Single-use technology in mRNA manufacturing

BRMO

Brian Moloney

January 8, 2024

Table of contents

Show

As the demand for mRNA vaccines and therapeutics increases, the biotech industry needs solutions that enhance scalability and productivity. Single-use technology has emerged as a game-changer in this regard, making mRNA manufacturing more efficient and adaptable to surges in demand. Single Use Support has been at the forefront of this innovation, providing unique solutions to alleviate mRNA manufacturing challenges.

Advantages of single-use technology in mRNA production

Single-use technology has revolutionized the biopharmaceutical industry, and mRNA production is no exception. With the ability to drastically reduce contamination risks, streamline workflows, and scale up rapidly, single-use systems bring several advantages and have enabled the mass production of life-saving mRNA vaccines and therapeutics.

It is the flexibility of single-use technology which is a major contributor to the process development. Production lines can be quickly set up, scaled, or repurposed to meet urgent demands, enhancing productivity and cutting down the time from development to deployment.1 

Safe fluid management during mRNA manufacturing

MRNA products are sensitive formulations which require specific production modalities. This is not only because of low mRNA stability, but also due to special requirements of other sensitive components like LNPs that are used as mRNA delivery systems. The manufacturing process from plasmid DNA to mRNA formulation bears considerable risks of contamination, as well as product alterations. Fully automated and modular solutions by Single Use Support help to minimize human error during manufacturing and safeguard maximum product viability.

By using single-use bioprocess containers in combination with the aseptic filling and filtration system RoSS.FILL, fluid management does not only become safer, but easier to scale-up, depending on your project’s requirements and specifications.

RoSS.FILL - single use filling system for drug substances

RoSS.FILL | Fill-Filtration

RoSS.FILL is a fully automated single-use bag filling system. This allows maximum flexibility and scalability of both the filling and draining process. It is possible to fill unlimited volumes per batch with a speed of up to 300 liters per hour. The entire filling process is fully disposable, thus warranting an absolutely sterile fill & drain process. For further productivity improvements check out our pinch valve innovation.

App Note: The Chilled Future of RNA Therapeutics Filling & Freezing Applications

Traditional and rigid manufacturing processes are not for Advanced Therapies. Since novel therapies push limits in biotechnology, life science needs to keep up with adequate process solutions around commercialization of these specific therapies. Yes, SARS-CoV-2 has largely boosted the acceptance of mRNA in vaccines. And RNA vaccines and therapeutics won’t stop to fulfil unmet medical needs. But biotechs and biopharma companies continuously advancing novel treatments while solution provider drive process optimization to increase efficiency. With different product characteristics come different challenges and risks for fluid management. Therefore, modular, and flexible technologies facilitate ATMPs (Advanced Therapy Medicinal Products) manufacturing. Adjustability of process solutions to different requirements and scenarios will satisfy the needs of biomanufacturing and biotechnology companies as well as CMOs and CDMOs along the journey from drug development to commercialization.

Advanced cold chain solutions for mRNA manufacturing

Preserving the integrity of mRNA and deriving products also implies paying tribute to their high requirements in terms of temperature control. Especially for longer storage, ambient temperature is not suitable for mRNA products, which would quickly deteriorate.

Consequently, one of the biggest challenges when handling mRNA products is the continuous cold chain. To achieve this, we rely on plate-freezing, which in comparison to other freezing methods minimizes the risk for protein denaturation through even freezing at -80°C.

Nevertheless, control is key in the ultra-cold freezing process of mRNA. With adjustable cooling rates and single-use bioprocess containers that can withstand the physical stress of extremely low temperatures, Single Use Support’s freezing platform RoSS.pFTU helps to optimize mRNA manufacturing and processing.

Following ultra-cold freezing processes, mRNA can be prepared either for further processing, storage, or transport.

Single-use technology in mRNA manufacturing

Storage and transport of mRNA products with single-use technologies

Achieving ultra-low temperatures is not enough to preserve mRNA products from deterioration: Maintaining these temperatures is just as essential when preparing the valuable goods for storage and transport.

Yet again, single-use technologies have proven to be a viable option to fulfill this task: Single Use Support’s ULT storage freezer RoSS.FRDG is ready to provide stable temperatures as low as -75 °C. With storage density as an additional focus to maximize scalability as well as efficiency, the storage freezer offers space even for large amounts of mRNA products, filled in single-use bioprocess containers and safely protected by RoSS® Shell.

This single-use bag protection brings additional safety to mRNA manufacturing, storing, and transport, the latter of which is further simplified by RoSS.SHIP – a cold chain shipping container able to keep drug substances at temperatures below -60 °C for at least six days. However, this is just one puzzle stone in the product portfolio of Single Use Support that has been established to optimize mRNA manufacturing based on single-use technologies.

Freeze-thaw technology for handlings mAbs on another quality level

Freeze & Thaw platform

The Single Use Support freeze-thaw platforms provide insular solutions for the freeze/thaw processes of each clinical phase. Our new freeze-thaw units are fully scalable and compatible with all batch sizes and bags from all established manufacturers – you will only require one single system from the lab to blockbuster production.

FAQs about mRNA manufacturing

What is mRNA manufacturing?

mRNA manufacturing involves the production of messenger RNA (mRNA) for use in vaccines and therapeutics. This revolutionary technology has shown immense promise in the biotechnology industry, particularly in vaccine development, where it has significantly shortened development times and improved scalability.

What are the steps involved in mRNA production?

mRNA production steps include in vitro transcription, capping, synthesis of mRNA, and mRNA purification. The process is relatively simple, scalable, and fast, making it a promising approach for vaccine and therapeutic production.

What challenges exist in mRNA drug manufacturing?

Key challenges in mRNA drug production process include scaling up production to meet global demand, maintaining strict temperature control throughout the manufacturing process, ensuring aseptic conditions, and implementing rigorous quality control measures to ensure the final product's safety and efficacy.

How can single-use technology contribute to the production of mRNA?

Single-use technology enhances mRNA production by improving scalability and productivity. For instance, Single Use Support offers automated closed systems that optimize processes, protect drugs and biologics from temperature fluctuations, and fulfill cGMP regulations.

  1. Enhancing mRNA vaccine production efficiency with Single Use Technologies, https://www.thechargepoint.com/news/mrna-vaccine-production-efficiency-single-use-technology/, Published 2022
BRMO

Brian Moloney

Chief Commercial Officer (CCO)

Brian Moloney is Director New Products & Innovation at Single Use Support. With this role he is responsible for the development of new and existing products to further enhance innovation for the biopharmaceutical industry. Based on his extensive expertise as service, product and project manager at GE Power, Brian is now market expert in pharmaceutical fluid management. He has joined Single Use Support in 2021.

Find articles from Brian Moloney on Medium: https://medium.com/@brian-moloney

More from Brian Moloney

Vaccines

Fluid management solutions for biosimilar production

In biosimilar production, fluid management takes on an overarching role, as it is encountered at several manufacturing steps. This is all the more reason to deal with efficiency in fluid management – which we will do in this article.

BRMO

Brian Moloney

May 14, 2024

Vaccines

Challenges in manufacturing biosimilars

The manufacturing process of biosimilars is a complex endeavor, accompanied by several challenges. We will discuss some of the biggest hurdles in this article, along with solutions to overcome them.

BRMO

Brian Moloney

May 14, 2024

Read more about mRNA & LNPs

mRNA & LNPs

What is mRNA?

mRNA is the acronym for messenger ribonucleic acid – but there is much more to know about this fascinating molecule, as it is essential in elementary biological processes. In this article, we will give readers a brief explanation of what mRNA actually is and discuss its application in medicine as well as recent advances in mRNA technology.

micheal-eder

Michael Eder

July 6, 2023

mRNA & LNPs

The function of mRNA

In order for the genetic information encoded by DNA to become an accessible blueprint for protein production, mRNA is indispensable. In this article, we will provide a comprehensive definition of mRNA and illustrate its main functions.

micheal-eder

Michael Eder

July 6, 2023

mRNA & LNPs

mRNA cold chain: considerations & solutions for safe handling

Meeting the temperature requirements of mRNA-based products is essential to maintain product efficiency and safety. Effective mRNA cold chain management is necessary, but comes with several challenges. In this article, we will discuss relevant considerations and innovative solutions in mRNA cold chain management.

micheal-eder

Michael Eder

July 5, 2023

mRNA & LNPs

mRNA Manufacturing – The 5 process steps of mRNA production

mRNA is a fundamental component of several biological processes, and its unique properties are used in different fields of medicine and research. mRNA manufacturing, however, is a complicated endeavor. In this article, we will take a detailed look at mRNA manufacturing and the advantages that come with single-use technologies.

daniel-tischler

Daniel Tischler

July 5, 2023