Microbial Process Development Services

Microbial Process Development

Maximize the Performance of Your Microbial-Based Process

Team Cytovance leverages modern technologies and decades of experience to proactively tackle threats to development in both upstream microbial-based expression and downstream purification. Our goal is to help you get the most from your process and program investment.

Exceptional Process Development

With more than 84 different proteins expressed successfully in the past decade in both E.coli and yeast (Pichia or Saccharomyces) batch and fed-batch fermentation, we can develop robust, large-scale-capable fermentation processes in single-use or stainless-steel-based technologies. Using either the platformed Keystone Expression System^® or custom-engineered solutions for your molecule, in addition to proven soluble and insoluble protein refolding processes, our experienced team can ensure maximal productivity of your microbial process for scale-up.

Client Focused Service with Integrated Analytics

As your responsive CDMO partner, we leverage our experience and capabilities to fit our process to your molecule. From full-service strain and microbial process development or a facilitated timeline with the Cytovance Keystone Expression System^®, we can be flexible to fit your needs. Analytical support from our resourceful lab teams is seamlessly integrated to inform process development decisions and next steps with your dedicated program management team.

Ingenuity That Reduces Unpredictability

It takes skill and expertise to navigate a microbial molecule from concept to development. Through our experience in establishing the Keystone Expression System® and moving dozens of microbial projects to cGMP manufacturing, we have gained a thorough understanding of critical parameters in the microbial development process that can reduce unpredictability and increase productivity at a larger scale. The Keystone Expression System® coupled with our fermentation, refold, downstream, and analytical expertise, we keep your molecule moving forward and provide immediate solutions if surprises occur.

State of the Art Upstream and Downstream Capabilities

Being a leader in microbial-based recombinant protein manufacturing means that we have access to state-of-the-art technologies in both development and manufacturing. From small-scale Design of Experiment (DOE) based fermentation studies to progressive scale-up, we only utilize the latest harvest, purification, and analytical technologies from Beckman, Thermo Fisher Scientific, and other trusted brands, to enable the development of robust, large-scale microbial-based manufacturing processes.

Related Areas of Expertise

Strain Development

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

Microbial Analytical Development

Robust analytical development personalized for your drug substance or biologic.

Microbial Manufacturing

Benefit from our full-service cGMP facility with up to 1,000L microbial capacity.