Generally, the developmental approach for vaccines is like that of comparable biotherapeutic modalities, requiring developmental activities such as formulation development, analytical development, and extensive characterization, for both drug substance and drug product. For QC release and stability testing, vaccines need assay validation.
With extensive experience across a range of biopharmaceutical modalities, we can support your vaccine development activities, operating to ICH guidelines, ICH Q2(R2) (Validation of analytical procedures); formulation development and ICH Q6B (Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products), to deliver formulation development, characterization, QC release testing and stability testing.
For several vaccine modalities, additional formulation and analytical development requirements need to be addressed for the final drug product. For optimal functionality, vaccine antigens may need to be formulated with specific delivery devices and/or immune enhancing adjuvants.
Generally, vaccine adjuvants fall into two categories:
Both particulate and immunopotentiator adjuvants require specific considerations for formulation development. Adjuvant selection studies, involving assessing specific adjuvants for the desired immune response, represent an early vaccine development activity designed to determine which adjuvant or adjuvant combination delivers the desired immune response.
With particulate and immunopotentiator adjuvants, additional specialized analytic methods may be required for QC release, stability testing and characterization. When selecting analytics for the vaccine drug product, methods that can evaluate both the antigen and adjuvant, along with any potential interaction between the two components, will be needed.
As synthetically derived vaccines, both subunit and mRNA-LNP vaccines require specific formulation requirements. Gain formulation development support for both subunit vaccines and mRNA-LNP vaccines with our extensive experience.
