Bioprocess and Analytics Development for Virus-based Advanced Therapeutics and Medicinal Products (ATMPs)

This book reviews the knowledge, methods and available techniques in the rapidly advancing field of virus based vaccines and gene therapeutics. It also highlights new innovative tools and interdisciplinary techniques for bioprocess development and analytics of viruses and viral vectors. As such, it provides a timely and highly relevant resource, since current advances in pharmaceutical research have seen the rise of vaccines and advanced therapeutics and medicinal products (ATMPs), that rely on the power of viruses. However, developing bioprocesses and analytics required to create this often called “magic bullet” (i.e. gene therapy) remains an extremely challenging and costly task. This book offers strategies for overcoming hurdles and difficulties within in all the necessary steps of viral vector development - from scalability to purification methods and quality control.

The book is intended for researchers working in academia or industry, as well as graduate students pursuing a career in virology.

Dr. Saurabh Gautam is a Lab Head/Principal Scientist at ViraTherapeutics GmbH and Boehringer Ingelheim International GmbH based in Innsbruck, Austria. He is leading a group for bioprocess development and manufacturing of oncolytic viruses, viral vectors, and vaccines. So far, he has helped and contributed in bringing 3 advanced therapeutics and medicinal products (ATMPs) to clinics.

Previously, Dr. Gautam has also worked at the Max Planck Institute of Biochemistry, Martinsried, Germany within the group of Director Prof. Dr. Ulrich Hartl after obtaining his PhD from Indian Institute of Technology Delhi, India in 2016. He is also a recipient of highly prestigious Marie Curie individual fellowship from European Commission for his work at Max Planck Institute. More personally, he is interested in playing soccer, hiking, and cooking.

Dr. Abhilash I. Chiramel is a Principal Scientist at Boehringer Ingelheim Pharma GmbH & Co. KG and Head Of Therapeutic Virus Development Laboratory 2 (TVD2) within the Virus Therapeutics Center, Development Biologicals department. He is employing his expertise as a virologist to establish analytical methods to characterize oncolytic viruses and viral vectors for gene therapy. He has 17 years of experience researching the biology of viruses. His research interests fall in the axis of cell biology and innate immunity to viral infections. His work has been published in multiple journals in the field of virology - from elucidating ultrastructural details of RNA virus replication to characterizing innate immune responses to pathogenic RNA virus infections.

Dr. Roland Pach is the global CMC Analytical Lead in the cancer vaccines and cell- & gene therapy (CGT) area of Roche more than 13 years. In his assigned area of ATMPs, he represents Roche in external development projects, industrial consortiums like CGT BioPhorum, USP, CMO/CDMOs (audits) and numerous due diligences of in-licensing candidates or companies in the CGT fields. Together with his collaboration partners, he drove the definition & implementation of the control-, analytical development-, analytical comparability- and submission strategies and its cognate technologies.
In his second role at Roche as global technical development leader, he had led successfully new formats like immunotoxins from pre-clinics into entry to human (EiH).
Briefly, Dr. Roland Pach studied Life Sciences at the Biozentrum of the University Basel and holds a PhD in molecular parasitology at the University Fribourg analysing the expression of and mitochondrial trafficking of transgenic RNA in protozoan pathogens.

He started his industrial career in the role of the production head of DiTe vaccines at Berna Biotech (former Swiss Vaccine and Serum Institute). Subsequently he was leading the Analytical Development - and Process Analytics department covering diverse platforms like bacterial conjugate-, virosomal- and attenuated viral vaccines.

Prior Roche, Roland led the QC department of Bio-Process Development Drug Substance at Merck-Serono and advanced the implementation of QbD and Design Space at his labs applied to Interleukin- and Fc-fusion based drug molecules.