Proprietary manufacturing process for a liquid IVIgG product - in great demand world-wide as one of the principal therapeutics obtained from blood plasma. Process delivers a low IgA content, which increases renal tolerability.

Liquid IVIgG is the product of choice in the market. The SNBTS product has a low IgA content and has been formulated to provide increased renal tolerability. The product has been found to be efficacious in clinical trials and, where comparative data are available, the adverse reaction profile is superior to liquid IVIgG products from other manufacturers

 

Methods of preparing liquid compositions for intravenous immunoglobulins, which are stable upon storage between 4 and 25C, without aggregation or degradation.

IgG usually prepared from human plasma.

Stable iv immunoglobulin solutions made using different pH and ionic strength conditions from those commonly used including, in addition, treatment with an enzyme such as pepsin.  Pepsin treatment at low pH also found to be an effective virus inactivation step.

The liquid immunoglobulin can be made using Cohn cold ethanol fractionation or other modified method

Patent Life

Expiry Date:            2017

Year remaining on Patent:            10 years

Supplementary Protection Certificate option: Yes.  An application for an SPC must be made within 6 months of obtaining Marketing Approval from the Regulatory Authority or Grant of the Patent (which was 18 February 2004), whichever is the later.
Patent Number: EP98909665.6

USA: 6,485,932 et al

Countries: Granted,

Austria, Germany, Spain, France, UK, Italy, Taiwan, USA.

Canada pending.

Partner Qualification Criteria

Requirement for high performance liquid IVIgG product.

Tasks to be Performed by Partner

Inwards technology transfer, addition of second virus inactivation step.

 

Support Provided by Your Organisation

Technology transfer support .