Keynotes Lectures

HIC/DSP Bioseparation Conference


Roman Necina, Ph.D.
Roman is heading the Process Science and Technical Services team at Shire.
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.

HIC/DSP Bioseparation Conference