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.
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.
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
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.
Fully automated filling & draining system. Up to 12 single use bags ranging from 50mL to 50L. Filling of 1000L 3D single use bags possible.
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.
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.
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.
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.
Learn more about navigating the 5 most overlooked challenges in microbial and mammalian fermentation with regards to fluid and cold chain management challenges:
¹ Source: https://www.researchandmarkets.com/reports/5633632/global-precision-fermentation-market-by
