Process Development Service

Process Development Service

Profacgen is capable of providing process development service for our customers. We have extensive expertise in all aspects of upstream and downstream development of protein drug/product manufacturing process, which facilitates your preclinical drug development process. We guarantee the well-defined, scalable and reproducible processes of making successful protein products are undertaken in a commercially viable and regulatory compliant way.

Process Development Service

In general, Process Development service involves cell line development and selection, upstream process development, and downstream purification process development. At Profacgen, we can screen among production strains to select an appropriate cell line that will efficiently produce your drug candidate. We also develop processes to optimize high cell density fermentation, to increase protein product yield and manufacture product of the best quality in the most efficient way possible. Besides, our service aims to improve product recovery processes, as well as downstream purification steps. 

Our Process Development Service covers: 

  Cell line selection and characterization
  Cell line quality assessment
  Culture media evaluation and optimization
  Batch, fed-batch, or perfusion process development
  Seed train/inoculum development
  Scale-up and viral clearance

 

We have extensive experience and capability to design, develop, optimize and troubleshoot for all stages of process development with a variety of approaches.

 

Equipment & Capabilities:

  Multiple bioreactors from 1L to 20L in mammalian or microbial systems.
  Chromatography utilizing AKTA explore system.
  Filtration unites for downstream applications.
  Cell banking services for production and cryopreservation.

 

Please contact us for more details of our preclinical process development services. Our experts will provide and help design an optimal solution for your project and trouble-shoot for you throughout the whole process.

 

INQUIRY

  •   Email: info@profacgen.com
  •   Tel: 1-631-448-8149
  •   Fax: 1-631-938-8127
  •   45-1 Ramsey Road, Shirley, NY 11967, USA