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Please answer - Quality control of biopharmaceutical drugs
#1
Hi ,

I have an exam and need answers for the following two questions about the quality control of biopharmaceutical drugs:

1- Explain why biological drugs are considered to differ from synthetic chemical drugs.

2- Discuss reasons why the specification and analysis of biological drugs differs from that for chemical drugs
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#2
A (pharmaceutical) drug is a compound that has a physiological effect on a person when administered. Usually the physiological effect produced by a drug is due to its interaction with the proteins of the target cell. However, no drug is specific for a protein or even a cell hence it causes side effects.

A drug’s composition can be divided into two main ingredients –active ingredient and inactive ingredient. The active pharmaceutical ingredient (API) contains the main chemical salt which will be responsible for the disease treatment. For e.g the API of aspirin is acetylsalicylic acid. The inactive ingredient includes any of the other compounds added during the manufacturing process that are responsible for drug delivery, taste, color etc. The selection of the inactive ingredient (excipient) depends on the type of drug, route of administration and requirements. A common example of the excipient is gelatin which is used coat a wide range of drugs.

Synthetic drug is a pharmaceutical drug that is structurally similar to a naturally occurring drug (e.g. opiates, cocaine). However, they can also be completely synthetic and derived from a parent chemical compound.

A biopharmaceutical drug is a pharmaceutical drug produced using biotechnology techniques. It can be a protein, nucleic acid, and attenuated or killed microorganisms. These drugs aren’t derived by extraction from a naturally occurring cell. The first biopharmaceutical drug to be produced was human insulin in the 1980s. Till date a large variety of vaccines, hormones, growth factors have been produced using biotechnology, all of which fall under biopharmaceutics.

The analysis of a pharmaceutical drug provides information on the identity, purity, content and stability of starting materials, excipients and active pharmaceutical ingredients (APIs. Impurities usually stem from the synthesis of the active ingredient; they are usually monitored according to the guidelines of the ICH and other local regulatory bodies. Specifications of a pharmaceutical drug, on the other hand, are lists of tests and analyses that determine the tolerance limits for the drug on criteria like drug purity, dosage, dissolution rate etc.

The difference in analysis and specifications for a chemical drug and a biopharmaceutical drug arise due to their different composition and manufacturing processes. However, ICH advises that specifications for any pharmaceutical drug be provided on the following fronts:
- Appearance and general state
- Identity ( qualitative test for composition)
- Potency
- Quantity
- Purity and impurities

The basic screening tests for chemical drugs involve testing for microbial content, alcohol content, antioxidant preservative content etc. On the other hand, basic screening tests for biopharmaceutical drugs involve chromatography, spectroscopy and electrophoretic tests.
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