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

Strategic advice

  • Biologics development and manufacturing requirements including organizational needs
  • Biopharma support during portfolio expansion from small molecules to biologics
  • CMC cost-of-goods
  • Advice and technical support of investment banks or biopharma clients
  • Mentoring and training of management and technical staff

Due diligence

  • Technical due diligence on investments in biotech companies or start-ups
  • Technical due diligence on in-licensing of biopharmaceutical product candidates

02 CMC development and manufacturing

Biologics pre-clinical and clinical development

  • Cell line development including clonality documentation
  • Pre-clinical process development of biopharmaceutical manufacturing processes (fed batch and perfusion)
  • Process optimizations during clinical development
  • Genetic characterization
  • Technical CMC support and advise on gene therapy projects including AAV, retro- and lentiviral vector technology
  • Technical CMC support and advise on cell therapy projects

GMP manufacturing

  • GMP Master and Working Cell Bank Manufacturing
  • GMP cell banks characterization
  • GMP Drug Substance Manufacturing
  • GMP Drug Product Manufacturing

Process validation

  • Advice on QTPP and CQA determination
  • Risk assessments
  • Process characterization
  • PPQ runs
  • Process control strategy design
  • Continued process verification (CPV)

03 CDMO support

Sponsor advice and support

  • Request for proposal preparation, proposals review and comparison, CDMO selection
  • Expert support of CDMO pre-clinical and clinical CMC programs
  • CDMO Program management

CDMOs and service providers advice and support

  • Biologics expert advice for service providers including CDMOs, equipment and upstream raw material suppliers
  • Industry needs of raw materials, equipment, analytical methods etc
  • Service provider surveys

04 CMC Regulatory

Documentation and support

  • CMC regulatory support including authoring of Module 3 sections of INDs and BLAs
  • CMC expert support on agency scientific advice, agency filing meetings and Q&As
  • Technical support of PAI inspections and audits

05 Intellectual Property

Patent Evaluation and Support

  • Patent reviews
  • Expert witness support