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How to accelerate the commercialization of your mRNA therapies

6 July 2023
Advanced Therapy Medicinal Products
Christine Boswell
Global Change Facilitator

Advanced therapies based on genes, tissues, or cells offer groundbreaking new opportunities to treat incurable diseases. Within these therapies, mRNA offers some unique advantages over other modalities, such as viral vectors. Its manufacture is a cell-free process that reduces the production timeline and makes it relatively simple to produce.

This has increased the demand for mRNA production while adding emphasis on streamlining the manufacturing process of new products. However, although product manufacture and process validation of biotherapeutics are routinely performed in industry, the process for mRNA manufacture is less well established and there are many differences between the manufacturing processes of companies.

BioPhorum’s new paper – Overview of end-to-end mRNA drug substance and drug product manufacturing processes and scale-up considerations – provides some much-needed clarity in this area.

It offers a starting point for developers who want to create their own process flow. It can also be used by anyone who wants to understand more about the manufacturing of mRNA and what each step entails, the capabilities, parameters, and equipment used.

“The flexibility of the mRNA platform enables accelerated development timelines to quickly address various diseases,” said Tatenda Shopera, Principal Scientist – Bioprocess R&D Upstream Process Development at Pfizer. “It’s great to see biopharmaceutical industry leaders coming together to provide great fundamentals to address scale-up challenges of this exciting modality and to enable medicines and vaccines to get to patients faster.”

It also highlights different challenges in sizing up from lab to GMP scale, the limitations at current commercial size, and possible desired future scales. This makes it a great tool if you are assessing and preparing for the scale-up process of mRNA manufacturing.

At an industry level, our paper can be used in discussions on scale-up challenges and their solutions, and guide conversations around the commercialization of mRNA manufacture.

“This article brings forth the joint knowledge and experience of multiple industry SMEs and leaders,” said Akhilesh Bhambhani, Head of the Drug Product Development – Technical Development/Technical Operations at Ultragenyx Pharmaceutical Inc. “It provides valuable insights and a high-level overview of mRNA/LNP processes starting from plasmid linearization to fill/finish operation as well as scale-up considerations.”

It discusses the approaches to manufacturing mRNA encapsulated in lipid nanoparticles (LNPs) across different unit operations for manufacturing drug substance / drug product. The mRNA/LNP product manufacture process flow map is split into four groups:

  • Plasmid linearization
  • mRNA manufacture
  • mRNA/LNP manufacture
  • Fill and finish through QA release.

Our paper was developed by experts in BioPhorum’s Cell and Gene Therapy RNA workstream to enable future discussions and accelerate the commercialization of mRNA therapies.

Want to join in?

For more information, download the paper here and contact our Global Change Facilitator Christine Boswell at christine.boswell@biophorum.com

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Advanced Therapy Medicinal Products

Advanced Therapy Medicinal Products support the quest for better and faster development of cell, gene and RNA therapies​ through connecting therapy developers, contract manufacturing, and testing organizations to gain an understanding and respond to the challenges faced by the advanced therapeutics industry.

Development Group

Development Group accelerates and improves the development process of biopharmaceutical medicines for the benefit of the patient. Replacing isolation with collaboration by providing a “safe” space where subject matter experts can work on sharing solutions and best practice on emerging industry trends, implementation of new technologies and common issues whilst ensuring their intellectual property and confidentiality is protected.

Drug Substance

Drug Substance advances excellence in drug substance manufacturing and testing, acting as an industry voice to accelerate technology adoption, implement post-approval change more rapidly and increase confidence in maintaining compliance.

Fill Finish

Fill Finish accelerates development and acceptance of sustainable world-class filling and packaging operations for drug product which meets the future needs of patients. Through innovative solutions resulting from the sharing of expertise, we can overcome common performance challenges and deliver on quality and regulatory compliance.

Information Technology

Information Technology accelerates digital maturity across the ​global pharmaceutical manufacturing industry.

Quality

BioPhorum Quality provides a dedicated, safe space for quality professionals from biomanufacturers and contract organizations to coalesce and enhance effective collaboration to address shared industry challenges.

Regulatory-CMC

Regulatory CMC brings leaders together who have a common goal – to improve access to medicines through innovation in the Regulatory ecosystem. It provides a dedicated space for strategic leadership and a coordinated industry voice, to move from divergence to convergence.

Supply Chain to Patient

Supply Chain to Patient transforms the performance of global pharmaceutical clinical and commercial outbound supply chains through industry collaboration by creating transparent patient-centric, resilient and agile E2E supply chains, that consistently deliver high-quality medicines ensuring an uninterrupted supply to patients.

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Supply Partner is a trusted advisory group and collaboration that is the engine for driving change across the global industry for all things relevant to the inbound supply chain. Addressing the challenges of complexity, resilience, cost, sustainability, and innovation.

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Sustainability enables the industry’s transition to a low carbon, circular future – supporting members to improve patient health while respecting the planet. We activate multi-disciplinary teams drawn from our network to deliver environmental sustainability improvements across the value chain.

Technology Strategy

Technology Strategy acts as one voice of the industry to define strategy, accelerate technology transformation and support technology translation and adoption. With a purpose of enabling the future state of flexible, resilient, sustainable end-to-end biomanufacturing.

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