RAPS

Comparability protocols: Final guidance incorporates ICH Q12, allows for API supplier changes

The US Food and Drug Administration’s (FDA) last week released a final guidance to assist the pharmaceutical industry in submitting comparability protocols for postapproval manufacturing changes. The ...
Royal Society of Chemistry

Comparability Protocols (CPs): How and when to use them for post approval changes

This Comparability Protocols training will provide you with the basics for use as well as provide you with new and expanded ways of using CPs. It will also assist you in finding ways to help shorten ...
PharmTech

FDA Issues Guidance on Comparability Protocols

The guidance discusses the implementation of CMC postapproval changes through a comparability protocol. On April 19, 2016, FDA issued guidance on how to implement a chemistry, manufacturing, and ...
FiercePharma

Emergent BioSolutions and FDA Finalize Comparability Protocols Enabling Manufacturing of BioThrax Consistency Lots in Building 55

ROCKVILLE, Md.--(BUSINESS WIRE)--April 22, 2014-- Emergent BioSolutions Inc. (NYSE:EBS) today announced that it has initiated manufacturing of BioThrax(R) (Anthrax Vaccine Adsorbed) consistency lots ...
JD Supra

FDA’s Much Anticipated New Cell and Gene Therapy Guidance Outlines a Conservative Approach to Manufacturing Changes

Biologics have long been defined by their processes, raising complicated questions about how to assess the effect of manufacturing changes on product quality 1 —i.e., whether pre- and post-change ...
GEN

Determination of Comparability Criteria

To establish whether clinical-product quality remains constant when making a process change can be a challenging exercise. Limited data availability further complicates the assessment of whether the ...