Keynotes Lectures

HIC/DSP Bioseparation Conference


Roman Necina, Ph.D.
Roman is heading the Process Science and Technical Services team at Takeda.
In his current role he is responsible for all process, assay and formulation development activities across all modalities, medical device development, QbD and technical support for GMP products across the internal and external manufacturing network.

Roman has 25 years experience in development and launch of biopharmaceuticals and has served as VP Biopharmaceutical Production & Process Science for Boehringer Ingelheim, SVP Quality & Regulatory Compliance and as VP Technical Operations for Intercell. Roman graduated at the University for Agriculture in Vienna, Austria and holds a Ph.D. in biotechnology.

>> Complex biopharmaceuticals drive implementation of novel and smart technologies

During the last years process development for biopharmaceuticals has been significantly accelerated and de-risked, e.g. by platform approaches and high-throughput systems.

The next generation of biomolecules is more complex and requires new approaches for rapid product development and global commercial supply.
Future market and regulatory pressures can‘t be met with current strategies and solutions.
Novel technologies and manufacturing equipment, automated online assays and data science must already be applied during early development stages.

Klaus Graumann, Ph.D.
Phoenestra GmbH
Klaus Graumann studied Food- and Biotechnology at the University of Life Sciences and Renewable Resources (BOKU) in Vienna, Austria.
After earning his PhD in the group of Prof. Alois Jungbauer, he started a career in the biopharmaceutical industry.

Following a role in GMP manufacturing at Boehringer Ingelheim (Vienna), he moved to Novartis where he had different responsibilities within local and then global technical development functions. Most recently, Klaus was responsible for the late-stage Technical Development organization within the Biologics organization of Novartis.

In July 2018, Klaus joined Phoenestra GmbH as designated CEO and co-founder, a start-up in the induced pluripotent stem cell field. In addition, he is also active as an independent biotech consultant.

>> Trends in development and manufacturing in the biopharma industry

Biologics have revolutionized medicine in many areas over the past decades and reached about 30% of the total revenue of the Pharma industry. Also, the way, how products are developed and manufactured for clinical and commercial use has been changing.

This presentation will analyze the current megatrends in the industry and look at different approaches companies are taking.

Several companies embrace flexible and continuous manufacturing concepts - others invest heavily into high-volume stainless-steel plants.
On the development side, technical development of early pipeline candidates has been highly optimized recently and the focus is now “to fail early”. Besides this critical look at the status quo, an outlook to the next steps in this journey will be given.

Dr. Stefan Hepbildikler
Roche Diagnostics GmbH
Stefan Hepbildikler holds a PhD in biochemistry from the University of Bonn, Germany.
He is following a career at Roche Pharmaceuticals in Penzberg, Germany, in the Bioprocess Development department since 16 years. After ten years in Purification development he recently transitioned to a new role focusing on Bioprocess technology development.

In this role, Stefan facilitates next generation Bioprocessing at Roche Genentech including technologies for purification of biomolecules. He is co-inventor of several patents, co-authored scientific articles, and contributed to several conferences over the years as a speaker and chairperson.

>> When Pipeline meets Platform: Innovation in Bioprocess Development

New therapeutic modalities are designed to address unmet medical needs and increase efficacy and safety of patient treatments.

This includes antibody constructs, gene and cell therapy products. These modalities have become an important part of the current biopharmaceutical pipeline reflecting a robust, diverse clinical research effort across many different therapeutic areas.

In bioprocess development and commercial manufacturing the diverse product pipeline encounters an existing process platform tailored to the needs of monoclonal antibodies, and production facilities which were designed more than 20 years ago. Moreover, increased speed-to-clinic and speed-to-market have become a standard requirement in bioprocess development.

Combined with increased health authority requirements and a strong industry trend towards cost reduction this is fueling innovation. For example, high-throughput experimentation, process modeling, lean process validation concepts and digital solutions for convenient access and evaluation of data are considered key technologies for smart process development.

This contribution aims to illustrate how bioprocess development can balance innovation in therapeutic modalities, speed, cost and patient safety.

HIC/DSP Bioseparation Conference