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.
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.
Primary Packaging
Protect
Fill & Filtration
Freeze & Thaw
Cold storage
Ship, Track & Trace
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.
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 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.
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.
Fully automated filling & draining system of multiple small single use bags in cell & gene therapies at highest accuracy.
Fully automated filling & draining system. Up to 12 single use bags ranging from 50mL to 50L. Filling of 1000L 3D single use bags possible.
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 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.
Up to 400L of controlled freezing in the RoSS.pFTU large scale
Ultra-Cold Storage for frozen drug substances in different sizes. RoSS.FRDG keeps the desired set point temperature down to -80°C.
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 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.
