Therapeutic Drug Development: What’s this CMC and Why should I think about it early in development?
An area of therapeutic development that needs early and on-going consideration is CMC (Chemistry, Manufacturing, and Controls). At the onset of product development, a manufacturing process needs to be designed and developed to achieve the desired product, accompanied by testing during both in-process and at final product steps to ensure product quality and safety.
During development you will hear mention of development of drug product, analytical methods, stability data, drug substance, product specification(s), in-process control methods – these are all part of the CMC submission which the regulatory bodies will require in order to assess the efficacy, safety and quality of the final product – therefore, it is critical to be thinking and planning about CMC requirements for your product early.
The regulators encourage dialogue early too. Recently at the Cell & Gene Live 2024 Regulatory Outlook webinar with Centre for Biologics Evaluation and Research (CBER) – part of FDA – Dr Peter Marks & Dr Nicole Verdun were discussing the development of new cell & gene therapies and requested biotech & biopharma to have early (and frequent) interactions with the FDA – they gave the example of engaging them during analytical method development rather than going to them with the final method which may have issues not considered by the developer.
The Peritus team offers technical, strategic regulatory and development support services in CMC.
The team has significant industry experience with biologics (recombinant proteins, monoclonal antibodies, vaccines (both therapeutic and prophylactic), biosimilars, ATMPs (cell, gene and tissue therapies) and small molecules.
The depth of expertise and experience within the CMC team enables Peritus to provide bespoke and often innovative approaches to overcome complex issues encountered in product development and challenging of the status quo.
Examples of recent projects:
- Provision of regulatory CMC support for an oncology gene therapy product and various monoclonal antibodies
- Scientific meetings with FDA / EMEA
- MAA preparation for monoclonal antibody products and vaccines (EMA/FDA)
- Orphan biologic (breakthrough therapy); providing early phase regulatory support for scientific advice meetings and IND/IMPD writing
- Post approval lifecycle regulatory support for vaccines and monoclonal antibodies – including site transfers
- Regulatory strategy and TSE risk assessment for a cancer vaccine in early development
- Set strategy for novel product packaging redesign and subsequent over label