Quality by Design for Biotechnology Products—Part 2 - Second in a three-part series that discusses the complexities of QbD implementation in biotech development. - BioPharm International
Table 1. Suggested placement of QbD information in the common technical document (CTD) for the drug substance
Module 1: Administrative Information. The proposed post-approval management plan may be included in this section.
Module 2: Quality Overall Summary. The role of the Module 2 Quality Overall Summary (QOS) in a "QbD" application is not expected to differ significantly from
the QOS in a more traditional application, however, there is the opportunity to consolidate or cross-reference data that comprehensively
describes the design space and control strategies.
Table 2a. Suggested placement of Quality by Design information in the common technical document (CTD) for the drug product
(DP)
Module 3: Drug Substance and Drug Product. Tables 1 and 2 provide possible locations for the QbD information about the drug substance and drug product. Sections that
do not contain QbD information and contain only information that would be included in a traditional application are identified
with the term "traditional content." In this proposal, section 3.2.S.2.6 (Manufacturing Process Development) is the key QbD
section for drug substance and Section 3.2.P.2 (Pharmaceutical Development) is the key QbD section for drug product.
PART 3 OF THIS ARTICLE
Table 2b. Suggested placement of Quality by Design information in the common technical document (CTD) for the drug product
(DP), continued.
Part 3 of this article will appear in the January 2010 issue. It will discuss continuous verification and post-approval changes,
including topics such as verification at large scale, refinement of the design space, process changes and comparability, comparability
protocols and expanded change protocols, marketed products, and a CMC post-approval management plan. It will also include
the overall conclusions.
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, Towns_John_K@lilly.com
REFERENCES
1. Reason J. Human error: models and management. BMJ. 2000 Mar 18;320(7237):768–70.
2. Glodek M, Liebowitz S, McCarthy R, et al. Process robustness—A PQRI white paper. Pharm Eng. 2006 Nov/Dec;26(6):1–11.
3. Parenteral Drug Association. PDA Technical Report 42. Process validation of protein manufacturing. 2005 Sep;59(S-4):1–28.
Bethesda, MD: PDA.
Anurag S. Rathore, PhD, is a consultant, Biotech CMC Issues, and a member of the faculty in the department of chemical engineering at the Indian Institute of Technology. Rathore is also a member of BioPharm International's Editorial Advisory Board.
Articles by Anurag S. Rathore, PhD
