CMC consultancy for a company developing a peptide

Challenge

A small biotech company was developing a peptide and needed support in taking the compound to first-in-man studies and Phase II clinical trials. This was the first time the company had taken on a venture of this kind.

Solution

Our CMC consultant joined the virtual team responsible for taking the compound to first-in-man studies. Our support included:

  • advising on drug substance manufacture, characterization and salt selection, developing analytical methods and stability testing
  • helping resolve a number of development issues identified for the drug substance
  • recommending and assessing appropriate chief research and marketing officers for CMC activities including development of assays and stability testing, and reviewing and negotiating contracts and technical agreements
  • creating a formulation strategy for Phase I trials and design of the formulation
  • providing CMC advice and attending two scientific meetings with the MHRA (Medicines and Healthcare Regulatory Agency)
  • helping establish the documentation systems required for both quality and future due diligence
  • providing guidance on the specifications for drug substance and product
  • compiling CMC data for the IMPD  (Investigational Medicinal Product Dossier), which was approved with no questions raised
  • CMC planning for Phase II studies

On the strength of our support, the client retained our CMC consultant for a second development venture, providing similar support in developing a new IV injectable formulation.

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