Lecture+1.pdf - Cell Culture Process for Recombinant Protein Production Lecture 1 Cell Culture Technology by Sadettin S Ozturk Ph.D Sadettin S Ozturk

Lecture+1.pdf - Cell Culture Process for Recombinant...

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Sadettin S. Ozturk, Ph.D. Cell Culture Process for Recombinant Protein Production Lecture 1: Cell Culture Technology by Sadettin S. Ozturk, Ph.D 1 1 Sadettin S. Ozturk, Ph.D. Outline Biopharmaceuticals: Medicines from recombinant DNA technology Host cell options and microbial systems Cell culture technology Complexities and challenges in cell culture systems Alternatives to cell culture systems Cell culture: current state-of-the-art New directions in cell culture 2 2
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Sadettin S. Ozturk, Ph.D. Insert DNA into host cell line The Industry of Biopharmaceuticals Started with Recombinant DNA Technology in 1980s Grow cells in Bioreactors Separate cells out, collect product Purify Product Host Cell Identify the gene and DNA to treat the disease Formulate and Fill 3 3 Sadettin S. Ozturk, Ph.D. Since 1980s Many Biopharmaceuticals Got Approval as Medicines 4 4
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Sadettin S. Ozturk, Ph.D. Biopharmaceuticals are now a Major Player in Pharmaceutical Industry 5 Small molecules Biopharmaceuticals 5 Sadettin S. Ozturk, Ph.D. Small Molecules vs. Biopharmaceuticals Sales: US Market 6 6
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Sadettin S. Ozturk, Ph.D. Global Biopharmaceuticals Sales were $380 Bln in 2019 CAGR: Compound Annual Growth Rate 7 7 Sadettin S. Ozturk, Ph.D. Worldwide Revenues: 7 of the top 10 Drugs are Biopharmaceuticals 8 CEN News, Volume 93 Issue 48, p. 19, Issue Date: December 7, 2015 8
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Sadettin S. Ozturk, Ph.D. Biopharmaceutical Market is Concentrated in the Western World, because People can Afford Expensive Medicines 9 9 Sadettin S. Ozturk, Ph.D. Medical Treatment using Biopharmaceuticals is Very Expensive 10 10
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Sadettin S. Ozturk, Ph.D. Why are Biopharmaceuticals Very Expensive: They are More Complicated than Chemical Drugs, More Difficult to Make Aspirin 180 daltons mAb 150,000 daltons Factor VIII ~250,000 dalton Insulin 5,700 daltons 11 11 Sadettin S. Ozturk, Ph.D. Why are Biopharmaceuticals Very Expensive: The Drug Development Process is Very Long, Expensive, and Risky 12 Review Approval Reg. Filing Phase III Clinical Trials Submit BLA Early Clinical Development Phase II Clinical Trials Manufacturing Activities Late Clinical Development Clinical and Product Development Activities Ph I Batch Process Validation Launch Preparation Year -2 Year 1 Year 2 Year 3 Year 4 Year 5 Preclinical Studies Target Research Phase I Clinical Trials Submit IND BLA Prep Tox Mat Ph II Batch Ph III Batch Process Development Activities Process Characterization Late Phase Process Dev Early Phase Process Development Tech Transfer BLA Prep Support Year 0 Year 6 IND: Investigational new drug application (first in human) (Clinical Trial Application, CTA in EU) BLA: Biologics license application (Marketing Authorization Application, MAA in EU) 12
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Sadettin S. Ozturk, Ph.D. Genetic Engineered Organisms to Produce Biopharmaceuticals: Host Options 13 13 Sadettin S. Ozturk, Ph.D.
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