Bioconjugates Manufacturing

Bioconjugates represent a rising class of biopharmaceuticals in which at least one of the reactants is a biomolecule, often an antibody, protein, or oligonucleotide. The most famous example is the class of antibody-drug conjugates (ADCs).

ADCs comprise an antibody that is joined by a chemical linker to a biologically active drug or a cytotoxic compound. The monoclonal antibodies that make up the antibody component of ADCs can be carefully designed to target specific cells, such as tumor cells.



Safe Handling of Antibody-Drug Conjugates (ADCs)

Any breakage of sample containers holding ADCs or their cytotoxic components could pose a serious threat to staff safety. Careful handling and reliable protection are required throughout the entire production and logistics process. Single Use Support’s RoSS® shell (a robust shell system for frozen storage and shipping), comprising an outer sleeve of robust stainless-steel and an adaptive inner layer of 3D foam, forms a closed system around single-use systems and can contribute to the safe transport and storage of high-value and potentially harmful substances.

RoSS shell - Single Use Support

Scalable Single-Use Technologies for Bioconjugates


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.

Single use bag filling system 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.


More Information


Controlled freezing of ADCs

Antibody-drug conjugates might revolutionize the treatment of cancer and various other diseases. However, there are some challenges to overcome in their handling, including controlled freezing – find out more in this article!

Sterile bag filling - Single-use handling in biopharma on another level

Safe Filling & Aliquoting of Antibody Drug Conjugates (ADCs)

The safe handling of ADCs or other HPAPIs is a complex and elaborate process that requires specialized facilities and a safe, sterile environment. The filling/aliquoting step in particular calls for great care and specific equipment to ensure sterility and rule out any potential cross-contamination as well as potential harm to handling staff.


ADC manufacturing: Process, Challenges & Solutions

Scale-up and industrial production of ADCs face complications due to the high safety measures which need to be taken to guarantee product efficacy and a protected working environment for staff and manufacturers. In this article we seek out to give you an overview of the different challenges during ADC manufacturing while also introducing solutions which help to ensure aseptic production methods through single-use-technologies and end-to-end systems. 

Bioconjugates manufacturing with single-use technology

Bioconjugates manufacturing & the advances with single-use technology

The manufacturing of bioconjugates is a complex process that involves linking a drug payload with a targeting moiety using a linker. The process is highly specific and requires careful optimization to ensure that the bioconjugate is effective and safe for use in patients. Single-use technology has revolutionized the manufacturing of bioconjugates by offering a range of benefits over traditional stainless-steel manufacturing. Therefore, this article will pay special attention to this subject.