Chemistry, Manufacturing & Controls (API and Drug Product)
NGT BioPharma Consultants’ Chemistry, Manufacturing & Controls (CMC) services support both small molecules and biologics (Mabs, duobodies, proteins, cell therapy, gene therapy as well as new modalities), API, analytical, and drug product disciplines while recognizing that their relevance varies depending on a project’s stage of development. Our experience and expertise can be applied as early as late-stage discovery and spans preclinical and clinical drug development, registration, commercialization, and life-cycle management. NGT’s CMC efforts, which closely align with Nonclinical, Clinical, Regulatory, and Quality/Compliance activities, include but are not limited to the following:
EARLY-STAGE DEVELOPMENT
- Pharmaceutical “developability” assessment and optimization of lead compounds
- Physico-chemical characterization of new chemical entities (NCEs)
- Pharmaceutical development strategy (API, analytical, drug product, clinical supply)
- Fit-for-purpose API synthesis and formulation (oral, iv, fixed-dose combinations) development
- Analytical methods development
- Ensure Quality Target Product Profile achieves desired Target Product Profile
- CMC information for IND/CTA and European IMPD applications
- Select and/or qualify CDMO’s and CRO’s; coordinate and provide oversight
LATE-STAGE DEVELOPMENT
- Pharmaceutical development strategy for pivotal clinical studies and commercial manufacturing
- Select and/or qualify CDMO’s and CRO’s; coordinate and provide oversight
- Clinical supplies for pivotal studies, including strategies for using comparator drugs
- Commercial API synthesis, formulation, and process development
- Analytical control strategies for commercial product, storage conditions, and shelf life
- Scale-up and building of commercial supply chain; achieving launch readiness
- CMC information for NDA, BLA, and MAA submissions, and other regulatory submissions worldwide
- Strategies for life-cycle management: cost optimizations; supporting new indications, new dosage forms and formulations
Although NGT is neither a laboratory or manufacturing services provider, we can serve as your single point of contact to our network of reputable CRO’s and CDMO’s.
