Minaris, a global cell and gene therapy (CGT) contract development and manufacturing organization (CDMO) and biosafety testing provider, announced enhancements to its dedicated GMP cell banking suites at its Philadelphia facility.
The upgraded suites strengthen the company’s position as a centralized hub for cell banking and biosafety testing, providing clients with expanded manufacturing capabilities and integrated characterization testing services to support both clinical and commercial programs.
The specialized clean rooms include multiple dedicated suites designed to support concurrent cell banking projects. The enhanced infrastructure aligns with EU GMP Annex 1 and global regulatory standards and features classified environments with ISO 5 (Grade A) critical zones within ISO 7 (Grade B) background cleanrooms. Additional improvements include modernized environmental monitoring systems, enhanced quality oversight, and established technology transfer processes designed to support program progression from development through commercial manufacturing.
“Cell banking is one of the most important steps in biologics and advanced therapy development, and our clients require a partner that delivers quality, predictability, and regulatory assurance from the outset,” said Dr. Ilya Koltover, President of Minaris Advanced Testing. “Our goal is to make cell banking simpler by bringing dedicated GMP infrastructure, integrated testing and cell line characterization, regular program updates, and expert teams with decades of experience together under one roof.”
The Philadelphia facility combines GMP cell banking services with characterization and biosafety testing, including sterility, mycoplasma, viral safety, and identity testing. By centralizing these capabilities, Minaris aims to streamline project management, improve communication, and provide clients with greater visibility into program progress through daily manufacturing updates and coordinated support.
“Operational rigor is at the core of our GMP environments,” said Dr. Orla Cloak, Chief Executive Officer of Minaris. “These enhanced suites improve efficiency and predictability while maintaining the rigorous standards required for GMP production. With integrated characterization and daily visibility into program progress, we’re helping clients reach key milestones on the path to regulatory-ready cell banks.”
The investment reinforces Minaris’ ongoing commitment to its Philadelphia operations and supports the company’s broader strategy of providing integrated testing, manufacturing, and regulatory support services to cell and gene therapy and biologics developers.
Minaris supports innovators from investigational new drug (IND) development through commercial supply and operates five global sites across three continents through its Minaris Advanced Therapies and Minaris Advanced Testing divisions.
About Minaris Advanced Testing
Minaris Advanced Testing provides multimodality biosafety testing services for cell and gene therapies and biologics, including viral clearance, biosafety testing, product characterization, and GMP analytics to support programs from development through commercial readiness. With a client-first approach, Minaris Advanced Testing delivers efficient, cost-effective testing solutions and a streamlined experience that makes it easier for sponsors to execute studies and advance their programs.
About Minaris
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.
For more information, visit minaris.com.
