Minaris is a global cell and gene therapy (CGT) CDMO and multimodal biosafety testing organization. With more than 25 years of CGT development and manufacturing expertise and more than 40 years in biosafety testing, Minaris combines deep legacy experience with state-of-the-art GMP facilities as a fully U.S.-owned organization under new ownership and management, built for today’s evolving therapeutic landscape. Through its divisions, Minaris Advanced Therapies and Minaris Advanced Testing, the company supports innovators from IND through commercial supply and delivers GMP analytics, biosafety, viral clearance, and product characterization across CGT and biologics. With five global sites across three continents, Minaris is committed to helping partners bring more therapies to more patients worldwide.

Company (Headquarters):

United States

Types of Drugs Manufactured:

Cell & Gene Therapy

CDMO Services:

Drug Substance Manufacturing (API);Drug Product/FDF;Research & Development;Regulatory Services;Analytical Development;Supply Chain Logistics

Therapeutic Area:

Cardiovascular;Central Nervous System;Dermatology;Genito Urinary and Women’s Health;Hematology;Immunology;Musculoskeletal System;Oncology;Platform Technologies;Rare and Genetic Disorders;Wounds and Injuries

Facilities Location:

Europe;North America;South-East Asia

Regulatory Approvals for facilities:

USA – FDA;Europe – EMA or constituent countries;UK – MHRA;GMP;ISO 9001;Japan – MHLW

Manufacturing Technologies:

Sterile Vials