several cell organelles and a mention of Kartagener syndrome.

Reference List

Microbiological Contamination Assignment: Discussion on Remediation

Question

Task: The assignment is designed to evaluate how well you research, and apply contamination control strategies and remediation.
There is no word limit to this assignment.
The assignment is worth 20% of the subject marks.
All assignment work must be the individuals.

Note:

A) The work must be your own and should include a bibliography of source material. Penalties will apply if students submit the same paper.

B) Useful information on preparing assignments is available in the

External Links folder for this subject.

C) All assignments should be uploaded to Turnitin on the submission date specified in your student notes. An assignment cover sheet must be completed and attached to the front of the submitted assignment.

Cover sheets can be found at UTSOnline. You must retain a copy of your submitted work.

Contamination Control Remediation

The attached document is an FDA warning letter related to product contamination that was sent to a pharmaceutical manufacturer.

Your assignment is to examine the warning letter and:

1. Identify the type of contamination detected.

2. Identify the source of contamination

3. Identify the route of transmission

4. Propose practical procedures that would ensure that this type of contamination did not occur again. Categorise these procedures as prevention or detection strategies.

5. Prepare a response to the FDA detailing the corrective action necessary to address all the findings detailed in the Warning Letter.

Answer

Type of Contamination

Microbiological contamination induced by Bacillusthuringiensis or Acinetobacterradioresistens is the sort of contamination that is investigated in the microbiological contamination assignment (Ahmed, 2016).

Source

According to the research done for this biology assignment sample, the creation of foreign proteins and molecules of low molecular weight by the microorganisms Bacillus thuringiensis or Acinetobacter radioresistens is thought to be the source of microbiological contamination. The proteins generated by Bacillus thuringiensis are thought to pose a risk when used as an inexpensive pesticide formulation (purged and at high exposures) or when taken orally in extremely high doses. When administered parenterally in large doses, the decontaminated natural endotoxin that was let loose from these kinds of microorganisms was linked to risk. When an invulnerable traded off individual got infected by the complete, live form of the bacterium, Acinetobacter radioresistens may have been an opportunistic disease (Catellani et al., 2014).

Route of Transmission

The microbiological contamination assignment indicated a pathway of transmission that is anticipated to involve either a small number of bacteria already existing in the system or bacteria that were added during the production process, causing the small inoculum to increase. Non-host cell by-products produced by or as a result of defective high-high limit switches are among the additional channels of transmission (Croughan, Delfosse and Svay, 2014).

What are the practical procedures for the case scenario of microbiological contamination assignment?

Prevention Methods:

1. Risk assessment: This should involve a review of the established facts regarding processing times, in-process endotoxin results, mass drug substance bioburden, the composition of the drug substance as determined by testing, and the system of decontamination processes used during the assembling process.

2. According to the readings used to create this microbiological contamination assignment, crop risk assessments to reflect the greater groups of bacillus thuringiensis to protect drugs from its contamination (Croughan, Delfosse and Svay, 2014).

3. Additional risk assessment via estimation of the quantity and clearance of any potential contamination, toxicological assessment, and data analysis of unfavourable event.

4. Bioreactor disinfection

5. A choice To satisfactorily and successfully remove the filth created by the disinfecting technique under examination, a CIP cycle should be devised and examined.

Detection Techniques

1. Widespread drug substance discharge, stability, and irregular depiction testing

2. Potential impurity level and clearance should be established, toxicological evaluation of identified contaminations should be completed, and adverse event data for the lot should be evaluated.

3. Comparing Soliris drug material batches should undergo explicit investigative testing beyond normal discharge and stability to determine whether any potential pollutions were eliminated throughout the decontamination process.
Investigation of Bioreactor Contamination 4.

5. Additional surface sites should be included for investigative reasons to further develop the ability to identify potential sources of Bacillus thuringiensis and other spore-formers, as specified in the microbiological contamination assignment (Dancer, 2016).

Response Letter

Mr. Leonard Bell,
M.D. Chief Executive
Officer Alexion Pharmaceuticals, Inc.
352 Knotter Drive
Cheshire, CT 06410
March 27, 2013

Amber G. Wardell,
Director of Compliance,
New England District,
Food and Drug Administration,
One Montvale Avenue,
4th Floor, Stoneham,
Massachusetts 02180.

Telephone - 781-***-**84

Subject: Response to FDA Warning Letter- March 22, 2013

Dear Ms. Wardell:

Between July 12, 16-18, 20, 24-26, and August 6, 2012, a CGMP inspection was conducted at Alexion Pharmaceuticals, Inc., which has offices at 352 Knotter Drive in Cheshire, Connecticut, and 100 Technology Way in Smithfield, Rhode Island. Following the conclusion of the inspection on August 6, 2012, an FDA warning letter with Form "483" was delivered along with a number of observations. Alexion Pharmaceuticals, Inc.'s primary goal is to produce products that are both healthy and safe, despite its efforts to maintain order in numerous sectors. The representatives of our company are making an effort to maintain consistency in their work so that they can swiftly examine and modify the tactics and separate the proof and application of office improvements. We endeavoured to take decisive action to eliminate the associated risks at the time when the warning letter was issued, taking the investigators' assertions of perceptions seriously. In addition to trying to take a more thorough look at each component of our organisation, we have tried not to limit ourselves to only the viewpoints expressed in CMS #352798.

The Observations of GMP violations according to FDA's Inspection

If it's not too much of an issue, note that Alexion Pharmaceuticals, Inc. has had systems and tasks which address such observations accordingly for well over a year. These observations were specifically noted in the March 22, 2013 warning letter provided in this microbiological contamination assignment. All of Alexion Pharmaceuticals, Inc.'s cGMP products are subject to certain procedures and tasks, which are as follows:

1. The key deviations and a batch's inability to meet the specifics and the applicable quality requirements were not investigated by your company.
Response

The microbiological contamination assignment's risk assessments make the assumption that the threat to product quality was minimal. The data collected in accordance with SOP QC-0394 and further testing done include:

1. Acinetobacter radioresistens and Bacillus thuringiensis are not thought of as typical human infections (Dancer, 2016).

2. No impact on materials or preparation tools based on the outcomes of the daily practise in-process tests. Bioburden and endotoxin characteristics were all as low as possible:

• The post-filtered bioburden result was 0 CFU/10mL (announced as 1CFU/10 mL) (Shintani, 2015).

• Each of the pre-bioburden testing's results was 0 CFU/10mL (explained as 1CFU/10 mL) (Shintani, 2015).

• The endotoxin findings for all of the pre-tests were 1.25 EU/mL, which, in this case, is the limit of quantification (Shintani, 2015).

• The results for the bioburden and endotoxin were accounted for as 1CFU/10 mL and 0.0625 EU/mL, respectively, which is the highest level of quantification for this case (Shintani, 2015).

• The final mass product substance yields met determinations with aftereffects of 0 CFU/10 mL and 0.1 EU/mg, which serves as the threshold of quantitation in this example (Shintani, 2015).

1. According to the research conducted for the microbiological contamination assignment, the company is focused on finishing the expository tests for the drug material component by April 1, 2013. There were no unexpected results that suggested the presence of bacterial pollutants nearby. The results were expected, and those of the parcels that didn't experience the diagnostic advance had different results.

2. The risk assessments also showed that there was a minimal likelihood of the medicine being co-sanitized with distant proteins or low atomic weight particles that could be given by Bacillus thuringiensis or Acinetobacter radioresistens (Maillard, Sattar and Bradley, 2016).
Further Assessment of Risk

Apart from the elements analysed in SOP QC-0394 and the additional testing discussed above, it was also determined the amount and clearance of probable impurities, completed toxicological evaluations of identified polluting influences, and evaluated data on antagonistic events for the lot.
Worst Case Calculations:

• The calculations for the worst-case scenario, which were covered in the microbiological contamination assignment, were done to determine the quantity of potential impurities that may be produced and the freedom of the potential contaminating influences. in order to initially set up an examination of suspected contaminant expulsion after a bioburden testing. For a 10 mL test, the in-process bioburden testing was too diverse to even consider counting (TNTC) (Maillard, Sattar and Bradley, 2016). The unit activity for the test, as observed from the content produced for the microbiological contamination assignment, took about 15 days. Our working hypothesis is that a small number of microscopic organisms, either already existing in the framework or introduced during the technique, caused this little inoculum to form at that time.

• It was hypothesised that microscopic organisms were introduced into the framework. The bioburden described has increased as a result of the use of Bacillus thuringiensis. The use of Bacillus thuringiensis speaks to the worst-case scenarios in this way. The worst-case situation conceivable was that all of this bulk might include protein contaminations. One pg of protein/mL is concentrated in the drug material lot. As a worst-case scenario estimate, a portion of Soliris limited to 120 mL would contain close to 15 pg of the contaminated protein. While this refers to a fictitious worst-case scenario count, the medication procedure's procedure evacuation information shows that the actual expulsion is a few sets of extent greater.

• The risk assessment stated in the microbiological contamination assignment will be updated to include all discharge, reliability, and additional test results as well as the worst-case scenario count for potential pollution. By March 19th, 2013, the revision will be complete (Rihs, Lee and Stout, 2017).
Toxicology Assessment of Calculated Impurities

• The maximum quantity allowed for a drug substance lot was ="" li="" style="box-sizing: inherit;">

• The concentrations of Acinetobacter radioresistens and Bacillus thuringiensis toxins in the medical section were considerably below any targets determined to be associated with any signs or evidence of harm or other discoveries. Proteins from the Bacillus thuringiensis have been linked to danger when used either as a filter in a readily available bug spray (at high exposures) or when ingested in large doses. When administered parenterally at consistent dosages, the decontaminated endotoxin contained by these kinds of tiny organisms was linked to harmfulness. When a safe bargained human got contaminated by all the living life forms, Acinetobacter radioresistens may have been an opportunistic infection.

• The intentional drug lot has the most recent bioburden of 0 CFU/l0 mL and 0.1 EU/mg and negative endotoxin discoveries evaluated contaminations from bioburden at more than l5 pg of Bacillus thuringiensis per 120 mL portion of medication and all-out conceivable human portion level of a range of 3-8 all out dosages, was surveyed related to the writing search on poisonous impacts of the two microscopic organism (Shintani, 2015).

• The small concentrations of Bacillus thuringiensis proteins linked to any unfavourable effects in either in vivo or in vitro tests are much lower than the large concentrations of bacterial protein segment contamination that have been determined as potentially present in the part. Risk assessments of yields with far greater concentrations of Bacillus thuringiensis assumed that poison crops rather than those that transmitted Bacillus thuringiensis from medication posed no threat to harvest workers or yield buyers. In this way, the risk of clinically unfavourable events connected to the structure of this pharmacological component is regarded as extremely low to negligible.

Adverse Event Evaluation in the context of microbiological contamination assignment

The SOP QC-0394-required hazard analysis for a lot implied that there was little risk to the lot's quality of drugs. The underlying conclusion of safety is supported by other risk assessment methods such as possible impurity amount estimation, toxicological review, and an audit of unfavourable occasion data. The company believes that FDA expects the hazard appraisal to analyse any potential polluting influences produced, such as non-host cell byproducts, in situations where in-process bioburden activity limitations are exceeded, and to establish the procedure polluting influence clearance. Additionally, for the related Soliris medication substance lot, explicit scientific testing beyond routine discharge and dependability needs to be carried out to see whether any prospective contaminating influences made were eliminated during the cleaning process. To ensure that requests for chance appraisals are satisfied, the organisation will assess investigative techniques and methodologies. Future risk assessments that are used to determine the optimum behaviour of lots that undergo an in-process bioburden activity limit trip will include information to satisfy FDA requirements. Alexion will complete SOP QC-0394's update "By March 31, 2013, Bioburden Microbial Risk Management and Assessment (Silbergeld, 2017).

2. Your company has not done enough to stop microbial contamination from happening again during the drug manufacturing process and has not done enough to assess whether the bioreactor contamination episodes are connected.
Response

• In accordance with SOP TMS-0027, "Bioreactor Contamination Investigation," and SOP TMS-0028, "Purification Equipment Investigation," the company has completed an examination of the bioreactor and the occasions of contamination "The methodology expects examinations to be finished by a cross-useful group of topic specialists from Technical Services, Manufacturing, Facilities, Quality Control, and Quality Assurance. Exams conducted in accordance with this SOP are effective inquiries and evaluations of factors to determine the root cause(s) or the most likely root cause (s). The system needs an evaluation of labour, materials, hardware, and environmental factors (Silbergeld, 2017).

•The most likely primary drivers identified with working technique were detected during the deviation examinations in April 2011 and March 2012. In particular, a poor methodology that failed to recognise the possible impact of leftover WFI in a significant amount prior to employing may have contributed to the April 2011 incident. Estimates of counteractive action included adjustments to trustworthiness tests and venting methodologies. To assist with the assessment, the corporation has hired counselling companies. To aid in the completion of research and remediation efforts, generation in the bioreactors has been halted. Initial findings suggest ineffective SIP combined with ineffective routine CIP of non-routine soils. Because of a delay in assembling for safeguard support, non-routine soils were provided, as mentioned in the microbiological contamination assignment. Following the protracted deferral, each bioreactor contamination that occurred in July and August 2012 was initiated. All evidence to date shows that the most recent contaminations' causes are unrelated to the previously established primary driver. Once the examination is complete, the organisation will submit a report to the FDA. By May 1, 2013, the FDA will receive the reports (or an update of the reports that have not yet been completed). There is no correlation between the bioreactor microbial contamination events and the data acquired during all studies. The evaluation will also determine whether there are any shared traits between the early and late instances that call for additional deterrent measures. Additionally, living things isolated from current events like ecological seclusions will be compared to strains that can be found from earlier instances of contamination. The findings will be used to support and rule out putative underlying root causes for ongoing events (Tidswell, Tirumalai and Hussong, 2019).

3. The firm has not appropriately analysed necessitation for an increased frequency of a sporicidal chemical throughout the clean rooms.

Response

• Since January 2011, the corporation has changed its usage of sporicidal operators on two events because of an intensive survey of environmental checking (EM) facts. The frequency of sporicidal cleaning up in the room was increased in response to the outing rate and taking into account the probable impact of generation activities in the context of this microbiological contamination assignment.

• In accordance with the study done for the microbiological contamination assignment, additional surface sites will be included for research to enhance the ability to identify potential sources of Bacillus thuringiensis and other spore-formers. The additional testing locations were chosen to consider several factors, such as proximity to the bioreactor and equipment and potential for heavy staff traffic. Starting on May 9, 2013, additional testing and checking will be done. Depending on the results of the investigation into the bioreactor contamination incidents that occurred in July and August 2012, this may be expanded. The bioreactor decontamination inspection reports or update will include a note with information acquired as a result of the extended examining as one of their main components on April 1, 2013. (Wiencek, 2018).

• Assembling effort will be devoted toward assessing the likelihood of cleaning with sporicidal agents occurring again, and the results will be recorded by way of a risk assessment supporting any following efforts. By August 31st, 2013, the risk assessment will be complete (Wiencek, 2018).

Conclusion

We accept that the activity plans and deadlines described in this response letter discharge our obligation to monitor the 483 and its associated reprimand letter in a comprehensive manner based on the overall analysis performed for the microbiological contamination assignment. All applicable staff members who will be affected by the upgrades have undergone extensive training in conjunction with changes to approaches and tactics. Within fifteen (15) working days of our receiving your notification letter, we will give you a free adjustment of our beneficial exercises.

Additionally, we ask that the FDA publish our response to the Warning Letter on the FDA website. If it's okay with you, consider this letter to be a recommendation for publication on the FDA website.

Sincerely,
/S/ /S/

References

HBD106 Human Biology and Disease Assignment Sample

Individual/Group - Individual

Length - 500 words (+/- 10%)

Learning Outcomes

The Subject Learning Outcomes demonstrated by the successful completion of the task below include:

b) Discuss the role of immunological responses related to inflammation, infection, hypersensitivity, autoimmunity and immunisation.

c) Explain the body’s response to injury and disease at both the cellular and tissue levels.

d) Compare and contrast microorganism types and discuss in the context of immunity, infection control and public health.

e) Identify and describe the pathophysiology, aetiology and clinical manifestations of the common health disorders studied.

f) Explain the underlying pathological and physiological principles as they relate to degeneration and aging.

g) Identify and explore the role social and environmental factors may have in the prevention or pathogenesis of common health disorders.

Task Instructions for Biology Assignment :

To complete this assessment task, your plan must follow these steps:

1) Choose any communicable or non-communicable disease that has been discussed in this course.

2) Research this condition and the bodily systems that it impacts.

3) Outline a plan for your information sheet.

• Your plan for the information sheet should include information about:

(a) Burden of disease e.g., the impact of living with the condition, Disability-Adjusted Life years, Quality-Adjusted Life years, the impact on the medical system and the economy

(b) Clinical manifestations,

(c) Information on investigations and treatments based on the latest scientific evidence.

(i) You can also include any screening tests and links to other helpfulresources.

4) Describe the aetiology and pathophysiological process

5) Identify and utilise medical terminologies/ definitions throughout (remember that your audience is educated medical professionals).

Please also note that

• You are required to present your own original work using multiple academic referencesfrom academic books (at least one), journals (at least 2, published in the last 10 years) and other credible sources. Please see rubric for minimum number of references required for each grade.

• You should present your work as double-spaced text. Dot point entries can be used. Pictures and tables can be useful, however ensure you use correct titles/legends and refer to these in your text.

• Academic references are to be included on a separate page using APA guidelines.

Solution

Introduction

Asthma islong-lasting inflammatory disease, affects the routes of ait in the lungs. Its crucialfeatures include adjustable and repeated indications, reversible flow of airobstacle, and easily activated bronchospasms (Kuruvilla et al., 2019).

Discussion

Burden of disease

The International Study of Asthma and Allergies in Childhood (ISAAC) studied aillustrative sample of 938,687 adolescents between the ages of 13 and 14 in 239 locations in 99 countries between 2020 and 2022 (Dharmage et al., 2019). The most striking finding was the degree to which recent wheeze incidence varied across countries and between areas within those countries. The highest incidence (30%) is often originate in the countries of Australasia, Europe, and parts of Latin America along with North America (Kuruvilla et al., 2019). The bottommostcommonness (7%) was originate in the Indian subcontinent, Eastern Mediterranean, Asia-Pacific, and Northern as well as Eastern Europe (Lambrecht et al., 2019).

Figure: Asthma (Cleveland Clinic, 2022)

Clinical manifestation of asthma

Some of the clinical signs and symptoms of asthma include recurrent wheezing fits, tightness in the chest, coughing, and shortness of breath (Levy et al., 2006). The symptoms frequently seem harsher at night or immediately after an individual wakes up. They frequently disappear on their own or following an inhaled pain reliever (Boonpiyathad et al., 2019). In spite of the fact that adult asthma deaths are uncommon and mortality rates are falling throughout the majority of European countries, certain really severe episodes can be deadly (Choi et al., 2021).

Figure: Asthma (Respiratory Health, 2022)

Aetiology and pathophysiology of disease

Although it is common for people to have asthma in their families, neither it is necessary nor sufficient for someone to get asthma (Stern et al., 2020). Anindividual's reaction to ecologicalinductions may also change during the sequence of their lifespan, and the relevant jeopardy factors may change (Menzies-Gow et al., 2021).Asthma attacks the lungs and creates constriction in the airways thus inducing breathlessness among the patient. It has bronchial hyperresponsiveness and variable airway blockage (Hammad & Lambrecht, 2021).

Figure 1: Pathogenesis of Asthma
(Source: Barcik et al., 2020)

Screening test and treatment

For the purpose of determining how much the bronchial tubes have constricted, a test called spirometry evaluates how rapidly and how greatly air one can exhale after taking a deep breath.Deterrence and longstandingorganization of asthma are critical for stopping asthma occurrences from ever happening (Boonpiyathad et al., 2019). Learning to recognize triggers, taking care to avoid triggers, and monitoring breathing to make sure the medications are managing symptoms are the usual steps in therapy. It could be necessary to use a quick-relief inhaler during an asthma attack (McGregor et al., 2019).

Conclusion

From the overheadargument it can be decided that asthma is one of the greatest prevalent diseases in the western countries. It is triggered by different factors like allergens. It can be chronic as well and might be genetic in most of the cases, and in other cases, they might get worse over timehours, minutes, or even secondsresulting in a more significant obstruction of the airway and an attackor worsening of the asthmathat can only be addressed with more medication. 

References