Minaris Enhances GMP Cell Banking Suites At Philadelphia Facility
With new upgraded suites, Minaris provides a complete offering from GMP cell banking to integrated characterization testing supporting clinical and commercial programs
Philadelphia, PA – Minaris, a global cell and gene therapy (CGT) CDMO and multimodal biosafety testing organization, today announced the enhancement of its dedicated GMP cell banking suites at its Philadelphia facility, a centralized hub for cell banking and biosafety testing. The upgraded facilities underscore Minaris’ commitment to robust GMP infrastructure, regulatory rigor, and a more integrated client experience, enabling Minaris Advanced Testing to offer clients seamless access to expanded manufacturing capabilities. By combining dedicated cell banking suites with characterization testing, daily process updates, and deep technical expertise, Minaris provides a scalable, compliant service that helps clients move their clinical and commercial programs forward with confidence.
The specialized clean rooms feature multiple dedicated suites designed for concurrent cell banking programs, with infrastructure and workflows aligned with EU GMP Annex 1 and global regulatory standards. The suites incorporate controlled personnel and material flow, optimized cleanroom processes and classified environments including ISO 5 (Grade A) critical zones within ISO 7 (Grade B) background cleanrooms. It also brings modernized environmental monitoring and enhanced quality oversight to strengthen contamination control, supported by established tech transfer processes that help programs transition smoothly from development through commercial supply.
“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, 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 enhancement reinforces Minaris Advanced Testing’s integrated model by uniting GMP cell banking with regulatory-aligned characterization and biosafety testing in a single U.S.-based hub. These capabilities, including sterility, mycoplasma, viral safety, and identity testing, simplify the management of Master and Working Cell Banks while providing clients with timely data and coordinated project management.
By centralizing banking and testing in Philadelphia, Minaris Advanced Testing reduces complexity for developers by synchronizing manufacturing, quality, and project management. Each program benefits from dedicated support and transparent communication, including daily manufacturing updates that help clients track progress, plan next steps, and make informed decisions.
“Operational rigor is at the core of our GMP environments,” said Dr. Orla Cloak, Chief Executive Officer, 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 enhanced suites further strengthen Minaris Advanced Testing’s cell banking offering while demonstrating Minaris’ continued commitment to its Philadelphia site as a centralized hub for testing and cell banking. By combining GMP infrastructure, integrated testing services, and long-standing technical expertise, Minaris supports a right-first-time approach that helps reduce risk, keep programs on track, and prepare developers for key clinical and commercial manufacturing milestones.
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 or follow us on LinkedIn.