AbtBioConsult ApS was founded in 2018 by owner and CEO Anne B. Tolstrup, PhD. The company is providing Chemistry, Manufacturing, and Control (CMC) consulting services to the biotech and biopharmaceutical industry. This includes technical, regulatory, and strategic consulting services. Specific fields of Biologics expertise include mammalian cell line development, early and late-stage process development, MCB/WCB generation and release, process scale-up and cGMP Manufacturing; Process validation including risk assessments, process characterization, PPQ runs, control strategy and continued process verification (CPV); cGMP Manufacturing documentation requirements; COGs estimates and CMC development timelines; Selection of and program management of CDMO activities including RFP preparation, proposals review, negotiations and selection; regulatory CMC support, authoring of Module 3 sections of INDs and BLAs, technical quality expert support at agency meetings, PAI inspections, technical authority and client audits support; technical due diligences for investors; retro- and lentiviral vector technology expertise.
Anne B. Tolstrup obtained her PhD in molecular and cell biology from University of Aarhus in 1994, followed by a long career in Biotech and Biopharmaceutical companies in Denmark and abroad, where she has held various Leadership positions with focus on Biologics. Since she founded AbtBioConsult in 2018 she has consulted for >30 large, mid-sized and small biotech/biopharma companies on CMC development, regulatory filing and commercialization activities of a wide range of Biologics including monoclonal antibodies, bi-specifics, recombinant proteins, vaccines, and biosimilars, as well as for investors with interests in funding and/or purchasing Biotech companies. She has a very strong knowledge of mammalian cells scientific and industrial usage along with viral vector expertise in gene therapy.
AbtBioConsult services have so far included long-term CMC and regulatory support of Biologics process development and GMP manufacturing for clinical trials and market approval; selection and management of CDMOs; technical audits; investor due diligences; CMC program management; voice-of-customer market analyses; comprehensive CMC strategic analyses for companies moving into the Biologics field; training courses on industrial CMC development and manufacturing of Biologics.