Biopharmaceutical Manufacturing: CASTL’s Support for Life Science Innovators and Entrepreneurs
Talk: “Translating your Drug Target from R&D Bench to First-in-Human Clinical Studies”
With industry partner and guest speaker BrevisReferro
CASTL Abstract: The accelerator landscape in Toronto and Mississauga provides early-stage life science founders with access to wet lab spaces and equipment, enabling them to develop their innovations towards commercialization. Understanding biomanufacturing and its processes will allow researchers and innovators to focus on product development while crafting a sound scale-up strategy for successful product launch/market entry.
In this webinar we will highlight:
Key areas of knowledge necessary for effectively engaging with outsourcing partners and advancing your innovation from the lab to the market
Industry requirements to enhance communication with outsourcing partners
How to develop a knowledgeable workforce to support and accelerate life sciences innovation towards manufacturing
Brevis Refero Abstract: Drug target discovery and validation can be a daunting activity for any researcher, once completed, technology transfer becomes the pivotal step in progressing a drug candidate towards clinical trials. Technology transfer involves the work of packaging and transferring key information from the R&D bench to a selected contract service provider, to progress the manufacturing of the drug candidate. This SpinUp@UTM webinar walks participates through an understanding of forecasting costs and timelines to enable first-in-human studies, through to how to effectively select a contract service provider, to key steps and information to ensure a successful technology transfer of the drug development program.
Background
The accelerator landscape in Toronto and Mississauga provides early-stage life science founders access to wet lab spaces and equipment enabling these startup ventures to develop their innovations towards commercialization. The demand for skilled talent is amplified by recent unprecedented investment in the R&D and life sciences industries by all levels of government in Canada. These investments are made to ensure that Canada has the facilities, technology, and workforce in place to support and accelerate life sciences innovation and manufacturing.
About CASTL
The Canadian Alliance for Skills and Training in Life Sciences (CASTL) provides industry-informed technical skills development and training in life-sciences, specializing in biopharmaceutical manufacturing. Partnered globally with NIBRT (National Institute for Bioprocessing Research and Training) in Ireland, and with the adMare Academy nationally, CASTL delivers on the future skills needs of the fast-growing bioscience sector. CASTL is well-positioned to provide training to accelerator-onboarded start-up companies with a focus on working knowledge of the biomanufacturing industry including information and strategies to help de-risk the tech transfer process starting early during product development. CASTL training programs provide a competitive edge for these companies as they work towards commercialization and manufacturing, and we are proud to support the next generation of highly qualified personnel to drive the growth of Canadian life sciences companies.
CASTL’s State-of-the-Art Training Solutions
CASTL offers multiple applied learning streams and pathways for individuals to acquire the hands-on technical training, theoretical knowledge, and professional skills needed to have a successful career in life sciences. We deliver this training via in-class or virtual classrooms for theory and practical hands-on training at one of our training facilities. CASTL curriculum can be customized to meet the needs of clients and covers all components of the biopharmaceutical manufacturing process including:
General overview of bioprocessing
Fermentation equipment
Upstream processing
Downstream processing
GxP including GLP, GDP, GMPQuality control bioanalytics
Cell culture platforms and technologies
Single Use technologies
Harvest methods
Formulation, fill finish and lyophilization
Quality control analyticsQuality control microbiology
Meet the Speakers
Magdalena brings over 14 years of experience across academia and industry, particularly in start-up companies. She obtained her Ph.D. Pharmacy from the University of Nottingham in stem cell tissue engineering, specializing in defined culture systems for pluripotent stem cells, followed by postdoctoral work at Nottingham developing cell culture automation technologies for biomaterials screening. Across various roles at CCRM, Source BioScience plc., Solarvest Inc., and Because, Animals Corp. (now BioCraft) she has demonstrated expertise in process development for cell manufacturing, as well as experience in quality management and developing IP. At Because, Animals, she set up an R&D laboratory, trained a team of scientists and technicians and led the bioprocess development of scalable stem cell culture to create cultured meat for pet food. In addition to her breadth of scientific know-how, she has completed the post-graduate certificate in Research Administration at Mohawk College and is a student of law at Queen’s University.
Sven has more than 15 years of experience in biopharmaceutical industry and R&D. He holds a PhD in Chemical Engineering from Polytechnique de Montréal and has led teams and projects within academic and industrial/GMP manufacturing environments. He is specialized in bioprocessing to produce viral vectors, vaccines, recombinant proteins and cell therapy products. His previous role (2019-2022) was with ExCellThera, a clinical stage cell therapy company, where he led the manufacturing and process development activities and contributed to developing a cell therapy product towards commercial approval.
Previously, he worked at the National Research Council Canada (2014-2019) where he built and managed a team focusing on scaling-up cell culture-based suspension processes. This included process development and technology transfer of upstream bioprocesses using multiple cell line platforms. One of the focus areas was the development of perfusion-based lentiviral vector production processes, which Sven started to work on in 2006 as a PhD student under Amine Kamen’s supervision. Together with collaborators and colleagues, he has published more than 20 peer-reviewed manuscripts. Since 2019, he is also an Adjunct Professor in the Department of Bioengineering at McGill University.
Umesh has more than 20 years of experience in biotechnology industry and R&D and holds a PhD in Biosystems Engineering from the University of Manitoba. He has worked in the BC biotech sector for over 10 years as Senior Director at Qu Biologics Inc., and as Director of Process Development at Symvivo Corporation. He led the CMC and PD teams to manufacture research product for pre-clinical trials, GLP-toxicological studies, and to further the Investigative Product (IP) in-house for Phase 1 clinical trials internationally. Umesh assisted CDMOs in their tech transfer and collaborated with external partners where he conducted external GMP site visits and trained on the topics of fermentation, up and downstream processes, purification of products, and commercialization of QC products.
He has contributed to implement a Quality Management System for CMC and Drug Production operations, ensuring adherence to SOPs, and overseeing QC operations and QA documentation. He has experience overseeing GMP Drug Product manufacturing for phase 2 clinical trials in Canada, along with managing Drug Product and Bulk Drug Substance stability programs and regulatory submissions to Health Canada.
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