Breakthrough Therapies Raise Manufacturing Issues - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Breakthrough Therapies Raise Manufacturing Issues



FDA officials are working with drug manufacturers to ensure that accelerated development of new breakthrough therapies yields high-quality products for patients. A risk is that evaluations based on limited stability data and “provisional” specifications could mask safety issues. These challenges were discussed at the November ISPE annual meeting, along with innovative manufacturing strategies that can accelerate quality production, such as continual manufacturing systems, using a clinical manufacturing site for initial commercial production, or producing clinical supplies in a commercial site.

Sarah Miksinski, acting director of the Division of New Drug Quality Assessment 2 in the Office of New Drug Quality Assessment, emphasized the importance of manufacturers discussing such options with the agency early in development so that the agency can anticipate a filing with limited data and form an appropriate CMC review team. Early discussion of development plans also permits FDA to assess the potential manufacturing site to determine if an inspection will be needed, while also learning of any new technologies or quality-by-design approaches.  

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
Which of the following business challenge poses the greatest threat to your company?
Building a sustainable pipeline of products
Attracting a skilled workforce
Obtaining/maintaining adequate financing
Regulatory compliance
Building a sustainable pipeline of products
27%
Attracting a skilled workforce
27%
Obtaining/maintaining adequate financing
14%
Regulatory compliance
32%
View Results
Eric Langer Outsourcing Outlook Eric LangerBiopharma Outsourcing Activities Update
Cynthia Challener, PhD Ingredients Insider Cynthia Challener, PhDAppropriate Process Design Critical for Commercial Manufacture of Highly Potent APIs
Jill Wechsler Regulatory Watch Jill Wechsler FDA and Manufacturers Seek a More Secure Drug Supply Chain
Sean Milmo European Regulatory WatchSean MilmoQuality by Design?Bridging the Gap between Concept and Implementation
Report: Pfizer Makes $101 Billion Offer to AstraZeneca
Medicare Payment Data Raises Questions About Drug Costs
FDA Wants You!
A New Strategy to Tackle Antibiotic Resistance
Drug-Diagnostic Development Stymied by Payer Concerns

Click here