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.

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mRNA Process Overview

Production & Purification: Plasmid DNA

Production: mRNA

Formulation & Fill-Finish

  • Encapsulation
  • Flow Filtration
  • Final Fill

Scalable Single-Use Technologies for mRNA Processes

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Primary Packaging

Single-use bag protections system with RoSS shell

Protect

Single-use aseptic bag filling machine RoSS.FILL

Fill & Filtration

Plate freezer Biopharma large scale with RoSS.pFTU

Freeze & Thaw

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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

Protect

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.

Single use bag protection for drug substances in bulk stream with RoSS shell by Single Use Support
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RoSS.KSET

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

RoSS.FILL Bag

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.

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RoSS.FILL CGT

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

RoSS.FILL CGT
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RoSS.FILL Base

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

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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.

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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.

Laboratory freezer RoSS.PFTU Lab Scale
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RoSS.pFTU Large Scale

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

Pharmaceutical freezer RoSS.pFTU large scale freeze thaw platform

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

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.

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More Information

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mRNA vaccines: How to safely ship and store them

mRNA vaccines require high diligency along their supply chain. This is why every step in the mRNA vaccine supply chain must be carefully planned, carried out in a safe and controlled manner and requires appropriate, innovative technologies.