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WINTER

01. WINTER. MS LAB. Template. MS LAB SYSTEM. About us. 02.

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WINTER

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  1. 01 WINTER MSLAB Template MS LAB SYSTEM

  2. About us 02 PMA – Pharma Marketing Advisors is a Bulgarian company specialized in marketing and consultancy analyses in the pharmaceutical industry. The company is registered in 2008. PMA’s team has great experience at preparing marketing strategies and studying the market for both local and international clients. Throughout the years, PMA has achieved considerable professional and organizational headway to organize and carry out laboratory analysis of the MS patients NAB-status in Bulgaria's leading MS center. We have developed a specially designated web-based software application set to provide operational management and quality control.

  3. The problem 03 • A potential problem with prolonged clinical use of recombinant human cytokines, including IFNb, is antibody induction. • So far it is impossible on the basis of clinical data to identify who eventually develop binding and neutralizing antibodies.

  4. The most dramatic effect of antibodies is seen in cases in wich the antibodies interfere whith the effect of endogenous hormones. This has been observed with the use of erythropoietin-alpha in patients with chronic renal failure, where several cases of pure red cell aplasia have been reported1. Recently, a case of a rare variant of malignant melanoma was reported in a patientwho had been NAB-positive for several years, and it was hypothesized that persistent NABs could be the associated potential for adverse effect resulting from the suppression of endogenous IFN-β activity2. • Casadevall et al. (2002) Pure red cell aplasia and antieruthropoietin antibodies in patients treated with recombinant erythropoietin. N Engl J Med 346: 469-475. • Gibbs E. et al. (2008) Malignant melanoma in a multiple sclerosis patient with persistent neutralizing antibofies to interferon-beta. Eur J Neurol 15: e4.

  5. 04 The solution Beyond technical performance of laboratory assays, the web-based software provides operational, communicational and informational environment for MS patients, health professionals and laboratory staff.

  6. 05 Results • Determination of binding antibodies and neutralizing antibodies to human IFNb: • 250 MS patients; • 417sera tests. Fig. 2. Drugs distribution. Fig. 1. Gender distribution.

  7. BAbs results We use the BÜHLMANN anti-IFNβ ELISA kit, which is designated for direct and quantitative determination of IgG antibodies to therapeutically administered IFNb in human serum. Table 1. Prevalence of BAbs in IFNb-treated patients.

  8. Buehlmann reference

  9. NAbs results We use the Biomonitor iLiteTM anti-human IFN-beta kit, which is designated for the semi-quantitative determination of neutralizing antibodies to human IFNb, using luciferase generated bioluminescence. Table 2. Prevalence of NAbs in IFNb-treated patients.

  10. Our vision

  11. WINTER MSLAB for your MS patients Template Make your Software controlled Laboratory Assays for BAbs and NAbs … ...in our MS LAB!

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