IND Enabling Supply
Prior to filing an IND, production of small quantities (typically <1Kg) of pure drug substance that is representative of the manufacturing process is necessary to generate frontline safety data to support clinical batches. The drug substance should be prepared to avoid known hazards and be well characterized possessing an attainable purity and impurity profile. Proper CMC planning and cooperative understanding is critical to minimize the technical risks and produce a drug substance product suitable for toxicology studies. Regis’ Project Management Team understands the CMC needs of drug substances at all stages for development and, at the preclinical stage of development, timing is critical. A successful relationship between sponsor and CDMO must be able to work together rapidly using cost-effective strategies to deliver in a timely fashion.
Process Chemistry Team
Regis’ Process Chemistry team has a proven track record of delivering preclinical supplies on time and on budget. Our Project Teams will evaluate the chemistry and work with you to build a plan tailored to your program and within your budget. Even before a contract is signed, our experts will thoroughly review available technical data for technical capability, process safety, potency, and time. Our proposals are built on collaboration to remain focused on the project’s needs all the while offering insights for a robust and pharmaceutically appropriate process easily transferred to Regis’ CGMP facility.
Analytical Development Team
Throughout the project, Regis’ Analytical Development team is in constant contact to ensure effective monitoring strategies are applied using advanced analytical techniques. Analytical chemists are assigned to projects at the very beginning and work together with Process Chemists to enable effective decision making. All the while, experts in the various spaces are developing methods to fully characterize the API. Experts in techniques such as HPLC, LC/MS, LC/HRMS, NMR and other various spectral analyses and chromatographic assays reside at one location allowing for rapid response to chemical challenge encountered.
Typical Pre-Clinical Development Project Milestones
- Project Team Kickoff (Internal & External)
- Potency / banding assignment
- Process hazard analysis
- Process Familiarization
- Control Strategy
- Process Development
- Lab Confirmation batch
- Batch Records Preparation
- Process Demonstration Batch
After or often in parallel with pre-clinical efforts, Regis prepares for CGMP Clinical Supply and Scale up.