Monoclonal Antibodies (mAbs)

Safe Handling and Freezing/Thawing of Monoclonal Antibodies (mAbs)

Controlled processes play a vital role for monoclonal antibodies (mAbs) manufacturing processes. mAbs require special care and sensitive handling at every step of development and production, as well as in logistics, so as not to compromise their effectiveness. Additionally, controlled and fast freezing and thawing rates can add to improved levels of quality and lead to better overall results.

RoSS with frozen IRIS Bag (10 von 10)-min

Single-Use Technologies in Monoclonal Antibodies Production

Single-use technologies are highly flexible and scalable; thus, they offer the ideal solution for processing antibodies, cells and genes in a variety of volumes. 

The growing range of therapies and compounds calls for plants and systems that are or can be adapted to the increased speed of development and production as well as constantly changing requirements. In the case of monoclonal antibodies special focus should be put on viscosity: As a result of protein-protein interactions, concentrated mAb solutions can exhibit high levels of viscosity that may pose challenges during the manufacturing process.

Controlled Plate-Freezer_1

Scalable Single-Use Technologies for mAb 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.

RoSS.FILL - aseptic single-use filling and draining system for Cell & Gene therapies


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.

RoSS.pFTU large-scale

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

RoSS.pFTU large-scale

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 ROI of Bulk Freezing with Plate Freezers

The switch from cryovessels to plate-based freeze & thaw single-use technologies is, not least, a matter of costs. To determine the return on investment (ROI), different cost drivers were identified and evaluated. Discover the comparison of cryovessels, blast freezers and plate-based freezers in this case study.

Case Study_RoSS.pFTU_The ROI of Bulk Freezing with Plate Freezer

Case Study RoSS.pFTU: The ROI of Bulk Freezing with Plate Freezers

Filesize: 1.64 MB – Mime-Type: application/pdf

More information

Freeze-thaw technology for handlings mAbs on another quality level

Evaluating freeze-thaw processes in antibody production

In a field as sensitive as monoclonal antibody development and production, controlled processes and procedures have always played a vital role and will continue to do so. Learn more why Single-use technologies are highly flexible, scalable and on another quality level.


Scaling mAb production: From lab to large-scale

Scale-up has to be considered already in early stages of monoclonal antibody production. But what do manufacturers have to bear in mind? We'll find out in this article.

Filling of drug substance: 5 threats you should know

Trends in monoclonal antibody production: Optimizing processes with single-use technology

Several trends are re-shaping monoclonal antibody manufacturing – from the minimized use of in vivo practices to the implementation of automated processes. In this article, we will highlight 5 current trends in mAb manufacturing.


Solutions for automated aseptic filling of monoclonal antibodies

Filling monoclonal antibodies requires dedicated solutions that allow smooth and safe mAb processing. In this article, we will discuss some of the integral components in this procedure.

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Antibody storage: preserving monoclonal antibodies

In many cases, antibodies need to be stored for varying time spans before further processing or administration. Hence, it is essential to mind the characteristic storage requirements of these valuable biologics.