AbtBioConsult is providing Chemistry, Manufacturing, and Control (CMC) consulting services to the biopharmaceutical industry. This includes technical, regulatory, and strategic consulting services. Specific fields of expertise includes cell line development, early and late stage process development of biopharmaceutical manufacturing processes, validation of manufacturing processes, hereunder risk assessments, process characterization, PPQ runs, control strategy and continued process verification (CPV), retro- and lentiviral vector technology, selection of CDMOs, management of CDMO programs including development activities and cGMP manufacturing operations, regulatory CMC support, authoring of Module 3 sections of INDs and BLAs, quality expert support at agency meetings, PAI inspections, technical audits and due diligences.
The Owner of AbtBioConsult, Anne B Tolstrup, has consulted for a variety of large, mid-sized and small biotech/biopharma companies on their CMC development and commercialization activities of a wide range of biologic products including monoclonal antibodies, bi-specifics, recombinant proteins, vaccines, and biosimilars. She also has expertise with retro- and lentiviral vectors used in gene therapy and a very strong mammalian cells background. Consulting services have included expert analysis and advice on appropriate expression systems; cell line development including clone selection and clonality assurance; development, scale-up, and validation of biopharmaceutical processes; production and testing of GMP cell banks; selection of CDMOs for outsourcing of early and late-stage CMC development and manufacturing; technical audits; due diligences; CMC program management; voice-of-customer market analyses; comprehensive CMC strategy analyses for companies in the biologics field.
Anne Bondgaard Tolstrup
Lille Sverige Vej 7 A, 3400 Hillerød, Denmark
Mobile phone: +45 25663065