For Immediate Release

Marin Biologic Laboratories Excels in Surprise FDA Inspection for the Second Consecutive Year

NOVATO, CA – August 19, 2024

Marin Biologic Laboratories, a leader in biological and biopharmaceutical development, proudly announces the successful completion of a surprise U.S. Food and Drug Administration (FDA) inspection, marking the second consecutive year of flawless compliance with cGMP standards for commercial drugs at our state-of-the-art facility in Novato, California.

This year’s unannounced audit underscores Marin Biologic Laboratories’ unwavering dedication to maintaining the highest standards of quality and regulatory compliance. The absence of 483s and observations in the inspection report highlights our commitment to excellence and our ability to consistently meet the rigorous demands of the FDA.

Dr. Tania Weiss, Founder, President, and Chief Executive Officer of Marin Biologic Laboratories, remarked, “The success of this surprise FDA inspection is a remarkable achievement and a testament to our team’s relentless focus on quality assurance and regulatory compliance. This milestone reaffirms our steadfast commitment to delivering world-class solutions and upholding the highest standards of safety and efficacy in all our operations.”

The flawless FDA inspection further authorizes Marin Biologic Laboratories to expand its service offerings, enhancing its capacity to drive scientific innovation and contribute significantly to the biopharmaceutical industry.

Dr. Weiss added, “Our team’s dedication and expertise have been instrumental in achieving this milestone. We are excited to continue providing an even broader range of services to our clients, furthering our contribution to the critical field of biopharmaceutical research, development, and commercialization.”

Marin Biologic Laboratories remains at the forefront of delivering successful, creative, and cost-effective solutions to client challenges, consistently generating world-class results. This latest accomplishment solidifies our position as a trusted partner in the biopharmaceutical industry, committed to excellence and continuous improvement.

About Marin Biologic Laboratories (“Marin Bio”)

Marin Biologic Laboratories is a premier contract research organization specializing in the development of biological and biopharmaceutical products. With a focus on quality, innovation, and compliance, Marin Biologic Laboratories provides comprehensive solutions to meet the needs of its clients and drive advancements in biopharmaceutical research and development.

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 has successfully performed services for clients ranging from blue-chip multinationals to start-ups. We collaborate and utilize our scientific expertise in the most creative and effective manner to support the needs of our clients. For more information, please visit www.marinbio.com, call 415-883-8000, or email marinbio378@marinbio.com.

Contact

Marin Biologic Laboratories

Website: www.marinbio.com

Email: info@marinbio.com

Phone: (415) 883-8000

Email: marinbio378@marinbio.com

378 Bel Marin Keys Blvd.• Novato, California 94949 • 415.883.8000 • www.marinbio.com

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