Gary Ritchie Community Member 3 Posts
Re: API Sterility24 February 2015 at 3:37pm
Biologic drug substances are sterile materials by virtue of their production (either by cell culture or fermentation, both which are maintained under strict antifungal, antimicrobial and antiviral controlled conditions) and route of adminstration which is typically an injection after being reconstituted with sterile water for injection, USP (SWFI), Ringers Soution or other carrier vehicle) all of which must be sterile or rendered sterile. That being said, other biologic manufacturing and routes of administration techniques are mandated to be conducted under the Food, Drug and Cosmetic Act current good manufacturing practices (cGMPs) or the Public Health Service (PHS) regulations which require that drugs be tested to minimum standards of purity, safety and efficacy. Many biologic drug standards that may or may not necessarily be a monograph item of the United States Pharmacopeia must comply with requirements for sterility during the manufacture, packaging and distribution of the drug substance and drug product.
Should an API manufactured by biological or biotechnological process be consider not sterile?
Have an insight or suggestion?
Login or register to post a comment.