By Achim Schwämmle, MilliporeSigma, Darmstadt, Germany; Ranjeet Patil, MilliporeSigma, Bedford, MA, USA; and Mikkel Nissum, GSK Vaccines S.r.l. (Siena, Italy)
Vaccines are one of the most cost-effective health interventions available, and demand for safe and affordable vaccines continues to grow, to protect adults and children from numerous bacterial and viral pathogens. However, thanks to the sheer number and diversity of today’s promising vaccine types, and many competing cell culture, production and purification options that are available, development of large-scale vaccine production process remains an inherently challenging undertaking. As a result, the developmental pathway for promising new vaccine candidates is far from assured.
The decisions related to unit operation selection and process design have significant technical and business implications for the success of any vaccine-manufacturing effort through each stage of development and scaleup. Technical decisions related to process development have direct business consequences, in terms of the overall technical and commercial viability of the proposed production route, the required capital, operating costs, critical timeline implications, final per-dose vaccine costs and more.
Vaccine developers should work to develop close partnership with key technology providers to leverage their broad and deep domain expertise and operating experience and to gain access to that partner’s diverse cohort of internal experts (including not only biopharmaceutical scientists and engineers, but modeling and simulation experts, economists, regulatory-review experts and more). Such partnerships between vaccine manufacturers and technology providers can accelerate the development of purpose-built solutions and eliminate process bottlenecks by leveraging the core competencies and insights of each partner.
This white paper showcases collaborative technology-development efforts carried out by the DiViNe consortium to advance the use of an innovative affinity chromatography platform during vaccine manufacturing. This paper also discusses how long-term partnerships with strategic technology experts can help overcome inherent issues that arise as promising vaccine candidates move through scaleup, from proof-of-concept through commercial-scale manufacturing.