Microbial Manufacturing
Flexible cGMP Microbial Manufacturing for Product Life Cycle Management
From cell banking to 1,000L stainless steel fermenter runs, we have an unrivaled track record in cGMP microbial manufacturing. Coupled with phase-appropriate regulatory compliance and a dedicated program management team, Cytovance can support your product from the first patient to commercialization, all from our U.S.-based facilities.
Regulatory-Focused Microbial Manufacturing
Our cGMP end-to-end microbial-based manufacturing capabilities are unmatched in operational excellence and proven by our strong regulatory history. Beginning with the generation of both master and working cell banks, through seed train expansion to vessel production, to product purification culminating in bulk drug substance, all in compliance with FDA, cGMP, and ICH guidelines, our team’s commitment to patient safety and the success of our partners is a priority. We are confident that Cytovance’s operational excellence, seamless integration of quality controls, and dedication to regulatory compliance can efficiently steer your product to a successful filing.
Microbial Capacity in State-of-the-Art Facilities
To keep your molecule moving forward, we have a range of cGMP-qualified fermenter scales that provide flexibility around demand during varying stages of the product life cycle. To provide both speed and peace of mind, we perform a rigorous three-day turnaround on bioburden testing that streamlines sterilization methods.
Our manufacturing facilities house multiple scales of fermenters, in addition to stainless steel and single-use fermenters ranging from 14L to 1000L. When coupled with our teams’ unrivaled technical expertise and ingenuity with microbial fermentation and scalable refolding technologies, we can ensure maximal purity, potency, and yields for your microbial-derived product while maintaining the highest level of regulatory compliance.
Related Areas of Expertise
Microbial Analytical Development
Robust analytical development personalized for your drug product.
Contact Us
Meet Team Cytovance in 2026!
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– BIO Investment and Growth Summit: March 2-3, Miami Beach, FL
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– OPCU Large Molecule: March 24, Virtual
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– World Vaccine Congress: March 30-April 2, Washington D.C. | Booth 536
– PEGS: May 11-15, Boston, MA -
– TIDES USA Oligonucleotide & Peptide Therapeutics: May 11-14, Boston, MA
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– BIO International Convention: June 22-25, San Diego, CA | Booth 4445
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– BioProcess International East: September 22-25, Boston, MA
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– CPHI Europe: October 6-8, Milan, Italy
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– CDMO Live Americas: October 19-21, Boston, MA
- – OPCU Large Molecule: October 27, Virtual