APPLYING QUALITY BY DESIGN TO BIOPHARMACEUTICALS is testing the viability of the definitions that have been jelling in the small-molecule context. Establishing the linkage between quality attributes and clinical performance – a foundation block for the quality-by-design structure – is a particular challenge in the biotech arena, and pathways for tightening this linkage are being explored and discussed. At recent workshops on QbD for biopharmaceuticals, participants analyzed where the biotech industry is on the learning curve and shared ideas on how to advance the progress. A QbD biotech submission pilot, expanded comparability protocols for defining the design space and reducing change filing burdens, and a consortium to pull together knowledge on the product attribute/clinical performance relationship are among the ideas on the table in the U.S. Regulators and industry are also meeting in Europe to advance the QbD initiative in the biopharmaceutical area. Implementation of the ICH guidelines Q8-10 for both drugs and biologics is drawing debate, and an industry initiative is underway to help solve the practical problems involved.
CONTENTS:
3……Product Design Space In focus
5……Process Map Guides Design Space
5……Biotech firms Striving To Keep Pace
13….Dialogue Ongoing At Strategy forum
17….Product Is Process vs. QbD
18….Biotech Pilot Under Consideration
20….Protocols Could House Design Space
21….Expanded Protocols In Applications?
22….DOE/Risk Handling Need Training
23….To QbD Or Not To QbD?
24….International Harmonization Is Key
27….Inspection Guidance Also Needed
30….EU Advancing On Learning Curve
31….ISPE Launches QbD Initiative
34….From High ICH Level To Shop Floor
35….Biologics Pose Diverse Challenges
