Business can also be established by developing, manufacturing and selling a range of niche recombinant human proteins for use in Diagnostic Quality Control sera in theMiddle Eastand European markets. Diagnostic quality control sera providers and companies marketing diagnostic test kits, in the vast majority of instances, currently extract human proteins from blood plasma (donated from blood banks), process and formulate for use as quality control sera for laboratory tests.
There are a number of problems with this scientific and business model:
- Currently supply of material is limited and unstable;
- Sourcing human plasma for extraction is difficult due to blood bank restrictions and new regulatory requirements which has led to a shortage and therefore increased prices;
- Very little control on production capacity;
- No control on ability to incorporate new proteins in relation to novel biomarker identification.
Currently, C-reactive protein (CRP) tests are used to check the level of CRP in the serum/plasma of a patient to ascertain if there is any inflammation in the body irrespective of the location within the body. CRP tests are one of the key general indicators assessed by doctors for illness. In order to ensure that the diagnostic tests are working correctly, known samples are also tested with the patient’s samples (quality control material).
Diagnostic quality control sera providers and companies marketing diagnostic test kits require recombinant proteins at gram scale for use in the quality control sera of in vitro diagnostic test kits. The production process will entail scale up, partial purification, stabilization, quality control, packaging and distribution to our customers. Our customers will be diagnostic quality control material providers and companies marketing CRP ELISA test kits.
Recombinant CRP strengths includes
- No requirement to source blood with high CRP level
- Production costs significantly reduced
- Complete control over scale
- No regulatory bottlenecks
- No pre-testing required as in case of CRP extracted from blood for HIV or other relevant diseases.
Additional products for inclusion in QC material for tests which have a sizeable market are rheumatoid factor protein which is used as a marker for rheumatoid arthritis. Once established we will be in a unique position to rapidly respond to emerging pathological findings linking biomarkers to specific disease or treatment response time, etc.