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The Biomanufacturing Process

The Biomanufacturing Process. Introduction to Biotechnology. Getting a Drug to Market. US Food and Drug Administration is the main consumer watchdog for pharmaceuticals in the USA. FDA evaluates new drugs (prescription and OTC) before they can be sold.

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The Biomanufacturing Process

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  1. The Biomanufacturing Process Introduction to Biotechnology

  2. Getting a Drug to Market • US Food and Drug Administration is the main consumer watchdog for pharmaceuticals in the USA. • FDA evaluates new drugs (prescription and OTC) before they can be sold. • How would you describe the FDA’s role in regard to consumers?

  3. Getting a Drug to Market • The development of a new drug is lengthy and expensive for BOTH chemical pharmaceutical and biopharmaceutical industries. • As the process moves from lab to manufacturing, the size and variety of jobs grows. • Can you anticipate the types of jobs you might find in biomanufacturing?

  4. Drug Discovery and Testing • In the past, drug discovery was done by trial and error. • With biotechnology, scientists have a better understanding of life processes, which helps the drug discovery process. • Based on your understanding of how genes and proteins work, can you think of any drugs a scientist might go looking for?

  5. Drug Discovery and Testing • Drug discovery begins in the laboratory. • Promising drugs  pre-clinical studies with animals and non-human test systems. • If pre-clinical trials promising, company may file Investigational New Drug Application (IND) with the FDA.

  6. Clinical Trials • Before FDA approval, human studies to test drug effectiveness. • It takes 2-10 years, average 6 years. • If clinical trials indicate drug is safe and effective, the company files a New Drug Application (NDA) with the FDA. • NDA averages 2 years to be approved.

  7. Clinical Trials • Final step in Clinical Trials is Post-Marketing Surveillance • This system monitors the safety of a marketed drug, and includes adverse action reporting from the medical and pharmaceutical communities. • Are drugs ever taken off the market during Post-Marketing Surveillance?

  8. The Manufacturing Process

  9. Production • Synthesis (chemical or cell culture) • First, the materials needed for the creation of the product are prepared. • Second, the product is created, either by chemical synthesis (traditional pharmaceuticals) or through cell culture or fermentation (biomanufacturing).

  10. Purification • Purification is the process of separating the bulk product from the leftover chemicals or cellular byproducts. • What cellular byproducts do you think there would be in biomanufacturing?

  11. Formulation and Final Form • Chemical mixing to blend bulk product (active ingredient) with other substances such as fillers. • Final dosage form preparation • Made into final form (tablets, sterile solutions) • Dispensed into containers • Do you think the final form has any bearing on the sale of a drug product?

  12. Quality Control (QC) • All employees must follow Good Manufacturing Practices (GMP) and FDA regulations. • Quality Control – testing product during stages of the manufacturing process. • Why is quality control important in biomanufacturing?

  13. Quality Assurance (QA) • Quality assurance follows Standard Operating Procedures (SOPs) which define each procedure in detail so it can be performed exactly the same way every time. • Both QA and QC require all process details and checks in writing. • “If it isn’t written down, it never happened.”

  14. Validation • Validation proves that the manufacturing process will produce an exact product when carried out exactly with specified equipment. • Do you know of anything that must be “validated”? Why?

  15. What Quality Means and Why it Matters

  16. The Price of Poor Quality • To be competitive in any industry, companies need to produce high quality products. • What happens to companies when they produce poor quality products?

  17. Five Rules for Quality • Understand customer needs. • Say what you do – write down procedures. • Do what you say – follow procedures. • Prove it – keep records. • Improve it.

  18. Standard Operating Procedures • SOPs define a particular process in detail so that it can be performed the same way every time. • Biomanufacturing is regulated by the FDA, which requires companies to follow their SOPs. • Regulations that regulate pharmaceutical manufacturing are known as Good Manufacturing Practices (GMPs).

  19. Summary • How does a drug get to market? • What is a clinical trial? • What organization regulates biomanufacturing? • What does quality mean? • What are standard operating procedures and regulations?

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