GMP Certification Extended for Cobra Biologics - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

GMP Certification Extended for Cobra Biologics


PTSM: Pharmaceutical Technology Sourcing and Management
Volume 10, Issue 3

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

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

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

Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
70%
Breakthrough designations
4%
Protecting the supply chain
17%
Expedited reviews of drug submissions
2%
More stakeholder involvement
7%
View Results
Eric Langerr Outsourcing Outlook Eric LangerRelationship-building at Top of Mind for Clients
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerRisk Reduction Top Driver for Biopharmaceutical Raw Material Development
Jill Wechsler Regulatory Watch Jill Wechsler Changes and Challenges for Generic Drugs
Faiz Kermaini Industry Insider Faiz KermainiNo Signs of a Slowdown in Mergers
CMOs and the Track-and-Trace Race: Are You Engaged Yet?
Ebola Outbreak Raises Ethical Issues
Better Comms Means a Fitter Future for Pharma, Part 2: Realizing the Benefits of Unified Communications
Better Comms Means a Fitter Future for Pharma, Part 1: Challenges and Changes
Sandoz Wins Biosimilar Filing Race
Source: PTSM: Pharmaceutical Technology Sourcing and Management,
Click here