Alameda, CA, and Novato, CA – September 9, 2024

Marin Biologic Laboratories, a premier provider of cell biology and biologics testing services, and Emery Pharma, a leader in bioanalytical chemistry, mass spectrometry,and CMC services, are excited to announce a strategic partnership. This collaboration will expand both companies’ capabilities to offer comprehensive solutions across the drug development lifecycle, from early-stage research to clinical manufacturing testing and regulatory compliance.

A Synergistic Approach to Drug Development

By combining the deep expertise of Emery Pharma in mass spectrometry, peptide mapping, and analytical chemistry with Marin Biologic Laboratories’ strengths in cell-based assays, immunoassays, gene therapy, and biologics clinical testing, this partnership creates an unparalleled offering for biotechnology, pharmaceutical, and medical device companies. Together, the companies will provide end-to-end services that streamline the complex process of developing both small and large molecules.

Dr. Tania Weiss, CEO of Marin Biologic Laboratories, further added “We are excited to collaborate with Emery Pharma and utilize our unique skills and capabilities to provide exceptional service offerings to Clients. Our combined efforts will create a one-stop shop, whereby we will enhance efficiency and shorten timelines for Clients to bring innovative therapies to clinical testing and market expeditiously.”

Dr. Ron Najafi, CEO of Emery Pharma, said, “This partnership represents a powerful alignment of our capabilities. Our advanced analytical chemistry and regulatory expertise, combined with Marin’s biologics and cell biology proficiency, will accelerate our clients’ journeys to market and offer a robust platform for innovation.”

Expanded Services for Clients

The collaboration will focus on delivering:

• Comprehensive CMC services: Streamlining drug manufacturing and control for biologics and small molecules, ensuring product quality and regulatory compliance.
• Mass spectrometry and peptide mapping: Offering in-depth molecular characterization using Emery Pharma’s innovative mass spectrometry technologies, including high-resolution Orbitrap and LC-MS systems.
• Cell-based assays and biologics testing: Supporting clients with pre-clinical and clinical assay development, drug release, stability studies and clinical PK assay through Marin Biologic Laboratories’ specialized services.
• Regulatory support: Providing critical FDA, GLP, and GMP consulting and ensuring seamless compliance across all phases of drug development.
  
  

Recently, Marin Biologic Laboratories announced the successful completion of our state-of-the-art testing facility in Novato, California, by the U.S. Food and Drug Administration (FDA). The inspection, conducted from July 23 through July 24, 2024, resulted in no 483s and no observations.