EMD Millipore Receives Recertification of GMP Compliance for Biodevelopment Centre - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

EMD Millipore Receives Recertification of GMP Compliance for Biodevelopment Centre



EMD Millipore reported that its Biodevelopment Centre in Martillac, France, has been recertified by the French National Agency for Medicines and Health Products Safety, the competent authority of France. The certification confirms the 3440 m2 facility complies with the principles of GMP for active substances. The audit included a thorough review of quality systems, supplier management, control of raw materials, documentation, calibration and validation. Prior certification consisted only of stainless steel equipment, while this recertification included complete single-use upstream and downstream suites, as well as a 2 x 1250 L stainless steel suite.

EMD Millipore's Provantage biodevelopment and clinical supply services are delivered at the Martillac, France facility. This approach for biologics manufacturing incorporates technologies in upstream, downstream and single-use systems. This Provantage offering includes process development and GMP drug substance for pre-clinical to Phase II and is available to a global customer base.

Source: EMD Millipore

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
32%
Breakthrough designations
11%
Protecting the supply chain
37%
Expedited reviews of drug submissions
11%
More stakeholder involvement
11%
View Results
Jim Miller Outsourcing Outlook Jim Miller Health Systems Raise the Bar on Reimbursing New Drugs
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerThe Mainstreaming of Continuous Flow API Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler Industry Seeks Clearer Standards for Track and Trace
Siegfried Schmitt Ask the Expert Siegfried SchmittData Integrity
Sandoz Wins Biosimilar Filing Race
NIH Translational Research Partnership Yields Promising Therapy
Clusters set to benefit from improved funding climate but IP rights are even more critical
Supplier Audit Program Marks Progress
FDA, Drug Companies Struggle with Compassionate Use Requests

Click here