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Karl Heller

Senior Consultant

Karl has 20 years of experience in the Biotech industry, focused on acting as the interface between R&D, tech transfer and cGMP manufacturing.

Karl is an engineer for biotechnology and gained his degree from the University of Applied Sciences in Berlin, Germany.

He joined Bavarian Nordic GmbH in 1997 and established the process and analytical development group for virus-based vaccines and therapeutics in Munich. He was responsible for developing GMP compliant processes and associated analytical methods for Bavarian Nordic’s virus-based vaccine technology and for transferring these technologies to external CMOs. During this tenure he and his team developed the first GMP-compliant manufacturing process for recombinant MVA (Modified Vaccinia Ankara) vaccines and he holds several patents in this area.

In his subsequent role as Head of Production he was responsible for manufacturing multi million doses of a second-generation smallpox vaccine.

In 2003 he was founding his own company VIVACS GmbH, offering services in the field of vaccine design and development, where he developed and established the MVAtorTMplatform technology.

At Emergent Biosolutions Karl as Senior Director Process & Analytical Development was responsible for enhancing Emergent’s platform technology and successfully developed a novel manufacturing process for recombinant viral vaccines introducing cell line and single-use technology

Recently he served as Senior Expert Technical Operations for IDT Biologika, where he acted as Project lead for outsourcing of licensed veterinary products and coordinated tech transfer activities to external CMOs.

In his various positions he had interactions with all major regulatory bodies (e.g. FDA, EMA, PEI, MHRA) as well as several governmental bodies (e.g. ministries in Germany and UK, NIH, BARDA) and NGOs (e.g. Aeras, BMGF, IAVI). 

Karl has a sound understanding of biopharmaceutical processes (process development, analytical development, formulation) within R&D as well as GMP environments.

At Biopharma Excellence, Karl provides scientific as well as regulatory and strategic expertise in CMC-related issues.