GMP Certification Extended for Cobra Biologics - - BioPharm International

ADVERTISEMENT

GMP Certification Extended for Cobra Biologics



Cobra Biologics, an international CMO of biologics andpharmaceuticals, reported that its GMP Compliance Certification has been extended to include QC testing and release of customers’ registered products for in-market supply.

Following an inspection at the company’s center of excellence for mammalian antibody and recombinant protein production in Södertälje, Sweden, the the Läkemedelsverket (Medical Products Agency) has considered that the facility complies with the principles and guidelines of GMP in the Commission Directive 2003/94/EC for Human Medicinal, and Investigational Medicinal, Products.

This improved certification for biological medicinal products includes the manufacturing of active substances by culture of mammalian cells, the storage of both mammalian and microbial cell banks, the release testing of protein for clinical trials, and the QC testing of registered products.

Source: Cobra Biologics

blog comments powered by Disqus

ADVERTISEMENT

ADVERTISEMENT

NIH Seeks to Improve Vaccine Response with New Adjuvants
September 30, 2014
New Report Details Players and Pipelines in the Biosimilar Space
September 30, 2014
Baxter International Plans to Open R&D Center for Baxalta
September 30, 2014
FDA Releases First-Ever Purple Book for Biosimilar Characterization
September 26, 2014
FDA and NIH Win Award for IP Licensing of Meningitis Vaccine
September 26, 2014
Author Guidelines

Click here