Science and Technologies

• Cell and Molecular Biology (IFN Assay, Messenger RNA translation, cloning).
• Immunology (Killer cell activation, and tumor reduction, Hybridoma, Monoclonals, Sandwich ELISA assays).
• Protein purification (preparative Chromatography, UF & MF filtration, Harvest technologies for manufacture of proteins at very low and very high titers).
• Pharmaceutical Development (Protein formulation and Final product for storage.
  and shipment, Medical devices (Autoinjectors)).
• Analytical methods for Protein characterization (ELISA, Quality control, Stability indicating Tests).
• Process design for pharmaceutical grade proteins.
• Biotech Manufacturing Facilities (design and construction, validation and approval
  up to 6x 15,000L bioreactors).

Selected topics from international presentations
and key notes

• Biotech and process and facility economics.
• Cost evaluations in process development and commercial manufacturing.
• Process Development of biological versus small molecule drug candidates.
• Process design for API with analytical monitoring, validation and PAT.
• Dosage Form Development with protein formulation and Fill&Finish, Autoinjectors.
• GMP Manufacturing at different Scales, Documentation.
• Facility design for biotech plants from 1980 and novel features in the future (SUB).
• Regulatory guidances and approval process (FDA, EMEA).
• Quality systems, QC QA and vendor qualification.
• Complex Biotech drugs approved:
• Interferons, cytokines
• Enzem tPA (Actilyse/Activase)
• Monoclonals, Analytical, Therapeutic, Radio-immuno-therapeutic kit.
• Perceived risk of recombinant DNA and its products.

Contacts in Industry and Biotech ventures

Wolf Berthold entertains excellent contacts in the global community of Biomanufacturing eg with some of the major players in Bioparmaceutics like Genentech-Roche, Boehringer Ingelheim, Biogen Idec, Pfizer-Wyeth, Johnson & Johnson, Merck Serono, MSD Schering Plough, GSK and Novartis. He also has good connections to well known Venture Capital working in the biotech space like MPM, Clarusventure, Venrock, Bayciticapital, Asset Management, TVM, LSP, HBM and others in the East and West
Coast of the USA and in the EU. He has also been invited to serve on some biotech company boards.
For projects requiring additional or different areas of expertise Wolf will also welcome to cover the full requested range comprehensively in a team with other experts, be it as individual contributors or consultancy organisations from his extensive network in the industry.