Quality by Design for Biotechnology Products—Part 3 - Guidance from the Quality by Design Working Group of the PhRMA Biologics and Biotechnology Leadership Committee on how to apply ICH Q8,

ADVERTISEMENT

Quality by Design for Biotechnology Products—Part 3
Guidance from the Quality by Design Working Group of the PhRMA Biologics and Biotechnology Leadership Committee on how to apply ICH Q8, Q8R1, Q9, and Q10 to biopharmaceuticals.


BioPharm International
Volume 23, Issue 1

Taruna Arora is a principal scientist, protein science, Roger Greene is the director of regulatory affairs, Jennifer Mercer is the director of regulatory affairs, CMC, and Paul Tsang is the executive director of quality, all at Amgen Inc.; Meg Casais is the director of global regulatory affairs, CMC, and Stuart Feldman is the director/CMC, global regulatory affairs, both at Schering Plough; Jutta Look is the senior manager, CMC Regulatory Affairs at Novartis Pharma AG; Tony Lubiniecki is the vice president of biopharmaceutical development & marketed product support at Centocor R&D, Inc.; Joseph Mezzatesta is the assistant director of regulatory CMC, corporate regulatory affairs, at Sanofi-Aventis; Stefanie Pluschkell is an associate research fellow in global CMC, biologics and devices, at Pfizer Inc.; Mark Rosolowsky is the executive director of global regulatory sciences–CMC at Bristol Myers Squibb; Anurag Rathore is a biotech CMC consultant and faculty member at the Indian Institute of Technology, Delhi, India; Mark Schenerman is the vice president of analytical biochemistry at MedImmune; Tim Schofield is the director of US regulatory affairs at GlaxoSmithKline; Samantha Sheridan is the director of regulatory affairs at Shire Pharmaceuticals; Paul Smock is a director and quality product leader in Wyeth Biotech, Wyeth Pharmaceuticals; Sally Anliker is the director of regulatory affairs CMC, Lois Atkins is a principal consultant, CMC regulatory affairs, Bernerd McGarvey is an engineering advisor in the process engineering center, Bruce Meiklejohn is a principal fellow, regulatory COE-biotech, Jim Precup is a research scientist in manufacturing, science and technology, and John Towns is the senior director of global CMC regulatory affairs, all at Eli Lilly and Company. Towns is also the chair of the working group, 317.276.4079,
.

REFERENCES

1. Submission of quality information for biotechnology products in the office of biotechnology products; notice of pilot program. Federal Register. 2 July 2008;73(128):37972–4.

2. Harms J, Wang X, Kim T, Yang J, Rathore AS. Defining design space for biotech products: case study of pichia pastoris fermentation. Biotech Prog. 2008;24:655–62.

3. US Food and Drug Administration. Guidance for industry (draft): process validation: General principles and practices. Rockville, MD: 2008 Nov.

4. US FDA. Guidance for industry: Q5E. Comparability of biotechnological/biological products subject to changes in their manufacturing process. Rockville, MD: 2005 June.

5. US FDA. Guidance for industry (Draft): Comparability protocols —chemistry, manufacturing, and controls information. Rockville, MD: 2003 Feb.

6. Towns J, Webber K. Demonstrating Comparability for Well-Characterized Biotechnology Products: Early Phase, Late Phase and Post-Approval, BioProcess International, Feb 2008;6(2);32–43.

7. Nasr M. Presentation at the AAPS Workshop on Pharmaceutical Quality Assessment presentation; 4 Oct 2005; Bethesda, MD.


blog comments powered by Disqus

ADVERTISEMENT

ADVERTISEMENT

New Tax Rules May Deter Future Pharma M&A
October 1, 2014
NIH Seeks to Improve Vaccine Response with New Adjuvants
September 30, 2014
New Report Details Players and Pipelines in the Biosimilar Space
September 30, 2014
Baxter International Plans to Open R&D Center for Baxalta
September 30, 2014
FDA Releases First-Ever Purple Book for Biosimilar Characterization
September 26, 2014
Author Guidelines
Source: BioPharm International,
Click here