- Minaris has enhanced its dedicated GMP cell banking suites at its Philadelphia facility, expanding infrastructure designed to support cell banking and biosafety testing programs.
- The upgraded suites integrate GMP cell banking, characterization testing, and biosafety testing services to support clinical and commercial cell and gene therapy development.
Minaris has announced enhancements to its dedicated GMP cell banking suites at its Philadelphia facility, which serves as a centralized hub for cell banking and biosafety testing. The cell and gene therapy CDMO said the upgrades are intended to strengthen GMP infrastructure, support regulatory compliance, and provide clients with integrated manufacturing and testing services.
The upgraded facility includes multiple dedicated suites designed to support concurrent cell banking programs. According to the company, the clean rooms are aligned with EU GMP Annex 1 and global regulatory standards and feature controlled personnel and material flows, ISO 5 (Grade A) critical zones, and ISO 7 (Grade B) background cleanrooms. The enhancements also include modernized environmental monitoring and expanded quality oversight measures.
Minaris stated that the enhanced suites combine GMP cell banking with characterization and biosafety testing services, including sterility, mycoplasma, viral safety, and identity testing. The company said this integrated approach is intended to simplify the management of Master and Working Cell Banks while providing coordinated project management and timely access to testing data.
“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.”
Dr. Ilya Koltover, President of Minaris Advanced Testing
The company said centralizing cell banking and testing activities in Philadelphia helps synchronize manufacturing, quality, and project management functions. Minaris noted that the enhanced suites support its broader strategy of providing integrated services that help developers prepare cell banks for clinical and commercial manufacturing programs.
