Cold Chain Handling for Microbial & Bacterial Fermentation

Microbial, bacterial and mammalian cell fermentation are processes performed during media and drug development for the production of biologics, especially vaccines. Smaller biologics, such as antibody-drug conjugates and small antibody and peptide fragements are mostly manufactured with microbial and bacterial fermentation. Product quality, process control and safety are key criteria in current good manufacturing practices (cGMP) of upstream bioprocessing. Ultimately, the fermentation aspires to support cultivation of microorganism to achieve high-cell density and high productivity in final culture generation.

Bioprocessing Downstream

Microbial and Bacterial Fermentation Manufacturing

Bacterial and microbial fermentation form the field of precision fermentation. They are building blocks for gene-editing, conjugations and DNA plasmids which are all crucial elements in improved vaccine production. With an estimated market volume of $ 36bn by 2030 this opens up new possibilities in advanced therapies¹.

The challenges to be overcome in pharmaceutical fermentation development are to promote growth rate, cell viability and productivity. Associated fermentation process steps include sizing the ferment, activating polysaccharides and supplementing media to help stabilize the drug substance before the final conjugation can be completed. For improved fermentation production, manufacturing sites must be equipped with scalable, cost-effective and robust process solutions for large volumes up to hundreds of liters per batch.

Quick Freezing & Thawing of Large Volumes for Fermentation in Pharma

Ensure High Product Potency during your Cold Chain

Whether continuous or fed-batch manufacturing, using microbial or bacterial fermentation processes, large volumes of process intermediates may be transported in bulk for completion and final conjugation and further clinical manufacturing in the area of gene-editing, plasmid DNA, antibody-drug conjugates and vaccine manufacturing. 

Discover the flexible end-to-end process solutions from Single Use Support for advanced fluid management and freeze-thaw logistics involving single-use technolgies: Fast aseptic automated aliquotation into single-use bioprocess containers and controlled freezing to -80°C in less than 8 hours. Further solutions for ultra-low temperature storage, shipping, thawing and draining. 


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


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-7


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

Freeze & Thaw


Controlled freezing and thawing of thousand of liters in biopharmaceutical manufacturing processes. Automated plate-based freeze-thaw unit for 400 liters per batch of any liquid substances including vaccines, media, buffer solutions or other drug substances.

RoSS.pFTU XL_Product Overview-2-min (1)

RoSS.pFTU Mid 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 Mid Scale is the perfect solution for few single use bags of up to 100L. GMP-compliant computerized system optional and easy transferal to larger systems.

Plate freezer biopharma with RoSS.pFTU midscale

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.


Learn more about navigating the 5 most overlooked challenges in microbial and mammalian fermentation with regards to fluid and cold chain management challenges:

  • Advanced Bulk Plate Freezing replacing Spray Drying
  • Protection of Bags Reduce Product Loss
  • Scalability in Yeast, Bacterial or Fungal Fermentation
  • Speed of Large Volume Filling and Freezing
  • Integrated End-to-End Logistics in Continuous Production
Guide-Navigating 5 Overlooked Challenges in Biopharmaceutical Fermentation_Single Use Support

Navigating 5 Overlooked Challenges in Biopharmaceutical Fermentation

Filesize: 2.98 MB – Mime-Type: application/pdf

More Information

Single-use solutions for Microbial Production

Microbial Fermentation Manufacturing: Advances through single-use technologies

Microbial fermentation is a powerful, flexible microbiology process used to generate microbial cells or biomass such as proteins and enzymes for the production of vaccines and therapeutics. There are still some challenges to overcome. Many of these challenges in fermentation manufacturing can be solved by replacing traditional systems with single-use technologies. 

Microbial Fermentation simply explained

Microbial Fermentation simply explained

Microbial fermentation is a biochemical process that manages to extract chemical energy from carbohydrates without the oxygen. 

This chemical reaction occurs in bacteria, yeasts or even in muscles of humans. Read more details!


Fermentation in the pharmaceutical industry: A complete guide

Fermentation in the pharmaceutical industry is used to cultivate microorganisms for antibiotics, therapeutic proteins, enzymes and insulin. It typically involves temperature-controlled tanks, also known as fermenters and the correct concentration of nutrients to cultivate the desired organism. Microbial and bacterial fermentation technology and the associated processes open new possibilities and are important building blocks for gene-editing, conjugates and DNA plasmids used in modern vaccine production.

Differences between microbial fermentation & mammalian cell culture

Differences between microbial fermentation & mammalian cell culture

Microbial fermentation in bacteria, yeast or fungi is, due to its benefits, preferred in the production of smaller biologics. These include peptides, proteins, cytokines, growth factors, plasmid DNA, single-domain antibodies, peptibodies and more. Continue reading...!

Bulk drug substance management by Single Use Support

Bulk drug substance management

The following article aims to take a closer look at the term “bulk drug substance” and its meaning, as well as to investigate smart solutions to shorten the phase between development and blockbuster production. Read more about the solution for the biopharmaceutical industry!

¹ Source: https://www.researchandmarkets.com/reports/5633632/global-precision-fermentation-market-by