Enabling Lyophilized Pneumococcal Conjugate Vaccines Through Formulation Design and Excipient Selection Suitable for A Multivalent Adjuvanted Vaccine
| Autor: | Christopher D. Mensch, Akhilesh Bhambhani, Denise K. Nawrocki, Ramesh Chintala, Jeffrey T. Blue |
|---|---|
| Rok vydání: | 2021 |
| Předmět: |
Multivalent Vaccine
medicine.medical_treatment Pharmaceutical Science Excipient 02 engineering and technology 030226 pharmacology & pharmacy Pneumococcal Infections Pneumococcal conjugate vaccine Excipients Pneumococcal Vaccines 03 medical and health sciences 0302 clinical medicine medicine Humans Vaccines Combined Vaccines Conjugate business.industry 021001 nanoscience & nanotechnology Virology Vaccine Potency Physical stability 0210 nano-technology business Adjuvant Design space medicine.drug Conjugate |
| Zdroj: | Journal of Pharmaceutical Sciences. 110:97-107 |
| ISSN: | 0022-3549 |
| DOI: | 10.1016/j.xphs.2020.10.038 |
| Popis: | Despite a consistent benefit of existing pneumococcal conjugate vaccine (PCV) on invasive pneumococcal disease and pneumonia across different epidemiological settings a tremendous gap exists towards global PCV coverage. Currently, no lyophilized dosage form exists in the PCV global vaccine marketplace and currently licensed vaccines target some, but not all relevant serotypes of Streptococcus pneumoniae. The development of lyophilized presentations of an adjuvanted multivalent vaccine formulation that aligns with the evolving epidemiological assessment of the pneumococcal disease offers broader coverage with distinct cold chain and thermostability advantages. To make progress towards this goal, we evaluated the feasibility of developing new formulation to enable a lyophilized adjuvanted PCV vaccine containing 15 different serotypes. Our findings successfully demonstrate a formulation design space that enables enhanced physical stability which controls vaccine agglomeration, preserves in-vitro vaccine potency, maintains PCV antigen adsorption, and yields elegant lyophilized cakes with acceptable clinically relevant reconstitution times. This research also demonstrates the benefit of utilizing specific vaccine formulation excipients and the effectiveness of excipient combinations that may be beneficial for other multivalent adjuvant containing vaccines to enable novel lyophilized formulations necessary for improved global vaccine access. |
| Databáze: | OpenAIRE |
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