What s ahead for pharmaceutical biotechnology?

Transcription

1 What s ahead for pharmaceutical biotechnology? BIRS/SQA Summit on Regulatory Excellence Purdue University, West Lafayette, IN May 18 19, 2017 ELIZABETH M. TOPP, PH.D. DANE O. KILDSIG CHAIR AND DEPARTMENT HEAD DEPARTMENT OF INDUSTRIAL AND PHYSICAL PHARMACY PURDUE UNIVERSITY 1 Cell based therapies AND DISTRIBUTED MANUFACTURING 2 1

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3 cgmp Autologous vs. Allogenic Adapted from 5 Local, distributed cgmp manufacturing? Dispensing? Adapted from 6 3

4 news/print meds warns against tablet splitting save money/ 7 Biosimilars AND ANALYTICAL RESOLUTION IN QA/QC 8 4

5 breast cancer drug dr mark j winter.html breast cancer drug dr mark j winter.html 9 Aspirin MW = 180 g/mol Monoclonal antibody MW = 150,000 g/mol 833x larger S. Kozlowski et al., NEJM, 365/5: ,

6 A generic drug is identical to a brand name drug in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use chemically identical to [the] branded counterpart How (bio)similar is (bio)similar enough? Biosimilars are highly similar to an already FDAapproved biological product, known as the biological reference product [and have] no clinically meaningful differences from the reference product A statistics issue? Not different Low resolution analytical methods Small sample number (n) Different Higher resolution analytical methods Larger sample number (n) 12 6

7 Which differences matter? Where do differences matter? 13 Continuous Manufacturing AND THE MEANING OF BATCH 14 7

8 solid oral dosage processing And Batch Manufacturing Pharmaceuticals.ashx 16 8

9 Batch vs. continuous BATCH MANUFACTURING Standard unit operations processing with limited process control Off line testing after each unit operation and for final product Regular cleaning and sterilization Familiar Regulatory acceptability CONTINU0US MANUFACTURING Smaller equipment and facilities, reduced capital cost Process efficiency Process flexibility Shorter processing time Reduced manual handling In line monitoring Closed loop process control Real time release testing of finished product 17 What s a batch? 21 CFR Batch: a specific quantity of a drug or other material that is intended to have uniform character and quality, within specified limits, and is produced according to a single manufacturing order during the same cycle of manufacture Lot: a batch, or a specific identified portion of a batch, having uniform character and quality within specified limits; or, in the case of a drug product produced by continuous process, it is a specific identified amount produced in a unit of time or quantity

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11 Keeping Up RESOURCES FOR YOUR ONGOING LEARNING 21 bootcamp vs college 22 11

12 Colleges and academic units Biotechnology Innovation and Regulatory Science $70 M federal $129 M state, industry Technology innovation Workforce development 24 12

13 Re cap Cell based therapies and distributed manufacturing Biosimilars and analytical resolution Continuous manufacturing and the meaning of batch Keeping up and new types of education 25 13