Contract Manufacturing Services

A Service minded, adaptable and agile team

Captozyme’s client services division acts as a Contract Manufacturing Organization (CMO) for our partners.

Since 2009 we have been developing live biotherapeutic products (LBP’s) and performed technology transfers to multiple CDMO’s globally. Using our broad process knowledge and experience we have constructed a best in class third party audited cGMP (current Good Manufacturing Practices) manufacturing facility for the production of LBP’s for first in human clinical studies. 

The team is highly skilled in working with strict and fastidious anaerobes and is experienced in a wide scope of genera and species presenting a very competitive advantage in a growing market.

our manufacturing facility

Captozyme’s expertly designed cleanroom and manufacturing facility is built for the biomanufacturing of any type of LBP, whether that be obligate, facultative or microaerophilic organisms. Our cleanroom includes an ISO 8 fermentation room, ISO 8 blending room and ISO 7 lyophilization suites.

The facility serves both internal development objectives as well as external clients.

our Services

Captozyme’s service lab works to be an extension of our clients’ team, and are committed to transparency and teamwork. We offer both cGMP (current Good Manufacturing Practices) manufacturing services and process development services.

Our cGMP Services include:

  • Cell banking (MCB, WCB)

  • Frozen blend

  • Drug substance (lyophilized active powder)

    • Fermentation

    • Filtration

    • Lyophilization

    • Packaging

  • Media production

Our non-GMP services include:

  • Cell harvest development

  • Formulation development

  • Lyophilization development

  • Sieving and packaging

  • Quality testing for food ingredients, supplements, and drug substances

Contact us today if you have any questions or would like to request a quote.