StAbilize™

against antibody aggregation

StAbilize™ Technology

The biotechnology industry has successfully manufactured human therapeutic antibodies that have transformed the treatment of disease. However, human antibodies developed to date often display undesirable properties in response to the non-physiological stresses placed upon them when produced in cell culture, purified to high concentrations and formulated as drugs. Development of human antibody therapeutics would therefore greatly benefit from technology that tackles their sub-optimal colloidal stability. This instability leads to the formation of aggregates, which are detrimental to the manufacturing process, storage and administration of antibodies.

At Solvanix we have developed StAbilize™ to improve the stability of human antibodies. The StAbilize™ process optimizes amino acids at specific locations within the antibody complementarity determining regions (CDRs). The result is a fully human antibody with significantly increased stability and a reduced propensity to aggregate that still retains all the properties necessary for therapeutic use.

StAbilize™ accrues benefits
at every stage in the developmental value chain

Developmental Stage

StAbilize™ Advantanges

Research and Preclinical Development Increased expression & stability of multivalent fragment Abs
Novel libraries with unique binding domains
 
Manufacture Rescue of very unique unstable candidates
Increased candidate pools & reduced risk
 
Upstream & Recovery Increased design space
Optimised for fed-batch & high concentration perfusion cultures
Increased expression & refolding of multimetric constructs
 
Downstream & Viral Clearance Simplified purification and viral clearance
Reduced cost (particularly for continuous manufacturing)
 
Clinical Increased stability and shelf-life
Reduced risk & cost
 
Commercialization Reduced or no cold-chain requirements
High concentration presentations possible and lyophilisation simplified
Increased shelf-life

 

Advantages of StAbilize™ technology:

  • efficient and cost effective manufacturing,
  • high concentration drug delivery,
  • increased shelf-life,
  • reduced formulation complexity,
  • improved cold-chain logistics, and
  • potential to reduce immunogenicity risk.

StAbilize™ can be used for all antibodies in development to improve characteristics and reduce the future manufacturing and commercial risk. StAbilize™ can also improve antibodies that would otherwise fail to meet manufacturability requirements. The technology is directly applicable to a wide range of antibody formats, including fragments, bi-specifics and full-length IgG monoclonals.

StAbilize™ can be rapidly implemented and tested using highly predictive methods, and can be applied to phage display libraries.

The technology has been validated by improving the stability of a broad range of currently marketed therapeutic antibodies as well as drug candidates while maintaining binding and other critical functions.