In vitro Glycoengineering of Therapeutic Proteins

Variation in glycosylation can impact the safety and efficacy profiles of a therapeutic product. With the right tools, glycosylation management can be uncoupled from the entangled processes of fermentation. Isolating glycosylation management from fermentation separates strategies to optimize glycosylation and yield, granting greater control over each.

Instead, certain glycoforms can be enriched in downstream processing using discrete enzymatic reactions with clear kinetics and predictable outcomes. No more resources wasted on uncertain tweaking of the bioprocess, leading to faster development as well as improved control of the manufacturing process.

Gains from in vitro glycoengineering

  • Time- and cost-saving generation of glycan variants to develop improved drugs
  • Optimized glycosylation without compromising other CQAs or product yield
  • Improved lot-to-lot consistency to reduce risk of product quality variation and resulting delays
  • Generation of glycoprofiles which may not otherwise be generated
  • Streamlined analytics in comparability studies



In vitro glycoengineering of therapeutic proteins

 

 

 

The tools to steer glycosylation

The CustomBiotech in vitro glycosylation toolbox is a portfolio of well-characterized enzymes and activated sugars designed for specific and efficient alteration of sugar moieties.

Developed in partnership with Roche Pharma to meet quality and manufacturing requirements of the biopharmaceutical industry, the toolbox is the product of an ongoing, innovative program aimed at facilitating controlled manipulation of glycopatterns.

The glycosyltransferases and glycosidases in the portfolio have demonstrated high activity on a variety of glycoproteins, meet stringent pharmaceutical standards, and are available in gram to kilogram amounts and good manufacturing practice (GMP) quality upon request.

Glycosyltransferases optimized for each drug development phase

  • Glycosyltransferases for research, available in small amounts (mg)
  • Glycosyltransferases of enhanced quality (EQ) for drug development:
    • low levels of host cell impurities
    • available in gram scale
    • GMP quality on request