Quality driven ISO 13485:2016 certified biosolutions manufacturer of leading bioproduction tools and services used to facilitate basic and applied research and drive the commercialization of new cell and gene therapies
cGMP BioSolutions Manufacturing
CaseBioscience is a high quality ISO 13485:2016 Certified biosolutions manufacturer of leading bioproduction tools and services to facilitate basic and applied research and drive the commercialization of new cell and gene therapies
Our experience going back 20 years has enabled our team to repeatedly execute complex manufacturing and logistics of personalized and highly regulated biologics products.
Our Commitment to You
Supporting the advancing fields of cell and gene therapy
The growth of the biologics market has created an unprecedented demand for cell culture medium.
CaseBioscience will work to continuously meet demand for new, proprietary or customized solutions to support basic and applied research through to commercialization.
Media Development & Optimization
We can cater to your research, preclinical or clinical work regardless of batch size. Save time and costs. Access over 20 years of knowledge and expertise in media development and manufacturing.
Use our Express Media Service for flexible, small-batch production of media prototypes.
Stability and Shelf-Life Testing
Offering a suite of QC testing to ensure batch to batch consistency.
Rigorous quality control standards
cGMP refers to the Current Good Manufacturing Practice regulations enforced by the US Food and Drug Administration (FDA). It is a system put in place to ensure the proper design, monitoring and control of manufacturing processes and facilities.
Our cGMP biosolutions manufacturing facilities adhere strictly to GMP guidelines for each step of the manufacturing practice from initial development to final quality control (QC) release. This ensures we are able to consistently deliver high quality products.
Every batch meets USP <71> sterility & USP <85> Endotoxin testing standards of cGMP manufacturing.
Our research and development team will help you develop custom formulations for your research or clinical applications.