Cerebro CMC’s consultants are experts in the technical, operational and quality elements required for the development of small molecule and biological drugs.
We deploy experts with either the breadth of skills to manage whole CMC programmes or with the depth of skills to dive deep into specific disciplines: analytical validation, process development, technology transfer, manufacturing, stability, formulation, quality management systems.
All of our consultants have many years of experience directing contract development and manufacturing organisations, gaining a strong understanding of the regulatory requirements for a successful CMC package.
What our clients say
“Depth of technical knowledge aligned to a strong personal initiative to get things done, whilst at the same time ensuring quality standards and budget constraints are adhered to”
“Technical knowledge and pragmatic style have contributed to the successful completion of an important project milestone”
“Provided thoughtful strategy and strong tactical implementation to deliver our [CMC] objectives”
“A valuable partner in contract negotiation, communication with CMO, interpretation of data and problem solving”
A large pharma company was looking to transfer a wide-ranging portfolio of marketed consumer health products, some medicinal and some food supplements, from in-house GMP manufacture to third-party contract manufacturers. Support included: technical leader for tech transfer team, overseeing product risk analysis and transfer planning; technical resource to perform in-depth CMC health check of existing operations; joint quality leader, managing analytical validations and transfers, and executing a large number of stability studies; on-site support at sending site and receiving sites. The support resulted in successful establishment of GMP operations at the CMOs and valuable data for decision-making on the commercial viability of products within the portfolio.
Early Phase Manufacture
A single asset development company was looking to establish a virtual development team to achieve proof of concept for a novel synthetic peptide. Support included: managing the secondary manufacturing of clinical IMP at CMO; arranging GMP audits of CMOs; coordinating clinical supplies for Phase 2 studies; selecting formulation development partner and overseeing development of an optimised formulation; technical and quality management of long-term stability studies; writing of CMC sections of Investigators’ Brochure and IMPD. As a result, several clinical studies were completed.