Process Development /

Upstream Process Development (USP)

USP development

USP process development includes a wide spectrum of scientific research and development. Process development includes, but is not limited to:

  • Cloning and sequencing of target genes. Depending on gene variety and requirements of future products, various approaches to gene cloning are applied, including custom gene synthesis, fused genes and target mutagenesis.
  • Development of effective producer strains. Our experience in biosynthesis processes allows us to develop bacterial, yeast and mammalian strains with stable expression levels.
  • Construction and GMP-storage of microbial and mammalian cell banks.
  • Biosynthesis process development aims to reduce the costs, risks and timelines for projects entering GMP manufacture. We use in-house knowledge to design a GMP compliant process for biosynthesis of bacterial, yeast or mammalian cultures.

We have gene engineering methods for expression systems development in microbial, yeast and mammalian cell cultures. Cloning includes but is not limited to site-directed mutagenesis, gene fusion, subunit cloning. Genetic constructions are cloned with expression optimization along with strain selection. Clone selection is followed by primary analysis of biosynthesis conditions. Protein expression is assayed using polyacrylamide gel electrophoresis and Western blotting methods, accompanied by ELISA assays.

Our upstream process development group is developing high cell density E. coli batch and fed-batch processes for therapeutic recombinant proteins and monoclonal antibodies produced from mammalian cell cultures. Our approach is flexible, and based upon our clients’ needs. Bioreactors (Applikon) 3 – 15 L of working volume are used for process development activities and clone selection is caried out by FACS.