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CMC Solutions

Our CMC experts can oversee, manage or support the entire - or part of the - production supply chain from drug substance starting materials to delivery and administration of medication at the clinical site.

The CMC team at 2 Bridge consists of experts in multiple domains of CMC, all passionate and motivated to contribute to the success of our Tiger Teams. Our team has a joint track record in managing all aspects of CMC covering the preclinical phase up to late-stage clinical development, registration, and post-approval life-cycle management.

CMC Solutions

CMC Development Oversight

Quality Target Product Profile development based on Target Product Profile

Drug substance

  • Small/large molecules
  • ASOs/SiRNA
  • ATMPs
  • Peptides

Drug product

  • Oral delivery
  • Parenteral delivery (SC, IV, intrathecal,..)
  • (Trans)dermal delivery
  • Nasal delivery

Clinical supply management

  • Packaging & labeling
  • Blinding/randomization
  • Comparator sourcing/ shipment/storage
  • Compatibility studies
  • Pharmacy manual preparation

Regulatory CMC

  • CMC development strategy
  • Briefing book
  • Response to questions

GMP Quality oversight

Management of all CMC-related activities from preclinical phase to late phase development including but not limited to:

Vendor selection / management
Analytical development / validation
Impurity management
Formulation development / process development
Stability studies
Set-up and shelf-life management
Scientific & Regulatory writing
PPQ prep / mgt / quality & scientific risk management

Emilyne Blattes

R&D Leader, Scientific Development & CMC

A rigorous and methodical biochemist with solid analytical and CMC skills and over ten years of experience in scientific research. Highly interested in regulatory strategy, has a global view on pharmaceutical project development.

My work/involvement in a project often starts by performing a project gap assessment, which often reveals the tip of the iceberg called “challenges” and helps to reflect on the major project hurdles. It also obliges you to have a global view of combining the bricks of the puzzle into one single big piece. CMC is regarded as the least important point by most of our academic clients. But it involves the tested product that will provide the right pharmacodynamic effect in a human being. It’s what you aim for! You need the right amount of formulated products that fulfill regulatory requirements of the required quality and characterization level from the right API of satisfying purity. Only with this single sentence, I can already involve 4-5 of my colleagues having expertise in quality, analytics, formulation, regulatory, and activities oversight.

CMC is often underestimated when it has a major project impact, I like to remind colleagues/clients of that!