FOR IMMEDIATE RELEASE
Marin Biologic Laboratories Passes FDA Inspection, Expands Services
NOVATO, CA – May 23, 2023
Marin Biologic Laboratories, a leading contract research organization in the field of biological and biopharmaceutical development, proudly announces the successful completion of a U.S. Food and Drug Administration (FDA) inspection for commercial drugs at its state-of-the-art facility in Novato, California.
The rigorous inspection confirms Marin Biologic Laboratories' compliance with Current Good Manufacturing Practices (cGMP). The rigor of cGMP for commercial drugs is significantly greater than that for early clinical phase pharmaceuticals.
Tania Weiss, Ph.D., MarinBio Founder, President, and Chief Executive Officer, said, "The successful FDA inspection represents a significant milestone for Marin Biologic Laboratories. It is a testament to our unwavering commitment to world-class quality, continuous improvement, and the highest standards of safety and efficacy in all our operations."
With this accomplishment, Marin Biologic Laboratories is now authorized to offer an expanded range of services, paving the way for greater scientific advancement.
Dr. Weiss added, "Our dedicated team's relentless focus on quality assurance and regulatory compliance was instrumental in achieving this milestone. We now look forward to providing an even broader range of services to our clients, enhancing our contribution to the critical field of biopharmaceutical research/development/commercialization."
Dr. Tania Weiss, who founded Marin Biologic Laboratories, is renowned for providing successful, creative, and cost-effective solutions to client problems, consistently generating world-class results.
About Marin Biologic Laboratories
Marin Biological Laboratories is a contract laboratory that serves the pharmaceutical, biotech, diagnostic and medical device sectors. Marin Bio has been operating for more than 25 years and takes pride in its’ science expertise. We focus on timely and effective communication with our clients.
Marin Bio specializes in the development and validation of assays, including:
- Cell based assays, proliferation, toxicity, and expression assays
- GMP potency bioassays, GLP assays
- ELISA, PK and PD studies, immunogenicity (Anti-Drug Antibodies), neutralizing antibodies
- Humoral and cellular immunity assays
- Molecular & Biochemical services, protein production, purification, enzyme assays, cloning transfections
- Radioactive procedures and analysis
Marin Bio have successfully performed services for clients ranging from blue chip multinationals and start-ups.
We collaborate and utilize our scientific expertise in the most creative and effective manner to support the needs of our clients.
Kirit Patel, J.D., MBA., Director of Business Development
Marin Biologic Laboratories
378 Bel Marin Keys Blvd.
Novato, CA 94949
Email: [email protected]