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.