Wednesday, December 27, 2017

Kit performance of the SHIKARI Q-TRAS ELISA kit for measuring trastuzumab in serum/plasma samples.

Therapeutic Drug Monitoring (TDM):

Therapeutic Drug Monitoring of biologicals drug’s usefulness is now accepted in the light of published work from various clinical trials.  Several algorithms for TDM have been published when using biological drugs.  By TDM, effective use of biological drugs such as infliximab and adalimumab have been increased for the benefit of the patients and found to be cost-effective as well and the same applies for the other biological drugs as well. Apart from the clinical usage of biological drug testing also it is important for PK and measurements and immunogenicity testing for especially for pharmaceutical companies which are developing biosimilar drugs. Accurate measurement of biological drug trough levels and antibody to biological drug gained high importance during the course of treatment.














Matriks Biotek®, founded in 2002, is the first manufacturer of the market for therapeutic drug monitoring in its category with 10 years of experience. Matriks Biotek® “Shikari®” ELISA kits for trough level and anti-drug antibody measurement ELISA kits can be efficiently used, for monitoring serum trough levels and the presence of anti-drug antibodies respectively, during therapy and offers the scientist a tool for taking decisions on possible preventive measures. Our products are produced under ISO13485 quality standards and have CE-IVD mark for Europe.


Matriks Biotek® has 39 SHIKARI®  ELISA kits for 15 biological drugs (TNF blockers, anti-cancer drugs and others) on the market and also offers custom ELISA kits for biosimilar drugs for PK and anti-drug antibody detection and confirmation. SHIKARI® kits have been used in a total of 71 publications; 51 peer-reviewed journal articles, 3 patents, 3 Ph.D. Thesis and 11 presentations. Please find enclosed our current product list and list of publication as PDF.
http://www.matriksbiotek.com/
http://www.matriksbiotek.com/publications.html
order@matriksbiotek.com (ask a quote or give a purchase order)

Thursday, November 23, 2017

Three new SHIKARI® ELISA kits for semi-quantitative measurement of total anti-drug antibodies to infliximab , infliximab-biosimilar CT-P13 and adalimumab

We have been in the field of medical biotechnology for 15 years. As we are the first company to bring biological drug monitoring kits to the market for clinical laboratories, clinicians and their patients and pharmaceutical companies who have been used and/or using our products with confidence since 2008. Until now a total of 36 kits for 15 biological drugs have been brought to the market and our SHIKARI ELISA® kits have been used in 71 scientific papers.

Matriks Biotek® is committed to research and development in addition to advancing product innovation at every turn. As a result of these; Our products on the market are consistently increasing. We have recently completed 3 new products for screening total anti-drug antibody to infliximab (Remicade), infliximab biosimilar CT-P13 (Remsima/Inflektra) and adalimumab (Humira); SHIKARI Q-ATI Total, SHIKARI S-AIR Total and S-ATA Total respectively and will be launched on coming days.


Visit our website for information about all of our products www.matriksbiotek.com
Ask information from info@matriksbiotek.com or a quote from order@matriksbiotek.com 











Specifications of the tests:





Saturday, October 7, 2017

PUBLICATIONS SHIKARI® ELISA KITS: Updated October, 2017



Used in total of 69 publications; 49 peer reviewed journal articles, 3 patents, 3 Ph.D. Thesis and 14 presentations

www.matriksbiotek.com



1.            Ohem J, Hradsky O, Zarubova K, Copova I, Bukovska P, Prusa R, Malickova K and Bronsky J. Evaluation of Infliximab Therapy in Children with Crohn's Disease Using Trough Levels Predictors. Dig Dis. Aug 18, 2017.

2.            Al-Karkhi MA, Al-Ani MM, Jassim NA, Mahdi BM, Association Between HLA-DRB1 alleles and development of antibodies to infliximab in Iraqi patients with rheumatoid arthritis, Basic Research Journals, 6(3): 30-35, 2017.

3.            Bálint A, Rutka M, Végh Z, et al. Frequency and Characteristics of Infusion Reactions during Biosimilar Infliximab Treatment in Inflammatory Bowel Diseases: results from Central European nationwide cohort, Expert Opinion on Drug Safety, 16(8):885-890, 2017.

4.            Lombardi S, Bernardoni C, Bertolucci D, et al. Biologic therapies in rheumatic diseases: drug and anti-drug antibody levels and clinical efficacy. Journal of Autoimmunity and Cell Responses, 4(1), 2017.

5.            Gregoritza M, Messmann V, Abstiens K, Brandl FP, Göpferich AM, Controlled antibody release from degradable thermoresponsive hydrogels cross-linked by Diels-Alder chemistry, Biomacromolecules, Just Accepted Manuscript, 2017.

6.            Aldrich MB, Velasquez FC, Kwon S, Lymphatic delivery of etanercept via nanotopography improves response to collagen-induced arthritis, et al., Arthritis Research & Therapy 19:116, 2017.

7.            Kolar M, Duricova D, Bortlik M, et al., Infliximab Biosimilar (Remsima TM ) in Therapy of Inflammatory Bowel Diseases Patients: Experience from One Tertiary Inflammatory Bowel Diseases Centre, Digestive Disease, 35:91–100, 2017.

8.            Gibellini L, De Biasi S, Bianchini E, et al. Anti-TNF-α Drugs Differently Affect the TNFα-sTNFR System and Monocyte Subsets in Patients with Psoriasis. Richard Y, ed. PLoS ONE. 11(12), 2016

9.            Julsgaard M, Christensen LA, Gibson PR, Gearry RB, Fallingborg J, Hvas CL,Bibby BM, Uldbjerg N, Connell WR, Rosella O, Grosen A, Brown SJ, Kjeldsen J,Wildt S, Svenningsen L, Sparrow MP, Walsh A, Connor SJ, Radford-Smith G, LawranceIC, Andrews JM, Ellard K, Bell SJ. Concentrations of Adalimumab and Infliximab in Mothers and Newborns, and Effects on Infection. Gastroenterology. Jul;151(1):110-9, 2016.

10.         Jonathan GG, Beatriz AÁ, Nazco C GJ, Norberto BL, Fernando GN. Plasma levels of trastuzumab in gastric cancer: Case report. J Oncol Pharm Pract. Sep 23, 2016.

11.         Choi SY, Kang B, Lee JH, Choe YH. Clinical Use of Measuring Trough Levels and Antibodies against Infliximab in Patients with Pediatric Inflammatory Bowel Disease. Gut Liver,  2016.

12.         Chen L., et al., Efficient Production of a Bioactive Bevacizumab Monoclonal Antibody Using the 2A Self-cleavage Peptide in Transgenic Rice Callus. Frontiers in Plant Science, 7 (1156), 2016.

13.         Farkas K., et al., Efficacy of infliximab biosimilar CT-P13 induction therapy on mucosal healing in ulcerative colitis. Journal of Crohn's and Colitis Advance Access published, 2016.

14.         Gutiérrez A, Zapater P, Juanola O, Sempere L, García M, Laveda R, Martínez A, Scharl M, González-Navajas JM, Such J, Wiest R, Rogler G, Francés R. Gut Bacterial DNA Translocation is an Independent Risk Factor of Flare at Short Term in Patients with Crohn's Disease. Am J Gastroenterol.,111(4):529-40, 2016.

15.         Won Jae Song, Ben Kang, So Yoon Choi, and Yon Ho Choe. Adalimumab Treatment in Pediatric-Onset Crohn’s Disease Patients after Infliximab Failure: A Single Center Study. Pediatr Gastroenterol Hepatol Nutr.; 19(2): 116–122, 2016.

16.         Hayashi S, et al., Early Prognostic Factors Associated with the Efficacy of Infliximab Treatment for Patients with Rheumatoid Arthritis with Inadequate Response to Methotrexate. Rheumatol Ther., 3:155–166, 2016.

17.         Bortlik M., et al., Discontinuation of anti-tumor necrosis factor therapy in inflammatory bowel disease patients: a prospective observation. Scandinavian Journal of Gastroenterology, 51(2), 196–202, 2016.


18.         Kui R, Gál B, Gaál M, Kiss M, Kemény L1, Gyulai R. Presence of antidrug antibodies correlates inversely with the plasma tumor necrosis factor (TNF)-α level and the efficacy of TNF-inhibitor therapy in psoriasis. J Dermatol.,43(9):1018-23, 2016.

19.         Al-Karkhi M.A., et al., Correlation between Anti-infliximab and Anti-CCP Antibodies Development in Patients with Rheumatoid Arthritis Treated with Infliximab in Baghdad Teaching Hospital. IOSR Journal of Dental and Medical Sciences, 14(11) : 95-100, 2015.


20.         Bodini G., Edoardo G. Giannini, Edoardo V. Savarino, and Vincenzo Savarino. Adalimumab Trough Levels and Response to Biological Treatment in Patients With Infl ammatory Bowel Disease: A Useful Cutoff in Clinical Practice. Am J Gastroenterol., Vol.110, 2015.

21.         Juanola O., et al., Anti-TNF-alpha loss of response is associated with a decreased percentage of FoxP3+ T cells and a variant NOD2 genotype in patients with Crohn’s disease. J Gastroenterol,50:758–768, 2015.

22.         Fujita T, Murata Y, Hemmi S, Kajiwara M, Yabuki M, et al. (2015) Persistent Complement Activation is Associated with Insulin Resistance and Chronic Inflammation in Overweight Patients with Type 2 Diabetes with Dyslipidemia. Int J Immunol Immunother 2:007, 2015.

23.         Malíckova K, et al., Serum trough infliximab levels: A comparison of three different immunoassays for the monitoring of CT-P13 (infliximab) treatment in patients with inflammatory bowel disease, Biologicals 2015.

24.         Farkas K. et al, Efficacy of the new infliximab biosimilar CT-P13 induction therapy in Crohn’s disease and ulcerative colitis experiences from a single center. Expert Opin. Biol. Ther. 15:(9) 2015.

25.         Lee Y.M. et al, Infliximab ‘‘Top-Down’’ Strategy is Superior to ‘‘Step-Up’’ in Maintaining Long-Term Remission in the Treatment of Pediatric Crohn Disease. JPGN 60: (737–743), 2015.

26.         Al-Karkhi M.A., et al., Development of Antibodies against Infliximab in Iraqi Patients with Rheumatoid Arthritis. J Fac Med Baghdad, 57: (241-243), 2015

27.         Bergen T.V., et al., Complementary effects of bevacizumab and MMC in the improvement of surgical outcome after glaucoma filtration surgery. Acta Ophthalmologica, 667-678, 2015.

28.         Aydın C, Ataoğlu H., Demonstration of β-1,2 Mannan Structures Expressed on the Cell Wall of Candida albicans Yeast Form But Not on the Hyphal Form by Using Monoclonal Antibodies Mikrobiyol Bul 49(1): 66-76, 2015.


29.         Kozub P, Curkova AK, Zuzulova M, Simaljakova M, Management of Infliximab Treated Patients with Psoriasis Based On Infliximab Plasma Levels and Antibodies to Infliximab, Clinical & Experimental Dermatology Research, 5(2), 2014.

30.         Pallagi-Kunstár É. et al., Utility of serum TNF-a, infliximab trough level, and antibody titers in inflammatory bowel disease. World J Gastroenterol. 20(17): (5031-5035), 2014.

31.         Khanna R., et al., Therapeutic Drug Monitoring of TNF Antagonists in Inflammatory Bowel Disease. Gastroenterology & Hepatology, (478-489),2014.

32.         Krajcovicova A. et al., Delayed hypersensitivity reaction after initial dose of infliximab: a case report. European Journal of Gastroenterology& Hepatology, 26:(485-487), 2014.

33.         Erdemli Ö, et al, In vitro evaluation of effects of sustained anti-TNF release from MPEG-PCL-MPEG and PCL microspheres on human rheumatoid arthritis synoviocytes.2014. Journal of Biomaterials Application, 29(4):524-42, 2014.

34.         Avdeeva A.A., Aleksandrova E.N., Karateev D.E., Luchikhina E.L., Novikov A.A., Cherkasova M.V., Nasonov E.L. Effıcacy Of Adalımumab In Early Rheumatoıd Arthrıtıs In Relatıon To Its Serum Level And The Presence Of Antı-Drug Antıbody, Rheumatology Science and Practice, 52(6):624–630, 2014.

35.         Bortlik M, et al, Impact of Anti-Tumor Necrosis Factor Alpha Antibodies Administered to Pregnant Women With Inflammatory Bowel Disease on Long-term Outcome of Exposed Children. Inflamm Bowel Dis 20 : (495-451), 2014.

36.         Jung Y et al., “Temperature-modulated noncovalent interaction controllable complex for the long-term delivery of etanercept to treat rheumatoid arthritis”, J. Control. Release 2013.

37.         Gutierrez A, et al, Genetic susceptibility to increased bacterial translocation influences the response to biological therapy in patients with Crohn’s disease, Gut 0:1–9, 2013

38.         Grosen A., et al, Infliximab concentrations in the milk of nursing mothers with inflammatory bowel disease, J Crohns Colitis 2013. 

39.         Romero G., et al, Poly(Lactide-co-Glycolide) Nanoparticles, Layer by Layer Engineered for the Sustainable Delivery of AntiTNF-α. Macromol. Biosci. 13: (903–912), 2013.

40.         Cheong C, et al, Etanercept Attenuates Traumatic Brain Injury in Rats by Reducing Brain TNF-α Contents and by Stimulating Newly Formed Neurogenesis, Mediators of Inflammation, 2013; Volume 2013,
Article ID 620837, 9 pages **http://dx.doi.org/10.1155/2013/620837

41.         Bortlik M et al, “Pregnancy and newborn outcome of mothers with inflammatory bowel diseases exposed to anti-TNF-a therapy during pregnancy: three-center study”, Scandinavian Journal of Gastroenterology. 48: 951–958, 2013.

42.         Bodini G, Savarino V, Fazio V, et al. Relationship Between Drug Serum Concentration and Clinical Activity in Patients With Crohn Disease Who Achieved Remission With Adalimumab – a Prospective Study,Aga, Volume 142, Issue 5, Supplement 1, Page S-388, 2012.

43.         Bortlik M, et al, Infliximab trough levelsmay predict sustained response to infliximab in patients with Crohn's disease, Journal of Crohn's and Colitis, 2012.

44.         Malickova K, et al, Phosphatidylserine-dependent anti-prothrombin antibodies (aPS/PT) in infliximab-treated patients with inflammatory bowel diseases, Autoimmun Highlights, 2012.

45.         Takahashi H, et al, Plasma trough levels of adalimumab and infliximab in terms of clinical efficacy during the treatment of psoriasis, Journal of Dermatology, 39: 1- 4, 2012. 

46.         Seok Lee Y, et al, “Efficacy of Early Infliximab Treatment for Pediatric Crohn’s Disease: A Three-year Follow-up”, Pediatric Gastroenterology, Hepatology & Nutrition, 15(4):243-249, 2012.

47.         Molnar T, et al, “Importance of trough levels and antibody titers on the efficacy and safety of Infliximab therapy in inflammatory bowel disease”, Z Gastroenterol, 50 - A53, 2012.

48.         Kato S, et al, “Elevated Serum IgE Prior to Acute Severe Infusion Reaction During Infliximab Maintenance Therapy in a Crohn’s Disease Patient”, Crohn’s & Colitis Foundation of America, 2011.

49.         Adisen E, et al, “Anti-infliximab antibody status and its relation to clinical response in psoriatic patients”: A pilot study, Journal of Dermatology, 37: 708–713, 2010.



POSTER PRESENTATIONS:

1.                   Patil A, Upadhyaya SK, Dawar R, et al., Through Infiliximab Levels and Anti-Infiliximab Antibodies in Spondyloarthritis Patients on Treatment with Low Dose Infiliximab: A Single Centre Cross-Sectional Study, BMJ Journals, Annals of the        Rheumatic Diseases,  (2017).

2.                   Malickova K, Duricova D , Kolar M, et al., No difference in immunogenicity of the original and biosimilar infliximab in patients with inflammatory bowel disease: short-term results, First Medical Faculty and General Teaching Hospital, Charles University, Institute of Medical Biochemistry and Laboratory Diagnostics, Prague, Czech Republic, 2 ISCARE, IBD clinical and research centre, Prague, Czech Republic, (2017).

3.            H. Akbulut, et al: The role of immune system on the efficacy of bevacizumab in patients with metastatic colorectal cancer (mCRC). Medical Oncology, Ankara University School of Medicine, Ankara, Turkey. 1553 P, Annals of Oncology, Volume 27, 2016, 7–11 October 2016, Copenhagen, Denmark.

4.            Perez I, Fernandez L, Sanchez-Ramón S,  P551 Comparison of 4 assay kits for measuring infliximab trough levels and antibodies to infliximab in patients with inflammatory bowel disease,Hospital Clínico San Carlos, IBD Unit, Madrid, Spain, Hospital Clínico San Carlos, Clinical Immunology, IdiSSC, IBD Unit, Gastroenterology,2016 Madrid, Spain.

5.            Goldberg R., et al, Predictors of sub-therapeutic infliximab oradalimumab trough levels and anti-drug antibodies and their influence on therapeutic decisions, ECCO 2014 Inflammatory Bowel Disease.

6.            Julsgaard M., et al, Intra-uterine Exposure to Anti-TNF-alpha therapy(ERA study):Infliximab and adalimumab cord blood levels correlate with maternal levels at birth, ECCO 2014 Inflammatory Bowel Disease.

7.            Szepes Z., et al, Clinical utility of measuring serum TNF alpha level, anti TNF alpha levels and antibody titers in critical situations in inflammatory bowel disease and in psoriasis, ECCO 2014 Inflammatory Bowel Disease.

8.            Julsgaard M, et al, Time since last drug exposure in pregnancy determines Adalimumab and Infliximab levels in neonates(Era Study), Italy 2014.

9.            Bodini G, et al, Correlation between Adalimumab trough serum concentration, Anti-Adalimumab antibodies and TNF-Alpha levels with clinical outcome in patients affected by Crohn’s disease,. United European Gastroenterology. Italy 2013.

10.         Duricova D, et al, Predictors of sustained response to infliximab with Crohn’s disease: A single cohort study, Czech Republic

11.         Lukas M, et al, Anti-infliximab antibodies in routine clinical practice is it worth to assess them, Czech Republic

12.         Malickova K, et al, Relationship between serum trough infliximab levels, serum antibodies to infliximab, serum albumin levels and clinical response to infliximab treatment in patients with inflammatory bowel diseases, Charles University in Prague Czech Republic. (2011)

13.         Malickova K, et al, Formation of antiphospholipid antibodies and antibodies to infliximab in anti-TNF-alpha antibody-treated patients with inflammatory bowel diseases, Charles University in Prague Czech Republic (2011).

14.         Malickova K, et al,. Monitoring patients treated with infliximab: Assessing Anti-Infliximab antibodies, Czech Republic. EUROMEDLAB. Autoimmune diseases 2009. S115




THESIS
1.            PhD Thesis:

La Spectrometrıe De Masse Applıquee A La Quantıfıcatıon Absolue Des Antıcorps Monoclonaux Therapeutıques En Mılıeu Plasmatıque Pour La Realısatıon D’etudes Pharmacocınetıques Pharmacodynamıques

Dr.Rachel LEGERON-LIEUTENANT
Universitè de Bordeaux
     In French           


2.            PhD Thesis:
Evaluation Of Transscleral Permeability Effects Of Nanotechnology Based Drug Delivery System In Ocular Drug Applications
Dr. NAGİHAN UĞURLU
Hacettepe University
In Turkish with English abstract
 
3.            PhD Thesis:
Investigation Of The Pathomechanism Of Diarrhoea-Related Diseases
Dr. ÉVA PALLAGI
University of Szeged
In English
 

PATENTS
1.            Controled drug delivery systems for anti-TNF-α WO 2014046631 A1

 

2.            Preparing method and medical application of optimized plant source recombination humanized bevacizumab
 
3.            Genetically modified micro-organ secreting antibody and methods of use