Focus on Cost of Goods During Process Development


Posted: 14/10/2010

SynCo’s philosophy is to ‘Trust us to make it right’. We will 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. We will therefore 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 our clients, PATH, requested SynCo to re-develop an existing commercial process for its conjugate Meningitis A (Men A) 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 Men A vaccine for Sub-Saharan Africa consists of Men A polysaccharide conjugated to a carrier protein. 

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 Men 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 for a phase-I clinical trial. Thereafter the phase-II and phase-III material was produced and the process validation batches. 

SynCo met the challenge head-on with an innovative approach for the re-development of the Men A 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 trials.  SynCo also successfully managed to keep the price low which enabled PATH to meet its price per dose target. 

The vaccine is currently been administered in Africa and the development and scale-up were successfully complete by SynCo in the course of the program. 

For more information on PATH’s development of a MenA vaccine for Sub-Saharan Africa, please follow this link:
http://www.path.org/menafrivac/index.php