Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Biotech QbD Encounters Uncertainties Over Definitions and Regulatory Relief

This article was originally published in The Gold Sheet

Executive Summary

As biotech firms begin to pilot QbD they wrestle with FDA over non-critical process parameters, postapproval changes and more. They are exploring how to define design spaces, change them, identify their edges. And they're still wondering what regulatory relief they might get in return for investing in quality-by-design studies.

You may also be interested in...



New Ways to Ascertain Critical Attributes of Monoclonal Antibodies Explored

Ways to assess criticality of MAb quality attributes explored by FDA and industry biotech QbD experts. FDA official suggests borrowing from ICH Q5E guideline for biologics comparability. This could be particularly useful for distinguishing impurities from variants. Biotech experts agree that risk filtering is the best risk assessment method for this task. Medimmune uses risk filtering to show why FDA can safely ignore glycosylation for one compound. A suggestion that companies share platform knowledge could radically alter playing field, given that most applicants lack such platforms. Conformia goes bankrupt but its mock antibody lives on. CMC strategy forum to explore QbD risk assessment process in context of production bioreactor.

Biotech QbD Pilot to Explore ‘Expanded Change Protocols'

Quality-by-design and risk management for biotech products will be explored in an FDA pilot program modeled after agency’s small-molecule CMC review pilot. New program will address not just biotech NDAs and BLAs but also manufacturing supplements using new ‘expanded change protocols.’ FDA seeks diverse array of pilots, including proposals for monoclonal antibody platforms, protein therapeutics, compliance-related issues, and novel approaches to linking attributes to safety and efficacy. Acceptance criteria discussed. Limited to 15 pilots.

McKinsey Survey Highlights Progress, Challenges in Adoption of QbD

Drug manufacturers are adopting QbD but there are exceptions, especially among some generics firms, McKinsey finds in industry survey. The top challenge to further adoption: misalignment between R&D and commercial operations. Second is a lack of belief in the business case. However, the cost turns out to be low and the financial reward high, McKinsey says.

UsernamePublicRestriction

Register

ID1130765

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel