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

Strain Development

Customized E.coli, Yeast, and Pichia strain development strategies.

Microbial Process Development

Leverage our experience to get the most from your process.

Microbial Analytical Development

Robust analytical development personalized for your drug product.