Messenger RNA (mRNA)

mRNA Manufacturing Solutions

Temperature plays a key role in the Messenger RNA (mRNA) supply chain, as single doses biotherapeutics or vaccines must be kept at temperatures similar to those used in their clinical trials: -70°C (-94°F). To make the cold chain, which is often not designed for such low temperatures, continuous, it is necessary to optimize processes to protect drugs and biologics from temperature fluctuations.

RoSS.FILL CGT_Product photo (26 von 26)

mRNA Process Overview

From Production & Purification to Formulation & Filling, there are several process steps that are involved in the manufacturing process of mRNA. These include aliquotation & filtration, freeze & thaw, ultra cold storage and shipment.

mRNA-Manufacturing Prozess

Scalable Single-Use Technologies for mRNA Processes


Primary Packaging

Single-use bag protections system with RoSS shell


Single-use aseptic bag filling machine RoSS.FILL

Fill & Filtration

Plate freezer Biopharma large scale with RoSS.pFTU

Freeze & Thaw


Cold storage

Shipping drug substances in single-use bag containers safely with RoSS.SHIP

Ship, Track & Trace

Primary Packaging

IRIS Single-Use Bag (2D or 3D)

Store and ship anything from cell culture samples to large drug substance volumes reliably and on time. 2D or 3D single-use bioprocess containers in any size.

Single-use bioprocess container by Single Use Support


RoSS® Shell

With the RoSS Shell system, the sensitive single use bag is covered in 3D foam, which is held by a highly robust plastic frame. Bottom and top are made of stainless steel – ideal for the freezeing process and absolutely robust.

RoSS shell protecting single use bags open


Single use bags with a volume of less than 250ml are covered with a first layer of soft 3D foam which is complemented by an innovative and intuitive locking mechanism. Its robust stainless steel frame protects the single use bag during freezing and shipping.

Industry 4.0 biomanufacturing RoSS.KSET for CGT bag protection

Fill & Filtration


With RoSS.FILL, the RoSS shell systems contained in the bag rack can be filled with a speed of up to 300 liters per hour in a fully automated manner. RoSS.FILL is compatible to all single use bags and bottles and can be scaled up by attaching multiple racks.

Aseptic bag filling machine RoSS.FILL


Fully automated filling & draining system of multiple small single use bags in cell & gene therapies at highest accuracy.

Automated filling and draining system for CGT - RoSS.FILL CGT


Fully automated filling & draining system. Up to 12 single use bags ranging from 50mL to 50L. Filling of 1000L 3D single use bags possible.

RoSS.FILL Base_Product Photo-8

Freeze & Thaw

Freeze Thaw Platform

The freeze & thaw system RoSS.pFTU is a fully automated and scalable plate-based freezing unit. Both economically and in terms of product stability we have reached the next level. The plate-based platform RoSS.pFTU Large Scale is completely adapted to RoSS shell system for a batch sizes of up to 400L and more.

Controlled Plate-Freezer_1

RoSS.pFTU Lab Scale

Controlled freezeing and thawing of small batches - more important than ever for cell & gene therapies and clinical studies! The plate-based freeze & thaw platform for labs RoSS.pFTU Lab Scale is the perfect solution for one or multiple single use bags of up to in total 10L. GMP-compliant computerized system optional.

RoSS.pFTU Lab Scale_Product Photo

RoSS.pFTU Large Scale

Up to 400L of controlled freezing in the RoSS.pFTU large scale

Plate freezer biopharma large scale freezing with RoSS.pFTU largescale

Cold storage

RoSS.FRDG | Cold Storage

Ultra-Cold Storage for frozen drug substances in different sizes. RoSS.FRDG keeps the desired set point temperature down to -80°C.

Ultra-cold storage RoSS.FRDG

Ship, Track & Trace


RoSS.SHIP offers the your tailored solution for 100% protection from external mechanical influences for RoSS shell systems. Different possible sizes will fulfil your individualized need. With passive cooling, it maintains its ultracold temperatures for international shipments over multiple days. With its measurements it complies with international logistcis standards. Also monitoring temperature and tracking its location is no problem.


The Chilled Future of RNA Therapeutics Filling & Freezing Applications

The fluid management process for mRNA, LNPs, pDNA and viral vectors for cryopreservation are often performed manually and in an uncontrolled manner. As a result, they are prone to inefficiencies and increased product loss. Learn how modular and flexible single-use technologies optimize the manufacturing process in the App Note.

App Note_RNA Therapeutics Filling Freezing Applications

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

Filesize: 0.84 MB – Mime-Type: application/pdf

More Information


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Being promising tools in life sciences and medicine, lipid nanoparticles are drawing attention on their manifold advantages. In this article, however, we take a step back and discover how LNPs are produced. Solutions based on single-use systems for increasing quality and efficiency in production are also covered. 

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As the demand for messenger RNA-based products continues to rise, efficient fluid management plays a crucial role in ensuring the high-quality production of mRNA drug products. This article is about challenges and the latest advancements in fluid management techniques, focusing on filling, filtering, and aliquoting mRNA during the manufacturing process.

Freezing mRNA: best practice

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Considering the manifold applications of mRNA, it is essential to establish optimal freezing processes that maintain viability and effectiveness. In this article, we will compare different freezing methods for mRNA.

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