Guest Blog: Contract Development and Manufacturing Organisations- Why Would You?

contract research (visual dichotomy Grant)

Progenitor Cell Therapy's (PCT) President and chief scientific officer Dr. Robert Pretti spoke on day 2 of the World Stem Cells and Regenerative Medicine Congress about ‘Creating an efficient, robust and cost-effective cell therapy development and commercialization program'. The emphasis was on the strengths of utilizing contract research and manufacturing organizations at the early stages of therapy development and commercialization, especially important within the context of the immature regenerative medicine industry. Dr. Pretti optimistically explained that solutions are forming around the current challenges facing industry and these could be a catalyst for growth, if early stage development projects keep commercialization in mind from the start*.

According to Dr. Pretti the top 5 drivers for change are:

  • Long patient accrual rates for clinical trials
  • Market acceptance and penetration
  • Reimbursement
  • Product delivery to the patient
  • Staffing and training

To aptly deal with all the usual bioprocess challenges facing cell therapy products, upcoming stem cell derived therapies will need to focus on clinical development as a priority followed by non-dilutive financing with input from the best technical expertise across academia and industry. The expertise now available through focused contract development and manufacturing organizations (CDMOs) can help realize the potential of new companies in the area by helping them to stay lean. Using a CDMO such as PCT can reduce a small company's need for heavy investment into expensive facilities and equipment by providing expertise on the following list from Dr. Pretti's presentation*:

  • cGMP/ GLP manufacturing
  • Product, assay and process development
  • Cell & tissue sourcing, banking & processing
  • Distribution and delivery
  • Consulting and regulatory services
  • Commercialization strategies and value engineering

Providing such expertise in this collaborative manner has already resulted in huge cost of goods (COGs) savings for several of PCT's clients to date with savings running into several fold orders of magnitude. Of course as a product matures and approaches peak manufacturing the difference in COGs between in-house and CDMOs become less dramatic. Companies may therefore find in-house manufacturing more cost effective as manufacturing from about two thirds of maximal production capacity. However, the message is loud and clear for the early stages using a CDMO can be hugely beneficial in the short term for COGs and therefore for the future of new cell therapy companies who want to reach peak manufacturing.

*Lists taken from Dr. Robert Pretti's presentation at the World Stem Cells and Regenerative Medicine Congress London 2013.

By Vishal Sharma (UCL)

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