Advances in Molecule Characterization and Biomanufacturing for Emerging Therapies: Part 2

Advances in Molecule Characterization and Biomanufacturing for Emerging Therapies was part of a keynote series at INTERPHEX 2021. This is Part 2 of 2.

Watch Part 1 posted on Nov. 8, 2021.

About the keynote

The progression of increasingly complex biological molecules in early drug development poses unique challenges to their analytical characterization, which, in turn, impacts the design and approach of biomanufacturers to the bioprocesses needed to produce these molecules, both in the lab and at scale up/scale out. This session will explore current advances in analytical methodologies and equipment starting at the benchtop and carrying through to process analytics and process development.

Moderated by:

Chris Spivey, Editorial Director, Pharmaceutical Technology, Pharmaceutical Technology Europe, and BioPharm International

Feliza Mirasol, Science Editor, Pharmaceutical Technology, Pharmaceutical Technology Europe, and BioPharm International

About the speakers

Gregory Berger, Product Manager, Virus-based Therapeutics—Gene Therapy, Sartorius

Greg is part of the Viral Based Therapeutic product management team at Sartorius bringing a wealth expertise in viral vector/cell line development, vector production in bioreactors and development of appropriate analytical tools for characterization and functionality assessment. Greg obtained his PhD in Virology and Immunology from the Ecole Normale Superieure de Lyon (ENS Lyon) in France, focusing upon the development of new Lentiviral vectors for the development of Dendritic cell-based immunotherapy. He then joined the department of Immunobiology and Infectious Disease at King’s College London as a post-doctoral researcher where his work focused predominantly on viral vector integration and immune cell dysfunction upon transduction. Prior Joining Sartorius, Greg worked at the Cell and Gene Therapy Catapult where he led the development of an End-to-End AAV manufacturing platform to address the current challenges regarding viral vector manufacturing.

Ahmed Besheer, Head Formulation Development, Lonza Drug Product Services

Ahmed Besheer has extensive experience in drug product development, with ten years of industry experience. Before joining Lonza in 2018, Ahmed worked at Novartis and Merck Serono in parenteral formulation development as DP project lead and later as head of NBE formulation development. At Lonza, Ahmed leads a team that develops drug products of monoclonal antibodies, recombinant protein, fusion proteins, bioconjugates, antibody fragments, nanobodies, and viral vectors. He has extensive experience in the formulation of liquid and lyophilized early- and late-phase Drug Product for various administration routes.

Ahmed earned his pharmacy degree from Ain Shams University, Cairo (EG), holds a PhD in pharmaceutical technology from the University of Halle (DE), and worked as an assistant professor at the University of Munich (DE)

Lowell Brady, Head Drug Product Phys-Chem Analytical Development, Lonza Drug Product Services

Lowell Brady leads the Phys-Chem analytical development team at Lonza Drug Product Services, which is responsible for analytical method development and support of specification setting and the analytical control strategy for customer products. Prior to joining Lonza, Lowell worked in analytical and CMC roles at large biotech and pharmaceutical companies. Lowell has a broad range of expertise ranging from in-depth characterization of protein therapeutics using mass spectrometry to the development of routine quality control methods for product release and stability testing. Lowell has experience defining strategies for supporting all stages of product and process development, from early pool/clone screening through BLA filings.

Sébastien Ribault, PhD, Vice-President and Head of End-to-End Solutions, part of the BioReliance® portfolio, MilliporeSigma

Sébastien joined MilliporeSigma in 2005 and is vice-president and head of End-to-End Solutions and the managing director of the Biodevelopment Center located in Martillac, France, where he leads the CDMO branch dedicated to large molecules within MilliporeSigma. Sébastien also supports the development of new and innovative biomanufacturing technologies and solutions in collaboration with the company’s process development team.

Prior to joining MilliporeSigma, he was a gene therapy development scientist at Transgene and was head of the R&D laboratory and member of the board of directors at Hemosystem, an in-vitro diagnostics company. Sébastien received his microbiology engineer degree from the Engineer School of Luminy, Marseille, France and his PhD in molecular and cellular biology from the University of Strasbourg.

Marc Hummersone, Senior Director, Research & Development, Astrea Bioseparations

Marc Hummersone has over 20 years of project and managerial experience in both big and small technology companies, including industry leaders AstraZeneca, General Electric Healthcare, and Cytiva. He has a broad experience base across a wide range of technologies including the development of novel chromatographic media for the purification of complex biological feed streams as well as drug discovery and development. He was a key contributor to the development of the Fibro chromatography family of products which resulted in the acquisition of Puridify, by GE Healthcare in 2017. Additionally, he was a key part of the management team who validated the concept of synthetic lethality and who identified and developed Lymparza, which is an approved drug for the treatment of BRCA-mutated advanced ovarian cancer which resulted in the acquisition of KuDOS Pharmaceuticals in 2005, by AstraZeneca. Marc has held positions including Company Director, Chief Scientific Officer and Department Director. He gained a PhD and Post-Doctoral experience in chemistry which was focused on the total synthesis of complex natural products at University College, London.

Watch other videos in this keynote series:

1. Equipment Trends in Advanced Solid-Dosage Drug Manufacturing
2. Serialization on a Global Scale: Deep Dive into the US DSCSA & EU FMD
3. The Evolution of Aseptic Processing