Protein Expression Services

We have extensive experience with DNA plasmids and a variety of systems used for the production of recombinant proteins. Our services are custom-tailored to meet the needs of industry, academic and government researchers. Each project is uniquely designed depending on the clients needs, resources and ability to collaborate. We can assist one or more steps in the process or serve as the R&D team.

Our Services Encompass:

  • Gene cloning and vector construction

  • Clone screening and selection

  • Strain development and expression optimization

  • Strain improvement and expression enhancement

  • Cell bank preparation and characterization

  • Bioreactor fermentation production and optimization

  • Purification process development

  • Analytical assay development

  • Product characterization for identity, purity and potency

  • Formulation and stability analysis

  • Bench- and up to pilot-scale production

  • Technology transfer to cGMP facilities

  • Oversight at cGMP site during manufacture

  • Preparation of CMC documents and consultation for IND filing

Equipment:

 

  • Multiple bench-scale fermentation equipment

  • Multiple analytical HPLC systems

  • Multiple preparative LC system

Level of Service:

 

  • Comprehensive Service - provides expert research for production and purification of recombinant and native proteins, from subcloning to producing finished product.

  • Expression Service - provides from 10 to 100 mg of purified proteins where protein expression has been demonstrated but the process has not yet optimized.

  • Production Service - aimed at those who need more than 100 mg and where the process has been optimized for production.

  • Technology Transfer Service - preparation of technology transfer package for implementation of developed process (fermentation and down stream purification) at large scale site.

  • Analytical Assay Service - establish analytical assays for product, including SOPs, preparation of a transfer package for implementation at large scale site.

  • Assay Development Service - develop stability indicating assays, potency assays, immunogenicity and antigenicity assays with complete documentation and transfer package for implementation at site of choice.

  • Stability Program Service - advice and development of stability program for IND directed and Clinical Phase studies.

  • DNA Plasmid Service - provides expert research and development for design and production, advice and consultation for IND filing.

  • Optimization Service - for clients with very low levels of expression.