Marco Comby

Background

About Marco Comby

Versatile downstream processing engineer with more than 19 years of experience in early-phase biopharmaceutical process development, specializing in protein purification (DARPins, scFv, scDb, PEG-scFv, mAb), process optimization, scale-up, and technology transfer into GMP production. Additional expertise includes plant-based natural product isolation and formulation into drug delivery systems for medical device applications.Responsibilities in DSP and CMC Project ManagementDSP Process Development and Manufacturing- Conduct in-house downstream process (DSP) development activities, including technology transfers to GMP vendors- Manufacture in-house material for DSP development and preclinical studies- Contribute to the evaluation and selection of GMP vendors involved in DSP manufacturing.Technology Transfer and Production Support- Organize, coordinate, and communicate to support technology transfer to contract manufacturing organizations (CMOs)- Provide on-site support during pilot and large-scale production campaigns (person-in-plant)- Review and approve master batch records and related GMP documentation (e.g, deviations, change requests).Documentation and Reporting- Write development reports and other relevant documents (e.g, memos, risk assessments)- Maintain oversight of manufacturing documentation- Support the IMPD/IND submission process.Drug Product Manufacturing and Supply Chain- Organize and coordinate drug product manufacturing activities performed by CMOs- Manage external activities related to investigational medicinal product (IMP) labeling and packaging- Coordinate material supply for GLP toxicology studies, comparability studies (Tox vs. GMP material), forced degradation studies, and Phase 1/2a clinical trials- Support drug product manufacturing and stability studies; advise on timelines and required quantities for clinical administration.Clinical Trial Support- Organize and manage study drug supply information to support clinical trials- Assist hospital pharmacies with IMP handling for clinical trial execution- Contribute to CMC batch release for use in clinical trials.CMC Project Management- Act as CMC lead and manage assigned CMC projects- Request and review quotes for GMP manufacturing and drug product filling activities- Manage the CMC-specific project budget- Coordinate GMP activities including master cell bank production, engineering runs, GMP drug substance and reference standard manufacturing, and release testing.