Recognizing that physical stability and conformational integrity is an absolute requirement MassBiologics has significant experience in developing stable formulations for biological products - including high concentration antibody formulations.
When developing a client's formulation, the specifications for the planned dosage form such as route and location of administration, frequency of administration and indication are considered as all of these parameters can impact the acceptable design space for the final formulation.
Excipient screening is performed using reagents that are Generally Recognized as Safe (GRAS) and whenever possible, in amounts not exceeding those that have been used in previously approved therapeutics.
Pre-formulation studies that include accelerated stress studies are performed to identify conditions that destabilize the selected protein and can ultimately lead to loss of stability. Identifying conditions that cause rapid destabilization and/or degradation is useful information that can be leveraged during excipient screening.
Non-GMP accelerated stress studies are performed to select and confirm the final formulation.