Welcome to AbtBioConsult ApS

Expert CMC advice and consultancy services on biopharmaceutical products such as antibodies, multispecifics, cell and gene therapy products

Expert services

AbtBioConsult ApS is providing Chemistry, Manufacturing, and Control (CMC) consulting services to the biopharmaceutical and biotech industry. This includes strategic, technical and regulatory services based on her more than 25 years of experience in the biopharma and biotech industry.

01 Strategic Advice and Due Diligence

Organizational setup, costs and timelines for biotherapeutics development.
Technical due diligences and advice on biotherapeutics and biotech company investment and acquisitions.

02 CMC development and manufacturing

All aspects of biologics CMC development and manufacturing from the pre-clinical stage, through scale-up and validation and onto market production.

03 CDMO support

CDMO selection and practical interaction as technical expert or program manager according to client needs. Day-to-day support, data review, troubleshooting, report writing and review.

04 CMC Regulatory

Preparation of Module 3 IND/IMPD and BLA/MAA applications for biotherapeutics, technical audits, agency scientific quality advice and audit support.

05 Intellectual Property

Expert Witness service in intellectual property cases; review and advice on novel IP applications