Wolfgang Berthold, Ph.D., Founder of Berthold BioPharm consulting GmbH in Switzerland was until recently Chief Technology Officer and SVP Technical Development, and member of the Board (Geschäftsführer) of Biogen Idec International GmbH located in Zug, Switzerland with assignments for strategic international interests of the company including biosimilars.
From 2004 to 2008 he was heading the Technical Development of Biogenidec Inc. (BIIB) with departments in several international sites (US and Europe). He had joined Idec in 2000 in San Diego as Head of Bio Pharmaceutical Manufacturing and took responsibility for Manufacturing Operations, Process Development and Facilities & Engineering until shortly after the IDEC's merger with Biogen in 2003. To IDEC he had come from Hoffmann LaRoche, Nutley NJ where he had lead the Biotechnology Manufacturing and Development for 5 years. At Boehringer Ingelheim in Biberach, Germany he had spent 16 years in biological and biotech Reseach and Development starting in 1979.

During his long career in biotech, Dr Berthold has worked with numerous protein drug candidates, some succeeded in the clinic and he brought them to markets in the US and Europe. Since 1975 he has worked on interferons, different one`s in different jobs (IFN alpha-Roferon, IFN beta Avonex and IFN gamma-Imukin^®) promoting their use for human health. At Roche he started to pursue PEGylation to modify proteins for long half lifes and developed the PEG-Roferon to the point of submission. As PEGASYS, it was approved in 2002 and became a great commercial success.
A core interest has been his engagement in the development of Antibodies –sometimes about 40% of all candidates in development. At BIIB he supported the launch and relaunch of Tysabri, an antibody for a revolutionary treatment of Multiple Sclerosis (2006 in USA and later EU). At Roche he set up the production of Zenapax (1998)(for trans-plantation) the second approved therapeutic antibody (one month after Rituxan from IDEC & Genentech) and at IDEC, it was Zevalin, (2002 for Non Hodgkin Lymphoma) in form of a 'magic bullet' in a kit as an 90Yttrium carrying antibody for radio-immunotherapy.

When in charge of biotech process development at Boehringer-Ingelheim (1979 -1995) he developed Actilyse, together with Genentech in a Joint Venture. This was the first recombinant product manufactured by mammalian cell culture at large scale i.e. in bioreactors of 12,000 L. This size of operation based on recombinant cells had sparked hot debates in Germany about the perceived risks of genetic engineered organisms. Dr. Berthold could mediate successfully in this emotional and political debate helping Actilyse to find approval in the European market in 1987.

Dr. Berthold has lead the building of 2 large scale ('6-pack') manufacturing facilities. In the first "6-pack" in Boehringer Ingelheim, 1984-7 the first in this scale in Europe, he was responsible for all processes and analytics; and in the 2nd one for IDEC in San Diego 2000-4 as overall Manager. This plant is now operated by Genentech/Roche.

He has held numerous leadership positions in professional pharmaceutical and Biotech societies in the United States and Europe including PhRMA in the USA and EFPIA in the EU, as well as in the International Committee for Harmonization (ICH) biotech working group for biotech guidelines in the early 90's. He has served the WHO as expert advisor for interferons assays and standardization. In recent years Wolf Berthold was a well sought after international key note speaker for all aspects of in CMC activities required to bring biologics to market approval including plant design and biosimilars.

Dr. Berthold received his Ph.D. in biochemistry from the University of London, UK, in 1975 after undergraduate studies in Medicine and Biochemistry in Hamburg and Tübingen, Germany. He holds German and US citizenship.