Lyophilization and Stabilization of Vaccines

Chesko, James; Fox, Chris; Dutill, Tim; Vedvick, Thomas S.; Reed, Steve

doi:10.1002/9781118023648.ch14

Cited by 2 publications

(1 citation statement)

References 71 publications

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“…The formulation design and correspondingly selected excipient in lyophilized formulations were chosen to study their impact on improving vaccine stability through hydrogen bonding, cryoprotection, beneficial increases in viscosity, preferential exclusion, and behaving as bulking agents while inhibiting aluminum adjuvant agglomeration under freeze-thaw and lyophilization stresses. 16,27,28 Our findings suggested that combinations of viscosity modifiers, cryoprotectants, and disaccharides enabled successful development of a lyophilized multivalent adjuvanted PCV-15 vaccine that may have applicability above and beyond PCV for other adjuvanted or non-adjuvanted vaccines.…”

Section: Introductionmentioning

confidence: 81%

Enabling Lyophilized Pneumococcal Conjugate Vaccines Through Formulation Design and Excipient Selection Suitable for A Multivalent Adjuvanted Vaccine

Mensch¹,

Chintala

Nawrocki³

et al. 2021

Journal of Pharmaceutical Sciences

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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.

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Section: Introductionmentioning

confidence: 81%