SynCo’s philosophy is to ‘plan for success’. This means that we do not simply develop a process that will work at the scale of production required for Phase I clinical trials, but we will focus on your long term strategic goals and plan with these in mind, such as a strict cost of goods target. This essentially means that we will develop a process with the eventual commercial scale in mind and scale-down to fit your early phase clinical requirements. This typically means that the following factors are considered before any production steps are implemented:
• expression of the product (secretion or cytoplasmic production)
• fermentation process and OD targets
• downstream processing, including column resins used (cost and availability)
• formulation and presentation
Some of SynCo’s clients have a well defined and strict Cost Of Goods (COGs) target set early on in product development. One of such clients, PATH, requested SynCo to re-develop an existing commercial process for its conjugate MenA vaccine for Sub-Saharan Africa. As the COGs target was very low ($0.50/dose for mass vaccination), it had to be shown that this was a realistic possibility, even prior to commencing Phase I clinical trials, to make product development worthwhile.
PATH is an international, nonprofit organization that creates sustainable, culturally relevant solutions, enabling communities worldwide to break longstanding cycles of poor health. PATH’s new conjugate Meningitis A vaccine for Sub-Saharan Africa consists of Men A polysaccharide conjugated to a carrier protein. This is in development for use in people in Sub-Saharan Africa, including neonates and is currently in late stage clinical trials.
Due to SynCo’s experience in GMP polysaccharide production, PATH selected SynCo to re-develop a commercially available production process for the polysaccharide component of its Meningitis A vaccine at a much lower COGs. Together with the strict limit on COGs, this project was to be completed to a very tight schedule, with only 8 months for process development and the completion of GMP manufacture at 1100 L-scale.
SynCo met the challenge head-on with an innovative approach for the re-development of the MenA polysaccharide production process, involving both fermentation and downstream purification processes. GMP production was completed on time and material manufactured by SynCo has now been used in all phases of clinical trial. SynCo also successfully managed to keep the price low ($0.02/dose for polysaccharide API) which enabled PATH to meet its price per dose target.
This project was successful due to PATH’s focus on long term goals even in the early stages of the project.
For more information on PATH’s development of a MenA vaccine for Sub-Saharan Africa, please follow this link: http://www.path.org/projects/meningitis_vaccine.php