Fermentation

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

Microbial and bacterial fermentation open up new possibilities in advanced therapies. They are building blocks for gene-editing, conjugations and DNA plasmids which are all crucial element in improved vaccine production.

The challenges to be overcome in 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. 

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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 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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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.

RoSS.FILL Bag - aseptic single-use bag filling and filtration system for drug substances

Freeze & Thaw

RoSS.pFTU Large Scale

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.

Pharmaceutical freezer RoSS.pFTU large scale freeze thaw platform
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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

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

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!

Simplyfication for optimizing performance efficiency with single-use technologies

Single-use end-to-end solutions - flexible, scalable and reliable

In an extremely complex, competitive and constantly evolving sector such as the biopharmaceutical industry, flexibility is key, not least since it is an immensely varied and compliance-driven field. Learn more in this article!

Upstream processing with single-use systems

Upstream processing with single-use systems

The manufacturing process of biopharmaceuticals such as monoclonal antibodies, mRNA and bioconjugates is divided into upstream and downstream processing. Manufacturers seeking reliable automation and optimization fit for scale-up are increasingly employing single-use bioreactors, titers, filtration and other components, especially during upstream.