Media – Reagents – Buffer

PAN-Biotech is a leading specialist in the production of sterile liquids for bioproduction, pharmaceutical applications and cell culture.

Our product portfolio includes cell culture media, supplements and essential buffer solutions designed for research, industrial and clinical applications. We provide WFI quality water and other critical reagents for cell expansion and purification in industrial processes.

Our core strength is flexibility, enabling us to offer customized solutions to partners in both, research and industry. This includes state-of-the-art cell culture products in research and preclinical settings, all manufactured according to ISO 13485 standards. For clinical applications, we facilitate a seamless transition from RUO to EU GMP Annex 1, supporting easy access to commercialization.

The development of a therapy application is complex:
It begins as an idea in research and development and goes through preclinical and clinical studies until market approval and commercialization are achieved.

During this process the shift from RUO to GMP is a quality necessity but it is difficult to modify key parameters like raw materials when a documented process has already been established. Therefore it is advisable to switch as early as possible to optimize costs and save valuable time. This transition is crucial for ensuring product safety and efficacy, meeting regulatory requirements, and ultimately, securing market approval.

We support you during the development from research to commercialization with our culture media, reagents and buffer solutions, which support a seamless transition with three perfectly tuned quality grades.

Our products play a crucial role in various life science applications, including Advanced Therapy Medicinal Products (ATMPs), Biopharmaceuticals, Gene and Cell Therapies, Vaccine Production, and more.

Whether you need culture media for cell therapy purposes, reagents or buffers for bioprocessing, we deliver ready-to-use solutions for your GMP applications.

These products are manufactured in our new GMP compliant production facility under stringent quality control.

Our new production facility, open since 2022, was built and qualified according to EU GMP Annex 1 for sterile medicinal products. Its state-of-the-art design allows rapid, flexible and scalable production of your products in GMP quality, performed by our qualified and highly trained personnel.

• Dedicated animal component free facility
• Class D to A cleanrooms
• 1,000,000 L filling capacity per year
• Lot sizes up to 1,000 L
• Sterile filling from 50 ml vials to 1000 L Bags
• Single-use equipment
• Environmental monitoring according to GMP guidelines
• Established processes for customized productions