BPC Arnold GmbH BioPharma Consulting was founded by Dr Stefan Arnold in April 2014 to provide individual support in CMC development and project management for bio-pharmaceutical industry as well as BioProcess platform companies. Special expertise is biosimilar development.
In-depth expertise in biopharmaceutical development enables individual project valuation for a proper portfolio selection and implementation.
Dr. Stefan Arnold is biochemist with 23 years professional experience in biopharmaceutical, bioprocess and diagnostics industries in different executive positions where he set up or optimized various organisations or functional divisions. As co-founder of the first dedicated European Biosimilars company BioGeneriX AG, he acted as project manager for several biosimilar and biobetter medicinal products and lead four thereof to an EMA-approval. Actually he operates as principal consultant supporting international biopharmaceutical and bioprocess platform provider industries in development of drug substance and drug product (mABs, cytokines, biosimilars, ADCs), analysing market and portfolio strategy and implementation of the developments.
- 4 years consultancy for biopharmaceutical and BioProcess industry (mABs, Cytokines, Biosimilars, ADCs, chromatography resins and membrane chromatographie, bioprocess-hardware design)
- 2.5 years CSO at biopharmaceutical platform provider
- 23 years managerial experience in biopharmaceutical and diagnostic industries
- 5 process patents/applications with blockbuster biopharmaceuticals (EPO, IFN-beta, FSH, HTS chromatography platform technology)
CMC project management of 5+ projects (Biosimilars, 2nd generation biopharmaceuticals, cytokines, hormones, monoclonal antibodiesthereof 4 already EMA licensed)
- Type II variation of blockbuster biopharmaceutical downstream process
- Member of the industrial advisory boards for biotechnology of the University of Applied Science Mannheim and for Life Science Management at HTW University Berlin
• Scientific background
• Analytical comprehension
Profile of Services:
Biopharmaceutical development (focus on CMC)
Trouble shooting in development and manufacture
Planning and conduction of comparability exercise
Project valuation for portfolio selection
Interim project management up to clinical phase I
Consultancy for BioProcess Downstream platform technologies
Networking with relevant CMOs, CDMOs and CROs
Confidential list on request
BPC Arnold GmbH