June 12 – 17, 2022
Successful development, commercialization and life cycle management of a vaccine drug product represents a significant challenge. For effective, broad-strain pathogen coverage, an antibacterial vaccine often contains multiple antigens formulated at low concentration in the presence of an adjuvant. Due to the complex nature of a vaccine drug product formulation, understanding how manufacturing, packaging, shipping, and storage temperature impacts the underlying physicochemical properties of the drug product is critical. Due to the complexity of the human immune system, if chemical or physical changes occur, comprehending how these changes impact clinical efficacy can be daunting. Therefore, efforts should be directed toward ensuring chemical, physical, and colloidal stability and design of a drug product formulation that has a scalable and robust process early in the preclinical space that can be successful throughout clinical operations and eventually in the commercial phase of the program. As one strives to supply vaccines to developing and emerging markets, increasing focus should be directed to ensuring not only a robust manufacturing process but enhanced thermal stability of a vaccine drug product.
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William Smith, "Development of a pneumococcal conjugate vaccine drug product: Ensuring stability, a robust manufacturing process and long-term commercial sustainability" in "Vaccine Technology VIII", Tarit Mukhopadhyay, Merck Research Laboratories, USA; Charles Lutsch, Sanofi Pasteur, France; Linda Hwee-Lin Lua, University of Queensland, Australia; Francesc Godia, Universitat Autònoma de Barcelona, Spain Eds, ECI Symposium Series, (2022). https://dc.engconfintl.org/vaccine_viii/38