QbD for Biopharma: New Course at PDA FDA Joint Conference

This year's PDA FDA Joint Regulatory Conference in D.C. in mid-September has an excellent program top to bottom. (Here's the agenda.) It will also feature a new course by Anurag Rathore (see yesterday's post on his new book) on QbD for Biopharma.

Rathore has just posted the tentative outline for the course on our LinkedIn group. If you're not a LinkedIn member, here is his overview--comments are welcome as the program is finalized.

Critical Quality Attributes (Patrick Swann): Potential CQAs for Mabs; Biological Activity Matrix; Product-related variants; Characterization of variants and setting limits (ICH Q5E); Clinical pharmacology studies; Specifications (ICH Q6B); Biological characterization

Design Space (Anurag Rathore): Clinical design space; Product design space; Process design space; Case Study I – Establishing process design space for a Pichia fermentation product; Scale down modeling; Failure Mode and Effects Analysis (FMEA); Design of Experiments (DOE); Parameter-parameter interactions; Worst case studies

Group work I (All): Group discussion to identify and list gaps attendees see with respect to molecules under commercialization at present and also legacy products.

Risk Assessment and Management (Patrick Swann): Review of historical approaches; ICH Q9 guidance; Quality risk management process; FMEA

Regulatory Aspects (Patrick Swann): OBP QbD pilot program; Observations based on review of proposals for categorizing quality attributes

Establishing Control Strategy and Lifecycle Management of Design Space (Anurag Rathore): Creating control strategy; Process validation; Filing; Process monitoring; Raw material management; Process analytical technology (PAT); Case Stud II – Multivariate analysis for a mammalian cell culture step

Group work II (All): Group discussion of gaps identified earlier

Wiley Publishes QbD for Biopharma, Edited by Rathore and Mhatre

Wiley and Sons has published the 288-page "Quality by Design for Biopharmaceuticals: Principles and Case Studies," edited by two of biopharma-QbD's leading advocates, Anurag Rathore and Rohin Mhatre.

Expect the book to become one of the definitive resources for QbD, given the impressive list of contributors. For those who don't have the $125 for the cover price right now, the Introductory Chapter by the editors may suffice; it's available here (scroll down to "Product Samples"). It's an excellent overview of basic QbD concepts such as CQA's, Design Space, raw materials and their impact on QbD, and PAT.

--Paul Thomas