Synthecon, Inc. now offers cGMP contract manufacturing services in conjunction with a top quality manufacturing partner. These services focus on three areas: Secreted mammalian pharmaceuticals, including production of therapeutic proteins Monoclonal antibody production Vaccine Production

 

Production technology is based upon Synthecon's RollerCell 40T, a new cell culture system for the production of biopharmaceuticals. The RollerCell 40T is a self-contained, automated roller bottle processing system.

A single RollerCell 40T production unit can process the equivalent of 200 standard roller bottles simultaneously... producing:
. dramatic savings in labor related costs
. virtual elimination of handling associated with media changes
. minimal handling-related risk of contamination

Our manufacturing partner operates a licensed facility under both the Center for Biologics Evaluation and Research (CBER) and Center for Devices and Radiological Health (CDRH) guidelines, and is in good regulatory standing with both. In addition to cGMP manufacturing, customers have availability to monitored cGMP cleanrooms for dispensing product into vials as well as clinical packaging and/or final product configurations. When needed, R&D staff is available on-site to assist customers with drug development and regulatory direction.

Drug development typically follows a scale-up of product requirements as the drug candidate develops from pre-clinical to clinical and finally, to commercial requirements post-marketing approval. The RollerCell 40T unit provides unique flexibility to expand capacity while maintaining high utilization. As your product requirements increase, we simply commit more units to your production. This flexibility avoids comprising utilization and efficiency in the early stages of your product requirements, and similarly, provides an orderly increase in production without disrupting product output as product requirements reach high volume levels associated with commercialization.

We follow a detailed checklist of steps when taking on your cGMP contract manufacturing project. Our team works closely with potential customers to ensure a smooth and steady transition to cGMP of your product. Regulatory and record keeping for key compliance requirements is one of our highest priorities, ensuring production runs are smooth and interrupted.