Fermentation

FERMENTATION

Scientist in cleanroom suit inspecting bioprocessing equipment in a GMP-compliant pharmaceutical manufacturing facility.

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.

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 PharmaEnsure 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.