Chris Spivey is director of Industry Relations and Strategic Partnership, MJH Life Sciences.

Chris Spivey

Advances in Molecule Characterization and Biomanufacturing for Emerging Therapies was part of a keynote series at INTERPHEX 2021. This is Part 1 of 2.

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.

Pharmaceutical Technology, Pharmaceutical Technology Europe, and BioPharm International

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:

Equipment Trends in Advanced Solid-Dosage Drug Manufacturing

Serialization on a Global Scale: Deep Dive into the US DSCSA & EU FMD

Articles

Part 1—Industry experts from MilliporeSigma, Lonza, Astrea Bioseparations, and Sartorius discuss key issues affecting the development of emerging biotherapies.

Advances in Molecule Characterization and Biomanufacturing for Emerging Therapies: Part 1 

Conferences are back—the good, the bad, and the ugly. Each attendee experiences their own personal journey of unanticipated surprises, small misfortunes, physical and mental challenges, beneath the general background chaos. A constellation of unknown glittering prizes draws us back each year. In some ways, it feels like being part of an instinctual migratory movement. We are swept up in the excitement of the new, whilst transformed through reunification with the old.

It was my personal pleasure to be part of the 30-year celebration award dinner for the International Pharmaceutical Excipients Council (IPEC). Over friendly and informed conversation (I sat beside Stephen Hoag from the university of Maryland), we enjoyed a fabulous meal while hearing from five new scientists the salient points of their award-winning research. One of these, Rishi Thakar from the University of Texas at Austin, employed one of my favorite technologies—selective laser sintering—to improve formulation porosity when dealing with poorly soluble APIs. I had not previously appreciated in any real sense the potential benefits of 3D printed drugs.

At the AAPS, PharmSci 360 event in Philadelphia and INTERPHEX in New York City, we assembled in large numbers huddled around gleaming machines in capacious exhibit halls. We met at intimate restaurants with new sales prospects, or past colleagues. We sat in classroom-like auditoriums to hear scientific presentations redolent of our university youth. And we arranged site visits to local suppliers or customers.

A high point for me came when my normal office self, and my conference embodiment, both meet the author of an article that had earlier grabbed my attention while editing it. Nitin Swarnakar from BASF wrote an absorbing piece on Self Emulsifying Drug Delivery Systems. Within the article was a small section that had eluded my full comprehension, and I had made a physical note to return to the literature at some future point to clarify. Especially to better understand how this small aspect connected to the wider world of biology. Nitin was delighted to share what he knew at our booth, while to rest of the conference world swirled ceaselessly in the background. This happenstance genuinely made my day. Conferences are like that, they frustrate, and they exhaust, but serendipity and comradery draw us back. Year after year.

Can We Agree on Conferences?

Just in time (JIT) manufacturing aims to reduce flow times within manufacturing systems while cutting response times from suppliers and thence to customers. Under favorable circumstances, it’s a helpful tool for a manufacturer’s overarching strategy. With the emergence of additive manufacturing alongside rising software sophistication, JIT’s dominance of supply chain management appeared assured.

And then COVID-19 hit.

MJH Life Sciences sees CPhI’s global event in Milan, Italy as an ideal meeting place to rethink, recalibrate, and retool for the next decade of pharmaceutical manufacturing expansion. The ability to congregate face-to-face is a clear opportunity to build on that sense of community, which is so strong in the pharmaceutical industry. Among the many trends accelerated by the pandemic, the urgent requirement to build multiple additional supply partners into any future proofed supply and distribution chain has become clear. An anticipated vial shortage never became a critical bottleneck, partly because the raw materials themselves failed to arrive. Large companies had leveraged their outsized influence over suppliers—sometimes at the expense of customers, sometimes countries, and sometimes patients. This reinforces the necessity for face-to-face meetings, to rebuild trust, and to reduce hoarding and the threatening implicit bias of regionalism.

Rejoin the pharmaceutical community in Milan to engage with new partners, and to energize a supply chain infrastructure strategy with inherent adaptability and parallel inputs. Celebrate the obvious successes the industry had in meeting the COVID-19 challenge, and re-tool with a new understanding of how best to face common goals—together.

When referring to this article, please cite it as C. Spivey, “Rethinking, Recalibrating, and Retooling," 

CPhI is set to provide the pharma community with an ideal platform to engage with new value chain stakeholders post-COVID.

Rethinking, Recalibrating, and Retooling

I have the privilege to step into the shoes of an industry powerhouse. For a decade, Rita Peters kept a steady and assured gaze on the pharmaceutical industry. She informed, she educated, but above all Rita maintained a faithful register of its many successes and milestones. My career began by setting the science agenda for biotech conferences. People were friendly. The air was brimming with optimism and adventure. Genetics rapidly became genomics, and human health was poised for transformation. I enjoyed the distinction of co-founding the Human Proteome Organization alongside my friend and mentor Ian Humphrey-Smith.

While gains have taken time, one can draw a straight line from those turn-of-the-millennia days to a growing body of successful cell and protein therapies. In the background, the bulk of the heavy lifting was achieved through the hard work of small molecules. As I write, three (non-intravenous) antiviral pills undergo clinical trials for COVID-19. Molnupiravir comes from Merck & Co. and Ridgeback Biotherapeutics. Another comes from Pfizer, known as PF-07321332, and AT-527, from Roche and Atea Pharmaceuticals. I mention these because they represent a sea-change from how we typically treat emerging pathogens. We have evolved and adapted to this new threat. The pharmaceutical industry has come a very long way from medicinal plants shipped in barrels.

Media outlets such as Pharmaceutical Technology, Pharmaceutical Technology Europe, and BioPharm International are not mere impartial observers. We help align the warp and weft of the development and manufacturing agenda. As we emerge from the shadow of COVID-19, the air brims with optimism and adventure again. We look forward to sharing our stories and learning from our readers. Our chief objective is to continue the legacy of excellence that is now synonymous with these publications so that we may build carefully upon the community and network our editors have long been integral to. It is my honor to work alongside a strong publishing team including expert editors Jennifer Markarian, Feliza Mirasol, Meg Rivers, Felicity Thomas, Susan Haigney, Grant Playter and publisher Mike Tracey. The team roster has changed, but not the goal line.

Change of roster does not change the goal line. We are all patients first.