Inclusion of human plasma or plasma-derived proteins in cell culture systems produce media with acceptable performance at small scale. However, scale up to clinical manufacturing proves to be more difficult. Most often plasma or plasma-derived components need to be screened prior inclusion in manufacturing processes as these raw materials often induce unacceptable variability in the final cell product. These variabilities often manifest in unexpected cell or cell product yield or unwanted drifts in the expected phenotype or function of cell or cell-based products. Further, the inclusion of human plasma or plasma-derived components introduces the risk of contamination from adventitious agents.
In collaboration with InVitria’s media formulation specialists, we will formulate a custom blood-free complete media formulation that is designed to be consistent, defined and recombinant – throughout your manufacturing process and methods. Leveraging InVItria’s experience and proprietary media formulations, we can help you produce a product that meets both your quality, production, and performance requirements.
Let us help you engineer the variability out of your media.
- Transparent formulation development process
- Options available to unblind and own the final formulation
- Streamline the regulatory approval process by removing human blood derived components
- Facilitate research and development by chemically defining your cell culture environment
InVitria utilizes advanced design of experiments (DOE)-based approaches to build blood-free formulations around recombinant human transferrin (Optiferrin) and recombinant human albumin (Cellastim, Cellastim S, Optibumin). Clients have the option to either transfer cells and manufacturing protocols to InVitria for media development by InVitria or to have InVitria forward media candidates to the client’s lab for performance assessment inhouse. InVitria will provide candidate final products for final assessment prior to technical transfer of formulations to large scale cGMP manufacturing.
- 6 dedicated scientists, 4 Ph.D. level
- Collectively 40 years’ experience in recombinant protein expression, purification, and media formulation
- Proven success in multiple areas of industrial and therapeutic cell culture including mesenchymal stem cells, T cells, VERO, and other primary cell types
- Experienced in tech transfer and scale up of blood-free media formulations