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Quality Control for Biologics: What Students in Quality Control Courses Should Know

pharmaceutical quality assurance and quality control

Biologics are pharmaceuticals made from a biological source. Usually antibodies or other proteins, they are derived from living cells and can treat diabetes, cancers, arthritis, and autoimmune disease. This is one of the fastest-growing segments of the industry, and contrasts with the synthesis of chemicals for traditional drugs. Working with organic materials presents challenges that don’t exist in traditional methods.

As you enter into the world of pharmaceutical quality control, you will find that these drugs have a growing presence in pharmacy and you may be required to assure their quality and reliability. Read on for more about quality control for biologics.

What Students in Quality Control Courses Should Know About Proteins

It’s more difficult to control living cells, so producing protein from them can prove less predictable than traditional chemical synthesis. Generally, when manufacturing biologics like vaccines, a bioreactor is used to carry out chemical reactions that make proteins. Unfortunately, even with identical bioreactor processes, different proteins can result, with contrasting activity and glycosylation (sugar modifications).

Proteins need to be analyzed differently for quality assurance
Proteins need to be analyzed differently for quality assurance

The biopharmaceutical industry is growing rapidly as advancements have been made in recombinant DNA, hybridoma technology, gene and cell therapies and tissue engineering. If you are studying pharmaceutical quality assurance and quality control, you will become familiar with manufacturing processes and controls. Because of the speed with which new biopharma products are being manufactured, a traditional method of checking results after the process is complete doesn’t work as well. The industry is moving towards real-time measuring of results and continuous monitoring, as a way to keep pace.

What’s New in the World of Biologics, and how Does it Affect Quality Control?

Gene and cell therapies involve transplanting human genes or cells into existing cells or tissue to repair, improve or replace damaged areas. This can treat or prevent disease, correct genetic disorders, and treat blood or immune disorders. Tissue engineering is a process of mimicking tissues to replace or repair where there is damage or disease. Because of this use of biological materials to treat patients, it is important to consider these methods when developing quality assurance and regulation practices.

If you use your quality assurance diploma to enter into the world of biotechnology, you may be curious about autologous transplantation, where a patient’s own matter is used, instead of allogenic methods using that of another person. Autologous blood transfusions are an example of using a patient’s own tissue to treat them. Blood is collected from the patient, then reintegrated back into their circulation system intravenously. Methods like this are highly personalized with different processing methods, and can present new challenges for shelf life.

Biological materials like blood are used in many treatments, presenting unique quality assurance issues
Biological materials like blood are used in many treatments, presenting unique quality assurance issues

An Intro to Nanofilters for Students Getting a Quality Assurance Diploma

While it is possible to monitor factors like temperature or pH levels within bioreactors, testing the quality of the proteins that are created can only occur after the process is done. This can take months before results are measured and analyzed. Of course, waiting until months after manufacturing to find out that a batch of drugs is not up to par saps resources and wastes time. To speed up the process of monitoring these proteins, a strategy using nanofilters has been developed.

Nanofilters use different sizes of pores to sort proteins by size – indicating which proteins are clumping, a danger to patients. This can be used, when combined with target protein fragments, to identify whether the proteins are properly binding to their intended target. This could also be used to test drugs before they are administered, ensuring safety and that the materials have not degraded before reaching patients.

Are you interested in pharmaceutical quality control courses?

Contact TIPT for more information.

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