Medical Grade protein reagents from BBI Solutions are manufactured to meet ISO 13485, the internationally recognised quality management standard applicable to medical devices and related services.
CellAdvance® Medical Grade proteins can be used for cell culture and non-therapeutic applications in the GMP production of advanced cell therapies. All products labelled as ‘Medical Grade’ are:
- Animal-derived proteins
- Made for consistency, performance and very low immunogenicity
- Manufactured in facility certified ISO 13485.
- Made to the highest quality for use in GMP cell culture, and in regenerative medicine, medical devices and in vitro diagnostic applications
- EDQM-certified to be free from bovine spongiform encephalopathy (BSE)
- Fully traceable – further testing and information can be provided upon request to support your clinical trial, including certificates of origin