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

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 Senior Scientist at Boehringer Ingelheim Pharma GmbH & Co. KG in the Analytical Development Biologicals department, where he is employing his expertise as a virologist to establish analytical methods to characterize oncolytic viruses and viral vectors for gene therapy. He has 16 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.

Chapter 1: Bioprocessing and analytical development for virus-based therapeutics.- Chapter 2: Viral Vector Upstream Processing and Clarification.- Chapter 3: Upstream processing of viral therapeutics: From host cell expansion to virus production.- Chapter 4: Leveraging virus biology and host genetic conflicts for cell line development and engineering for virus-based therapeutics.- Chapter 5: Overview of Current Downstream Processing for Modern Viral Vectors.- Chapter 6: Filtration Principles and Techniques for Bioprocessing of Viral Vector-Based Therapeutics.- Chapter 7: Chromatographic purification of viruses: State of the art and current trends.- Chapter 8: Purifying Viral Vectors - A Review of Chromatography Solutions.- Chapter 9: Particle analytics - Comparative approaches for analysis of viral vectors.- Chapter 10: Phase-Appropriate Potency Assay Development for AAV-based Gene Therapy Products.- Chapter 11: Quantification of virus infectivity - the key assay for the development ofviral therapeutics.- Chapter 12: Product-related impurities in therapeutic virus bioprocessing.- Chapter 13: Process Analytical Technologies (PAT) and Quality by Design (QbD) for bioprocessing of virus-based therapeutics.- Chapter 14: Methods and practical considerations in imaging viral therapeutics.- Chapter 15: Application of NMR Spectroscopy in Viral Assembly Characterization.- Chapter 16: Improved Production Strategies for Oncolytic Measles Viruses as a Therapeutic Cancer Treatment.- Chapter 17: Recent Advancements and Challenges in Recombinant Expression for Commercial Production of Virus Like Particles (VLPs).- Chapter 18: Oncolytic viruses and viral gene therapy vectors: Principles of safety.