Category: CMC Development and Manufacturing Consulting
For one of our first clients, Cilatus performed as the external, «Virtual CMC» development, CMC regulatory affairs and quality assurance team. Our US-based, NASDAQ listed client didn’t have any of these functions internally because they wanted to stay lean and wanted to stay focused on their science and clinical development. Therefore, Cilatus carried out all CMC related work for this client for a total of four biologics over a period of 4 years. For each new biological entity we develop fitting CMC development strategies, we searched and selected CMO‘s, we managed the CMO‘s, we oversaw and shaped the cell line, upstream, and downstream process development, we managed analytical development work at contract laboratories, we planned and managed all clinical supplies, we developed SOP‘s and quality systems, we released clinical batches, and we took care of all regulatory CMC work including IND filings, amendments briefing packages. We integrated with our client through the client’s development teams, regular tele/video conferences and face-to-face meetings, and Cilatus leadership stay closely connected with the client leadership team. Through the CMC effort led by Cilatus, one asset was brought from pre-clinical into Phase III, one program was patterned with large Pharma and is currently in Phase II, and two programs were brought into Phase I. References for this work and case study are available on request.