About Us

Matriks Biotek® is a biotechnology company that conducts research on biotechnology, developing products and offering its products at a global scale helping people to lead a better life.

Matriks Biotek® Co., as a biotechnology company founded in 2002 and is celebrating its 15 years in the business. Production oriented company is committed to R&D and innovation of immune based, molecules and tools that will help well being. On the market with biological drug testing SHIKARI® ELISA kits for 9 years since first produced and commercialized in the whole world market. In 36 countries and over 30 pharmaceutical companies have used and/or using our products with confidence. The use of biologics, mainly humanized recombinant monoclonal antibodies, in certain diseases as pharmaceutical drugs elicits the question of effectiveness in each individually treated person. Monitoring drug levels and antibodies plays an emerging role in the management of lack- or loss of response to recombinant and/or humanized antibodies (i.e., to confirm treatment continuation, adjustment to dose, provide a rationale for switching to another agent or to a different class of biological agent).

Major areas of interest are as follows;

Biological drug testing

Biotherapeutics and novel markers for diseases

Inflammation and Immunology

Obesity, type II diabetes and cardiovascular diease

Infectious diseases

Oncology

•   Each kit is optimized for Cmax-Cmin values of the drugs when measuring especially trough levels. Also researchers can also estimate biological levels in human, mouse, rat and monkey serum or plasma samples for pharmacokinetic studies.

•   Quantitative ELISA kits for anti-drug antibodies (immunogenicity) available for infliximab and its biosimilar CT-P13 and adalimumab. Kits include confirmation reagent to eliminate false positives when reporting the results. More kits will be added for this purpose in the near future.

•   Inter and intra assay CV to fulfill requirements for FDA & EMEA.

•   High recovery rates (%97-98),

•   Low sample volumes (10-25 µl) even if you have very small samples such as mouse serum

•   All liquid and stabilized ready to use reagents.

•   Highest quality materialused. Microplates NUNC®, plastic bottles Nalgene® and glass vials Schott®

•   Our kits are in 96 well format and you can run as much as 90 samples from each kit. (best price for each individual test)

•   Time saver: Short incubation times for biologics testing (55-140 min)

•   Minimum expiry date of 1 year and delivery is at room temperature

•   Immediate delivery (1-5 days all over the world)

•   Kits are suitable for biosimilar work.

•   No radioactivity

•   All Shikari® ELISA kits are porduced under ISO 13485 quality system and have CE IVD mark.

* Hunter, one that pursues something with great desire, searching and finding it out.

EXAMPLE CASE: TIMOTHY RICHMOND

Patient: Timothy Richmond

42 years old

Working in an automotive factory for 17 years.

“4 years ago, I visited a gastroenterologist complaining of stomach ache, diarrhea, loss of appetite, loss of weight and fatigue and he asked me to get some tests after the physical examination. I took the tests he asked for. And based on these findings, he diagnosed me with “Crohn Disease” and I started therapy. I took conventional medication that he prescribed for my therapy for 3 years. At first, everything seemed okay. My complaints were gradually relieved. But, for almost a year, the clinical profile of my disease has changed. The developing of fistulas were started.. My physician added the TNF blocker to the therapy protocol. I benefited from it for the first 8 months. After months 9 and 10, while I was taking it once every 8 weeks regularly, on the week 5 after month 9, my complaints began to increase. My physician suspected it and asked me to make a blood test to measure the drug level. It was the first time that a physician asked me for such a test. It seems that these things happen when you take drugs. After taking the drug for a while, my body developed an antibody against the drug and blocked its effect. And there are kits to determine that. The physician may modify the therapy depending on the results of this test. And at the laboratory that he referred me to, the tests performed with the said kits revealed that my body develop antibody against the drug. My physician added another drug to the protocol to support my immune system. It has been a month now. I feel very good. And I know where to go and what to ask if I experience any problems.”

Physician

“Tim is my patient for 4 years. I diagnosed him with Crohn Disease that is an inflammatory bowel disease. I recommended conventional drugs for his therapy. For the first 3 years that I was following him, there was no problem, but when he came visiting me a year ago, his complaints were increased. I also observed the development of fistulas. The first thing that came to my mind was to add an anti-TNF blocker to the therapy protocol. We started the drug. The therapy was a success for 8 months. However, from months 9 and 10, the complaints of the patient began to increase again. I thought that his body might have developed antibody against the biological drug and asked him to take a test. The only way to find this out was to determine the antibody presence with an ELISA kit. I know a laboratory that I trust very much in these types of cases. I trust them both in terms of personnel and the kits they use. They work with Shikari® ELISA Kits from the beginning. And I never saw them go wrong. I am a physician who believes in the customization of the therapies. It is true that people differ from each other genetically and biologically. And therefore, it is natural for different diseases to have a different course in different people. Why should the therapy be the same then? It should be customized to the individual. I always discuss this in detail with each and every patient that I start to treat. If there are ups and downs during the therapy, i.e. if they do not improve even though they take drugs or they worsen after a while, they inform me. I even have patients that ask for tests with ELISA kit without me recommending it if there is something wrong.”

Laboratory official

“We can’t say that there are a great number of physicians who refer their patients to our laboratory to test the antibody development against the drugs they use. But, as a matter of fact, this rationalist way is becoming a more frequent method gradually. And the reason is the patients themselves. If the patient knows that there is such a method, he warns his physician. If it is an adept and principle physician, there is no need to do that; but the knowledge and the awareness of the patient here is what determines it. We work with Shikari® ELISA Kits from the beginning. Because, the results of the tests performed with these kits comply very well with the clinic of the patient.”

* The names mentioned in this story are fictious and do not reflect real persons.

Matriks Biotek® offers to develop custom ELISA kits for your biosimilars or biologics on contract manufacturing basis depending on the molecule provided. Several projects are ongoing at company for pharmaceutical companies. All projects are kept strictly confidential. If requested with our CRO and GLP laboratory collaborators we also offer Phase 1 studies for your candidate drug.

Similar but not identical

A biosimilar is highly similar to, but not exactly the same as the existing, FDA-approved biologic, called the “reference” drug . People are familiar with generic versions of brand-name drugs, but biosimilars are not generic drugs. Generic versions of brand-name drugs are exact copies of chemically synthesized medicines. Biosimilars are not-quite-perfect copies of biologics – drugs derived from living cells that are impossible to replicate exactly.

Development of biosimilar proteins will present drug developers with a variety of challenges, both in manufacturing and in the clinic. Immunogenicity will prove to be one of the biggest challenges. Proper design and validation of an assay to detect anti-drug antibodies and accurate interpretation of sample analysis results will prove integral to developing a biosimilar protein.

Taking the above and below-mentioned into account Matriks Biotek® produced SHIKARI® Q-REMS and S-AIR as the first ELISA kits for the biosimilar of Infliximab, CT-P13 (Remsima®)and now also offers to develop custom ELISA kits for your biosimilars or biologics on contract manufacturing basis depending on the molecule provided. Matriks Biotek® is the first company to commercialize SHIKARI® ELISA kits for biological drug testing to measure trough levels and anti drug antibodies (immunogenicity) since 2008.

Comparisons for measuring especially ADA and trough levels are made by the tests developed for reference drug not for biosimilar which may differ on the test results. On the contrary we do not know the results when comparisons done by the ELISA kit developed for the biosimilar drug, it can present low immunogenicity as well.

The immunogenicity caused by the production of anti-drug antibodies (ADA) is also an important factor, and in many cases, an effect that prompts discontinuation of treatment. After long periods of treatment, ADA have been detected by the immunoenzymatic essay (ELISA). ADA may cause neutralization of the molecule, affecting PD and PK, making the treatment ineffective.

The causes of immunogenicity can be chimeric biological drugs (e.g. infliximab), even humanized molecules (e.g. adalimumab) and fully humanized biological drugs (golimumab)—most the cases the residual immunogenicity resides in the CDR regions —glycosylation profiles, fermentation, purification, formulation (aggregate formation), administration mode (i.m., i.v. and s.c.), dosing, degradation products and contaminants.

The pharmaceutical formulation strategy is a critical step and needs to be accurate. The knowledge about physical and biological properties of the biological drug orientate the formulation process. Important components of protein formulations are pH, stabilizer, solubilizer, buffer, and tonicity modifier (bulking agent). The typical stability problems observed in protein pharmaceuticals are non-covalent aggregation, covalent aggregation, deamidation, cyclic imide, and cleavages. This process can affect directly the efficacy (e.g. immunogenicity) and safety (e.g. adverse events) of a biological drug.

The potential immunogenicity of a therapeutic protein can be influenced not only by the manufacturing processes mentioned above, but also by the type of disease, route of administration and dose. Biosimilar proteins will most likely not be identical to the innovator drug, and because of this, immunogenicity becomes a major concern when developing biosimilar proteins. The potential exists for serious clinical consequences due to anti-drug immune responses with all protein therapeutics. A safe immunogenicity profile of the innovator product does not indicate that the biosimilar protein will be safe.

Proper immunogenicity assessment of biosimilars requires an in-depth understanding of the design of assays to detect anti-drug antibodies, implementation of proper validation procedures, and experience in analysis and interpretation of sample results. Use of an inappropriate anti-drug antibody assay format, improper validation testing or analysis of sample results may lead to misinterpretation of safety data. Anti-drug antibody assays must be properly designed and developed if they are to perform as intended. Many platforms and assay formats are available, and, depending on the protein therapeutic and its target, not all are appropriate for use. There are many variables that must be considered when developing an assay to detect anti-drug antibodies. The design of the clinical trial (single vs. multiple dose study), anticipated therapeutic drug levels in the immunogenicity samples, therapeutic target of the drug, mechanism of action of drug, and patient disease state all need to be considered when developing immunogenicity assays. Once the appropriate assay has been developed, the assay must be properly validated. Validation must include statistical determinations of both screening and confirmatory cut points. The use of arbitrarily set cut points to determine sample reactivity is improper and scientifically invalid. In order to ensure that the assay performs as expected when analyzing study samples, validation testing must also include assessment of signal precision, from which the in-study acceptance criteria can be generated. During sample analysis, data must be properly analyzed to ensure that the assay is performing as intended and that samples are not being reported as false negatives.

MATRIKS BIOTECHNOLOGY CO., LTD

Gazi Üniversitesi Gölbaşı Yerleşkesi Teknoplaza Binası,
(B Blok Zemin Kat BZ17),
06830,
Gölbaşı/ANKARA/TÜRKİYE

Contact Details

Telephone: +90 (312) 485 42 94
Email: info@matriksbiotek.com
Fax: +90 (312) 485 11 87