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mRNA Process Development, Quality & Manufacturing Summit

  • 26th – 27th March 2024
  • Austria flag Austria Vienna & Online

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 2024 contains additional info and the key insights of the mRNA process development and manufacturing.

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About the mRNA Process Development, Quality & Manufacturing Summit (#VLmRNA)

The 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:

  • Proper characterisation of mRNA during development and quality control (QC)
  • Standardisation and cost-effective techniques for manufacturing
  • Dedicated equipment and expertise for expanding mRNA processes on a large and a small scale

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 2024 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.

Who should attend

  • Analytics
  • Analytical Science
  • Bioprocessing
  • Cancer Immunotherapy
  • Clinical Development
  • Chemistry, Manufacturing, and Control (CMC)
  • Commercialisation
  • Comparability
  • Good Manufacturing Practices (GMP)
  • Drug Product Development
  • Drug Substance
  • Impurities
  • Innovation Chemistry
  • In-Vitro Transcription
  • Formulation
  • Lipid Nanoparticles (LNP)
  • Manufacturing, Science & Technologies (MSAT)
  • Messenger RNA (mRNA)
  • mRNA-Based Therapies
  • Oncology
  • Plasmid DNA (pDNA)
  • Process Analytical Technology (PAT)
  • Product Characterisation
  • Process Development
  • Production Engineering
  • Purification
  • Ribonucleic Acid (RNA)
  • RNA Therapeutics
  • Quality Assurance (QA)
  • Quality by Design (QbD)
  • Quality Control (QC)
  • Research and Development (R&D)
  • Regulatory
  • Safety
  • Scale Up
  • Supply Chain
  • Vaccines

Register by End of February for Early Bird

+20% discount on all sponsorship packages

The Early Bird Offer expires in 5 days!

REQUEST A BROCHURE

To request an agenda for this Summit, please complete the details below. We will send you the agenda via email.

Key Practical Learning Points

  • Meeting technical and regulatory hurdles developing and manufacturing mRNA vaccines
  • Overcoming complexity, difficulties, and misdirection of mRNA process development and manufacturing
  • Advancing CMC roadmap for the production of mRNA therapeutics
  • Ensuring consistent quality, long-term safety and efficacy of mRNA vaccines
  • Achieving optimised, intensified, and continuous mRNA production
  • Building better analytical strategies for rapid mRNA production
  • Supporting requirements for characterisation of structure, purity, and efficacy of an mRNA drug substance
  • Exploring regulatory considerations for the development of mRNA-based vaccines
  • Implementing the latest science, tech, automation, and digitalisation to accelerate mRNA manufacturing
  • Effectively scaling up manufacturing methods to enable mass production of mRNA vaccines

Register by End of February for Early Bird

+20% discount on all sponsorship packages

The Early Bird Offer expires in 5 days!

Dr. Roland Pach, CH

Global Expert Cell and Gene Therapy Analytics

Roche

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).

Dipendra Gyawali, US

Sr. Scientist, Team Lead, Process Development Characterisation

Moderna

Dipendra Gyawali works as a senior scientist in the LNP process development department at Moderna, based in Cambridge, Massachusetts. He obtained his master of science degree in 2009 from UT-Southwestern Medical Center/UT-Arlington, specialising in bioengineering with a focus on biomaterial and drug delivery. He has co-authored 25 peer-reviewed scientific journal papers, contributed to three book chapters, and invited interviews with over 1,500 citations to his work. Additionally, he holds four US and international patents. Dipendra’s primary research involves understanding the significance of biomaterials in mRNA delivery and overseeing detailed characterisation of lipid nanoparticles employed in mediating mRNA delivery.

Anna Särnefält, SE

Director CMC

Coalition for Epidemic Preparedness Innovations (CEPI)

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.

Laurens Vergauwen, BE

Process Development Scientist

Merck Group

Dr. Roman Matthessen, BE

Process Development Manager

Pfizer

Holding a PhD in bio-engineering catalytic technology from KU Leuven, Roman’s journey at Pfizer spans over eight years, reflecting a versatile career path, ranging from engineering to production. For the past two years, he has stood at the forefront of innovation as process development manager in the experimental pilot plant in Puurs, as part of the mRNA technology group. As a certified six sigma green belt, Roman is a driving force behind critical investigations, contributing to the advancement of the LNP formulation process.

Dr. Xinyue (Frank) Zhang, US

Manager - mRNA Process and Analytical Development

GeneLeap Biotechnology

Dr. Xinyue (Frank) Zhang earned his PhD from the Chinese Academy of Sciences – Institute of Chemistry. He's had the privilege of working at institutions such as the University of Missouri-Columbia and UST. For over 10 years, Xinyue has dedicated his research to nucleic acid-related areas, delving into aptamers, biosensors, nanopores, and mRNA process development. His findings have been published in reputable journals, including Nature Communications, JACS, and ACS Nano. In 2021, Xinyue joined GeneLeap Biotechnology, where he focusses on mRNA process and analytical development, along with manufacturing.

Dr. Camille Correia, DE

Head of Reaction Technology

Merck KGaA

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.

Dr. Dennis Christensen, DK

Head of Global R&D, Adjuvant Systems

Croda Pharma

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. Siddharth Bhoraskar, US

Scientist II, Analytical Research & Development

Beam Therapeutics

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).

Dr. Mark Dickman, UK

Professor of Bioanalytical Science and Engineering, Dept of Chemical and Biological Engineering

The University of Sheffield

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. Steven Wolk, US

Vice President of Chemistry & Boulder Site Head

Editas Medicine

Steve Wolk is currently the vice president of chemistry and boulder site head for Editas Medicine, where he leads the process chemistry and analytical sciences and structural biology teams. His scientific teams are responsible for gRNA and mRNA manufacture and characterisation, conjugation chemistries, as well as analytical method development, QC, and stability testing, and biophysical and structure/function characterisation. He received his bachelor’s degree in chemistry from UC San Diego, where he received the Harold Urey Award. He completed his PhD work in biophysical chemistry under Dr. Ignacio Tinoco at UC Berkeley, where he used 2D-NMR and other spectroscopic techniques to characterise nonstandard DNA structures. He has also led analytical groups at a polymer company (Rohm and Haas) as well as numerous other biotechnology companies (NexStar, Invenux, Amgen, and SomaLogic), and has a broad background in analytical techniques used for the characterisation of both small and large molecules.

Dr. Francis Poulin, US

Vice President, Analytical Sciences

Sail Biomedicines, Inc.

Dr. Ilaria Pettinati, NL

Group Lead Process Development mRNA

Lonza

Ilaria Pettinati is group lead process development mRNA at Lonza Geleen. Before joining Lonza, she worked at eTheRNA Immunotherapies NV where she led the mRNA chemistry team. Previously she was at Oxford Biomedica focussing on process development in the field of lentiviral vectors and other biomolecules, including nucleic acids. Ilaria has a master’s in cellular and molecular biology and a PhD in biophysics in the field of drug discovery, obtained in collaboration with the University of Oxford, where she elucidated structural and mechanistic basis of RNA processing enzymes.

Dr. Suzanne R. Saffie-Siebert, UK

Founder & CEO

SiSaf Ltd

Dr. Julen Oyarzabal, ES

Co-Founder & CSO

Syngoi

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. John (Junyi) Li, US

Director, mRNA Drug Substance

Capstan Therapeutics

John J. Li is the director of RNA drug substance at Capstan Therapeutics where he focusses on process development, technology innovation, and CMC for RNA therapeutics. John has broad technical experience in platform process design with respect to various drug modalities such as monoclonal antibody, antibody variants, ADC, AAV/Lentivirus, Plasmid DNA, and recombinant proteins. He holds a PhD in structural biology from the University of Toronto, Canada, where he studied protein kinase catalytic mechanisms by x-ray crystallography.

Dr. Roland Pach, CH

Global Expert Cell and Gene Therapy Analytics

Roche

Dipendra Gyawali, US

Sr. Scientist, Team Lead, Process Development Characterisation

Moderna

Anna Särnefält, SE

Director CMC

Coalition for Epidemic Preparedness Innovations (CEPI)

Laurens Vergauwen, BE

Process Development Scientist

Merck Group

Dr. Roman Matthessen, BE

Process Development Manager

Pfizer

Dr. Xinyue (Frank) Zhang, US

Manager - mRNA Process and Analytical Development

GeneLeap Biotechnology

Dr. Camille Correia, DE

Head of Reaction Technology

Merck KGaA

Dr. Dennis Christensen, DK

Head of Global R&D, Adjuvant Systems

Croda Pharma

Dr. Siddharth Bhoraskar, US

Scientist II, Analytical Research & Development

Beam Therapeutics

Dr. Mark Dickman, UK

Professor of Bioanalytical Science and Engineering, Dept of Chemical and Biological Engineering

The University of Sheffield

Dr. Steven Wolk, US

Vice President of Chemistry & Boulder Site Head

Editas Medicine

Dr. Francis Poulin, US

Vice President, Analytical Sciences

Sail Biomedicines, Inc.

Dr. Ilaria Pettinati, NL

Group Lead Process Development mRNA

Lonza

Dr. Suzanne R. Saffie-Siebert, UK

Founder & CEO

SiSaf Ltd

Dr. Julen Oyarzabal, ES

Co-Founder & CSO

Syngoi

Dr. John (Junyi) Li, US

Director, mRNA Drug Substance

Capstan Therapeutics

BROCHURE

Request the mRNA Process Development, Quality & Manufacturing Summit brochure and find out the latest topics and ideas that will be shared.

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What our
participants
are saying

The #VLmRNA summit provides a comprehensive overview of the latest advancements in mRNA technology. I am particularly interested in the potential scalability and rapid manufacturing adaptation for different protein targets. The networking opportunities are valuable to foster collaborations for future projects.

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The discussions at the summit will shed light on the importance of standardization in mRNA manufacturing. I appreciat the emphasis on collaboration between industry and regulatory authorities to streamline CMC development. This will be crucial in bringing innovative mRNA products to the market efficiently and safely.

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Attendee

The highlight of the summit is the emphasis on effective techniques for mRNA manufacturing.

The challenges and solutions discussed during the event will be highly relevant to my company's ongoing mRNA projects. I will be more confident in navigating the complexities of mRNA process development and scaling up our production.

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