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 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.

CMC Consulting

Alacrita's pharmaceutical development, CMC-regulatory, QA and supply chain experts can help you chart the most efficient course through product development.