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Enabling Lyophilized Pneumococcal Conjugate Vaccines Through Formulation Design and Excipient Selection Suitable for
Christopher Mensch1, Ramesh Chintala2, Denise Nawrocki3
1Biologics and Vaccines Analytical, MMD, Merck & Co., Inc., West Point, PA, USA.
Researchers developed a novel lyophilized pneumococcal conjugate vaccine (PCV) formulation with 15 serotypes. This innovation offers improved thermostability and broader coverage, addressing gaps in global vaccine access.
Area of Science:
- Vaccinology
- Pharmaceutical Formulation
- Microbiology
Background:
- Existing pneumococcal conjugate vaccines (PCVs) show consistent benefits but global coverage remains limited.
- A lack of lyophilized PCV formulations hinders wider accessibility and thermostability.
- Current vaccines do not cover all relevant Streptococcus pneumoniae serotypes.
Purpose of the Study:
- To evaluate the feasibility of a new formulation for a lyophilized adjuvanted PCV.
- To develop a vaccine containing 15 different pneumococcal serotypes.
- To enhance vaccine stability and global accessibility.
Main Methods:
- Formulation development for a lyophilized adjuvanted PCV.
- Evaluation of physical stability, antigen adsorption, and in-vitro potency.
- Assessment of lyophilized cake appearance and reconstitution times.
Main Results:
- Demonstrated a viable formulation design space for enhanced physical stability.
- Controlled vaccine agglomeration and preserved in-vitro potency.
- Achieved acceptable reconstitution times and maintained antigen adsorption.
Conclusions:
- Successful development of a stable lyophilized adjuvanted PCV formulation with 15 serotypes.
- Identified beneficial excipients for multivalent adjuvant-containing vaccines.
- This formulation offers potential for improved global vaccine access through enhanced stability.
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