Biochemicals & Raw Materials

Performing Quality by Design on hydrolysates: a DOE case study

Hydrolysates provide increased cell growth and titers. The aim of FrieslandCampina Domo is to re-define hydrolysates and re-design their quality profile. The Quality by Design concept as put forward by the FDA proves to be an excellent framework for achieving these goals. In addition it will also enable FrieslandCampina Domo to provide a Design Space of this critical raw material for the biopharmaceutical industry and so making process changes easier and cost effective. FrieslandCampina Domo has analysed protein hydrolysates at…

Albumin: A robust pharmaceutical excipient in the stabilization of protein therapeutics

Optimal formulation of peptide and protein pharmaceuticals into efficacious dosage forms to ensure sufficient stability and provide acceptable shelf life is critical. To achieve a stable pharmaceutical drug product, excipients are often added to the protein drug substance. In this study, we investigate recombinant human albumin (rAlbumin) for its ability to prevent or minimize physical and chemical degradation of two allelic variants of the recombinant malaria vaccine candidate, merozoite surface protein 2 (MSP2), in various test formulations. The studies establish…

Application of animal-free recombinant bioactive protein supplements to improve the performance of cell-based viral vaccine production

The development and regulatory approval of continuous cell lines for manufacturing viral vaccines has brought numerous benefits to production processes. We and others have contributed to upstream advances by improving cell culture media with the development of animal-free and chemically-defined recombinant protein supplements. The supplements developed include recombinant insulin-like growth factor-I (LONG®R3IGF-I), epidermal growth factor (LONG®EGF), transforming growth factor-α (LONG®TGF-α), transferrin (CellPrime™ rTransferrin AF), and albumin (CellPrime ™rAlbumin AF-G or -S). Extensive literature on the action of these bioactive proteins…