Bivalent Recombinant Protein Vaccine

A Technical Lead managed a team of formulation development and analytical development experts with the goal of optimizing the final formulation of a bivalent recombinant vaccine. The team met with the client in weekly teleconferences to review progress and determine next steps for the program.

The team succeeded at on-time delivery of an optimized final formulation for the adjuvanted vaccine.

The team created a study plan that combined key studies and development elements into a scope of work. At the end of the project, the client had a complete picture for each of their antigens as well as the bivalent vaccine.

The scope of work included:

• Performing preformulation studies to evaluate the biophysical and chemical stability of each antigen.
• Optimizing conditions for antigen adsorption to adjuvant through designed Binding Studies.
• Performing Formulation Development studies to evaluate the effect of different monovalent and bivalent formulations on antigen stability and adjuvant binding.
• Developing and qualifying Analytical Methods used for release testing to assess and characterize the individual antigens and the bivalent adjuvanted vaccine.
• Performing Forced Degradation studies to elucidate degradation pathways and establish various analytical methods as stability-indicating.
• Performing Container/Closure studies to evaluate the impact of two different container/closure systems on the stability of each antigen.
• Performing Real-time and Accelerated Stability studies

Once the work was completed, our technical team, under the direction of the Technical Lead, transferred the newly developed formulation process and qualified analytical methods to a fill/finish contractor on behalf of the client.