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
|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|
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.