Dr_Dan
★★  

2016-10-26 17:11

Posting: # 16754
Views: 1,700
 

 scale up pitfalls [Study Per­for­mance]

Dear all
Provided that a lab scale batch of a generic formulation demonstrated bioequivalence to the RLD how big would be the risk of commercial scale batch to fail?
IMHO factors affecting the formulation after method transfer to the CMO are different manufacturing equipment and different total amounts of drug and excipients. If the formulation and the manufacturing process remains the same and all characteristics and specification of critical quality attributes of the drug product, such as dissolution are met wouldn't it be reasonable to assume bioequivalence for the commercial scale batch? Do you have any experience with failed upscaling?
CPMP/EWP/QWP/1401/98 Rev. 1/ Corr ** states for oral solid forms for systemic action that "the test product should usually originate from a batch of at least 1/10 of production scale or 100,000 units, whichever is greater, unless otherwise justified." Considering this upscaling shouldn´t really be a problem, right?
Looking forward to your reply

Kind regards and have a nice day
Dr_Dan
Activity
 Admin contact
20,134 posts in 4,245 threads, 1,386 registered users;
online 10 (2 registered, 8 guests [including 4 identified bots]).
Forum time (Europe/Vienna): 18:02 CET

A Camel is a Horse designed by committee.    Anonymous

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5