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The development and manufacturing of mRNA therapeutics and vaccines present a remarkable advantage in terms of simplicity, scalability, and speed.
The mRNA Process Development, Quality & Manufacturing Summit in Vienna is dedicated to accelerating the end-to-end mRNA process development and manufacturing, enabling successful scale-up of mRNA therapeutics and vaccines, utilising new technologies and ensuring product quality, formulation, delivery, and managing complex supply chains.
Throughout the #VLmRNA summit, we will delve into key areas for process optimisation, cost efficiency, and managing tactical complexities across various steps of mRNA process development.
The #VLmRNA brochure 2023 contains additional info and the key insights of the mRNA process development and manufacturing.
Read moreThe transformative potential of mRNA lies in its unique attributes, related to safety, rapidness, and efficacy. Relatively simpler and adaptive mRNA manufacturing processes enable GMP facilities to switch to a broader range of druggable targets with minimal adjustment to process and formulation. Nevertheless, the journey of process development and manufacturing optimisation for mRNA is still in its early stages.
The mRNA Process Development, Quality & Manufacturing Summit in Vienna is dedicated to accelerating the end-to-end mRNA process development and manufacturing, enabling successful scale-up of mRNA therapeutics and vaccines, utilising new technologies and ensuring product quality, formulation, delivery, and managing complex supply chains.
Throughout the #VLmRNA summit, we will delve into key areas for process optimisation, cost efficiency, and managing tactical complexities across various steps of mRNA process development, including plasmid production, in vitro transcription (IVT), purification, lipid nanoparticle (LNP) encapsulation, and storage.
While the future of mRNA therapeutics is promising, there are challenges that need to be addressed, including, but not limited to the lack of:
Looking ahead, mRNA technology is aimed to play a pivotal role in advancing the development of vaccines for infectious diseases, addressing the therapeutic landscape for non-viral gene and cell therapies, as well as holding the potential to offer solutions for personalised medicine and rare diseases.
The transformative power of the mRNA production lies in the convergence of science, technology, regulatory standards, tailor-made equipment, and innovative facility design.
Join the key experts at the #VLmRNA 2023 to explore how the mRNA-based therapeutics and vaccines to be produced with the better efficiency and at a reduced cost, leveraging future perspectives of mRNA development and manufacturing.
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About Speaker
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Dr. Roland Pach holds a PhD in molecular parasitology at the University Fribourg analyzing the intracellular trafficking of transgenic RNA in human pathogens.
Prior Roche, he was leading the Analytical Development department at Berna Biotech (former Swiss Vaccine and Serum Institute) and the QC department of Bio-Process Development at Merck Serono.
Roland is the global CMC Analytical Technical Lead in the cancer vaccines and cell- & gene therapy (CGT) area of Roche more than 10 years. In his assigned area, he represents Roche in external development projects, industrial consortiums like CGT BioPhorum and numerous due diligences of in-licensing candidates or companies in the CGT fields.
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).
Siddharth Bhoraskar is currently working as a scientist at Beam Therapeutics with the analytical research and development team based in Cambridge, MA. He has been involved in early-stage LC/LC-MS characterisation of lipids, mRNA, sgRNA, and lipid nanoparticles. Over the period of three years at Beam, he has held roles with increasing responsibly and currently is the analytical mRNA lead for Beam’s pipeline programs, spearheading the tech transfer and qualification/validation activities internally and with external partners thereby supporting research as well as CMC teams in driving Beam’s molecules from pre-clinical to clinical stage. He received his PhD in chemistry from the University of Massachusetts Lowell (USA), a master’s in pharmaceutical sciences from Northeastern University (USA) and a bachelor’s in pharmacy from Devi Ahilya University (Indore, India).
Anna Särnefält joined the Coalition for Epidemic Preparedness Innovations (CEPI) as CMC lead at the beginning of 2020. She previously worked as a team leader and senior scientist within process development of viral vectored vaccines at Bavarian Nordic A/S and has experience within antibody drug discovery from BioInvent AB following her MSc degree in chemical engineering (biotechnology) from the faculty of engineering at Lund University, Sweden.
Khaled Yamout is the senior director of analytical services and quality control at TriLink Biotechnologies, where he oversees all analytical aspects of method development and validation to product release and stability to support regulatory filings for both small and large molecules. Prior to TriLink, Khaled held various positions in QC, R&D, and manufacturing, where he supported a number of drug substances and drug products (both small molecules and biologics) from clinical phase to commercial. These include diverse experience and expertise ranging from discovery to manufacturing with Fortune 500 firms, as well as small entrepreneurial businesses in the areas of synthetic, analytical, colloidal, surface modification, protein, and antibody modification and purification covering both manufacturing and analytical testing and characterisation.
Padmadhar (Pad) Madupu has been working in the biotech industry for 20-plus years now. He currently works as head of manufacturing at Omega Therapeutics, a clinical company in Boston, MA (USA). Throughout his career, he has held several positions in manufacturing, science and technology, engineering, and technical leadership at various companies, including Bristol Myers Squibb, Genzyme, Amgen, and most recently at Pfizer.
His position at Pfizer was to lead the transfer group at the facility. In this position, he (along with his team) was responsible for transferring clinical and commercial molecules into manufacturing suites. He and his team were instrumental in transferring the Pfizer COVID vaccine to manufacturing in a very short time.
He has a passion for developing a collaborative work culture in organisations. He also considers technical problem solving as his one of his strengths. Pad has a master’s degree in chemical engineering and several advanced learning certificates from various institutes.
Pad lives with his wife and two kids in the town of Tewksbury, MA (USA). In his spare time, he likes to play cricket and experiment with cooking food.
Dr. Camille Correia obtained her PhD at McGill University under the supervision of professor Chao-Jun Li, followed by a post-doctoral fellowship at the Max Planck Institute of Colloids and Interfaces with professor Peter H. Seeberger. Camille joined Merck in 2015 and is currently the head of reaction technology, with a focus on the development of continuous manufacturing processes.
For the last 19 years, Dr. Dennis Christensen has been working with pharmaceutical and immunological aspects of vaccine adjuvants and delivery systems, including targeted delivery of protein, peptide, and mRNA-based vaccines. He is a key opinion leader in the vaccine delivery research field and has an extensive experience with international vaccine research collaborations and with coordinating the research work in such projects. Dennis is leading Croda Pharma’s R&D efforts to offer of new and innovative vaccine delivery systems, immunostimulators, and combined adjuvant systems for the future.
Dr. Julen Oyarzabal has spent more than 20 years working in the drug discovery and biopharmaceutical industry. Julen started his career as a researcher at the University of California San Francisco (UCSF) and later he joined the University of Southampton (UK), where he got extensive experience in pharmaceutical chemistry and drug design. In 2001, Julen joined Johnson & Johnson Pharmaceutical’s R&D team, where he led several projects from a molecular design perspective in the CNS therapeutic area. Five years later, he set up and led the computational medicinal chemistry section at the Spanish National Cancer Research Center (CNIO). In 2010, Julen joined the Center for Applied Medical Research (CIMA) at the University of Navarra (Spain) to set up the small molecule discovery platform and led the molecular therapeutics program. From 2013-18 he was also director of translational sciences leading scouting activities, from the University Hospital and CIMA, as well as de-risking drug discovery processes; as a result, several collaborations have been established, as well as a license agreement, with big pharmaceutical companies.
Julen is co-inventor of more than 30 patents and has published more than 100 peer-reviewed scientific articles. He (co-)led publications in prestigious journals such as Nature Comm, Angew Chem, or J Med Chem. In addition, he was on the board of directors for the Academic Drug Discovery Consortium (USA) for six years (as VP from 2020-22); and, for seven years, from 2012, he was member of the European Medicines Agency (EMA) experts’ panel. He is on the board of directors of four biotechnological companies and he is co-founder and CSO of Syngoi.
Julen received a bachelor’s in physical chemistry and a PhD in organic and pharmaceutical chemistry, extraordinary prize, from the University of the Basque Country (Spain).
Dr. Mark Dickman obtained his PhD at the Krebs Institute at the University of Sheffield prior to joining a biotechnology company, Transgenomic LTD, where he developed analytical techniques, including DNA/RNA chromatography. Mark joined the department of chemical and biological engineering in 2003. He has over 25 years' experience in the development and application of analytical techniques to analyse nucleic acids. In particular, he focusses on the development of novel biological mass spectrometry and HPLC methods to characterise mRNA therapeutics/vaccines.
Dr. Andreas Wagner is head of liposome technology at Polymun Scientific GmbH. He has significant expertise formulation of liposomes and LNPs and development of the respective processes for their clinical use. He and the team at Polymun Scientific have significantly contributed to the first successful mRNA vaccine Comirnaty by optimising and up-scaling the LNP process as well as by supporting clinical and early market supply of the successful COVID-19 vaccine.
Andreas studied biotechnology at the University of Applied Life Sciences in Vienna, Austria, and earned his master’s and PhD degrees in the field of biopharmaceutical technology. He’s listed as inventor on multiple patents, like the liposome technology and some product patents of liposomal formulations. Furthermore, he has published several peer-reviewed articles dealing with liposomes, the technology, products thereof, and their application in preclinical and clinical studies.
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