This month, BioCentriq hosted a webinar in collaboration with Phacilitate called Setting the Stage for Successful Manufacturing of Cell and Gene Therapies Webinar. It consisted of a panel of industry leaders giving much-needed lessons on how to ensure quality, improve patient access, and reduce the cost of manufacturing. But don’t worry if you missed it. Here’s a recap of who participated, everything we discussed, and how you can access it on demand.
Who Participated
We brought together a panel of industry experts to shed light on where most early stage biotechs go wrong in overestimating their readiness. Throughout the webinar, they encouraged taking an in-depth look at your products, capabilities, technologies, processes, and teams, preparing viewers for success as they bring their product from the bench to patients worldwide. Take a look at the experts we featured.
Alex Klarer, Director of MSAT, Head of Research & Development at BioCentriq
Alex Klarer has a background in Chemical Engineering focused on bioprocessing and process engineering. Over the last 7 years, he has held roles at Genentech and Hitachi, where he led the translational process development for a range of cell therapies and ex-vivo gene therapies including T-cell, DC and NK cell immunotherapies, stem cell therapies, and MSC mediated immunoregulation. Alex also has experience developing novel technologies and applications to address gaps in manufacturing capabilities.
Manish Jain, Senior Vice President of Technical Operations, Avenge Bio
Manish Jain has more than twenty years of experience ranging from small biotech to well established global biopharma demonstrating leadership in CMC development, technical operations, and supply chain of early phase to commercial biopharmaceuticals.
Most recently, Manish was the Vice President of Pharmaceutical Sciences and Manufacturing at Genocea, where he led Process Development, Analytical Development, External Manufacturing, and Supply Chain functions for the portfolio of neoantigen based personalized T-cell therapy and cancer vaccine. Prior to Genocea, Manish worked at several small and big biotechs including Momenta Pharmaceuticals, ImmunoGen, Amgen, and Human Genome Sciences in a variety of technical leadership roles developing multiple clinical and commercial drug products. Manish has expertise in early phase as well as late phase process and analytical development, technology transfer, scale up and scale out, manufacturing operations, and supply chain of biopharmaceuticals.
Manish holds a B. Tech. in Chemical Engineering from the Indian Institute of Technology, Bombay and an M.S. in Chemical Engineering from the University of Virginia.
Phil Vanek, Chief Technology Officer, Gamma Biosceinces
Phil is responsible for technical due diligence and evaluation of potential investments, as well as guiding operational, R&D and strategic initiatives carried out at portfolio companies. An entrepreneurial and strategic international business leader, Phil joins Gamma from GE Healthcare’s Cell and Gene Therapy business unit where he directed strategy and portfolio growth. Phil received his Ph.D. in Biochemistry and Molecular Biology at Georgetown University Medical Center followed by an IRTA fellowship at the National Cancer Institute in Maryland, and at the Hollings Cancer Center in Charleston, SC. Phil was an instructor for Johns Hopkins University Advanced Academic Programs teaching Biotechnology Marketing in the Masters of Biotechnology / MBA program, and has held leadership positions in a number of life sciences companies including Life Technologies, Becton Dickinson, and Lonza. Phil is a Board Member of CCRM in Toronto Canada and a Board Member of the ARM Foundation.
What We Discussed
These three experts told us how to avoid the common pitfalls therapy developers make when manufacturing cell and gene therapies. In the race to get novel therapies into clinical trials, early-stage biotechs must objectively assess their readiness and make critical decisions about where and how to manufacture. They provided the coveted insight needed to advance your readiness by sharing what key indicators to look for and how to assess them.
The topics we covered include:
- A well-defined product: why it’s so important to define specifications, dosing, QBD, CPP, and more early on
Manish elaborated on the work that needs to get done before you move into clinical manufacturing, specifically in terms of defining your product profile and corresponding specifications. He also discussed where the most tempting shortcuts are in establishing your product profile and the impact of taking those shortcuts. Alex gave insight on how often he sees sponsors trying to transfer a product for manufacturing that lacks a target QTPP or the corresponding process parameters, and the impact that has on the CDMO’s work in GMP readiness and manufacturing.
- Assessing scalability, repeatability, and GMP readiness of your manufacturing process
Alex discussed the checklist he uses when assessing the readiness of prospective clients, and what indicates he can successfully repeat what a client has done in a GMP environment with a clinical manufacturing team. Because Manish is now part of manufacturing for a Phase I clinical trial, he shared what made him feel confident that his process was ready to be executed in the clean room by manufacturing operators and not scientists. Finally, Phil pulled from his vast experience to share what he believes are the key indicators of readiness.
- Minimizing the chance of error, reducing contamination risk, and speeding up processing time
Phil spoke about how he typically works with early-stage biotech companies as a provider of emerging and advanced technologies to help them decide whether the investment in process improvements is worthwhile. Manish used his insight to share his decision-making process in terms of investing in additional process improvements, and Alex discussed what early-stage biotechs should look for when evaluating whether they must invest in additional process work.
- The criticality of having the right team built prior to manufacturing
Manish discussed how he believes having the right team is the single most important factor in clinical manufacturing, and Alex posed the thought-provoking question: what challenges or disruptions have you seen in the process when key players from the team Manish describes are not in place? He discussed how you can use that question to lobby internally for funding much-needed roles. Phil used his expertise to talk about how he’s seen technology and equipment providers help in this arena.
- Is outsourcing to a CDMO the right move, and are you ready for that partnership?
Manish highlighted the decision-making process that Avenge Bio used when deciding whether to build their own manufacturing capabilities or find a partner. Alex commented on the role he thinks CDMOs play in the industry as a whole and the benefits of working with a CDMO even if you have the funding and experience to build your own manufacturing capabilities. Finally, Phil revealed what he’s seen in terms of both successful and failed CDMO relationships and what he thinks the key success criteria are for those partnerships
How You Can Watch the Webinar Right Now
Immediately applicable, these tales from the trenches are guaranteed to save time and money by revealing what you don’t know until you’ve been through every step of clinical manufacturing.
What are you waiting for? You can watch it right now on demand. Click here to begin watching.