Phadia AB extends its offer in the field of personalized medicine and tests to detect antibodies against drugs thanks to a partnership with Biomonitor A/S.

“”To join our portfolio BioMonitor iLite technology we become the most complete provider of solutions for antibody against drugs tests”, said Hans Johansson, director of Phadia business development. “Now we can offer services and products relating to the tests to detect antibodies against drugs in a spectrum, from preclinical research to the monitoring of patients in clinic for most of the clinically relevant tests of this kind”.

Immunogenicity and monitoring of patients

A growing concern in the development of medicines bioterapéuticos is the response of the immune system to each drug. Guidelines from the authorities require data on any immunological response and encourage early evidence of immunogenicity for all patients in development. In the case of medicinal products for clinical use, the monitoring of drugs bioterapéuticos constitutes a component of the personalization of medical treatment in a scheme that allows the regular testing of the patient to measure levels of bioactive of medicine and the possible formation of antibodies that Deplete the action of the drug. The patients are expensive, and when administered to treat chronic diseases, it is essential to monitor the reaction of the patient to optimize health care and control diseases associated with the disease.

Phadia AB, leader in diagnosis of Allergy and autoimmunity world for more than 40 years, recently adopted a strategy to commercialize their technologies for measurement of antibody in the field of the detection of antibodies against drugs.

The clinical laboratory of Phadia platform is used in more than 3,000 clinical analysis laboratories in the poses. The current platform can adapt easily to monitor the levels of antibodies to the drug in patients receiving treatment with medications biopharmaceuticals.

Work and investigations of Biomonitor have gained him a place among the world leaders in trials based on cells and the monitoring of patients with treatment of bioterapéuticos due to the use of proprietary tests and other drugs. In the past eight years Biomonitor has actively participated in the Danish multiple sclerosis group and monitored patients who suffer from this disease and are treated with interferon beta. In addition, the company has monitored neutralizing antibodies against the drug and drug levels in patients with rheumatoid arthritis and Crohn’s disease treated with alpha TNF antagonists.

Technology iLite (TM)

The Alliance is based on the technology iLite (TM) of Biomonitor. This patented technology combines a sophisticated methodology for testing of indicator gene cells Cryopreserved and inhibited Division can answer sensitive and reliably to report activity of the drug biotherapeutic in the serum of the patient and can measure levels of neutralizing antibodies. Cells Biomonitor (TM) iLite are manufactured and tested according to the strictest standards of quality (certification ISO 13485) and have been validated in various laboratories.

Dr. Arsalan Kharazmi, CEO of Biomonitor, commented: “we are pleased and excited with Phadia collaboration;” Thanks to her, Biomonitor can take advantage of our years of experience in cell-based analysis and the monitoring of patients, and employ our patented technology comprehensively iLite (TM) of indicator gene with the help of our extraordinary company of diagnosis. “We are convinced that the monitoring of drug bioterapéuticos will increase the efficacy of treatments, will result in savings for health care systems and improve the care provided to patients”.

Hans Johansson, Phadia business development director, said: “In this new and important market, our platform ImmunoCAP provides valuable clinical the clinical professional staff.” Technologies based on cells, such as iLite, are an essential component to accelerate developments in this field. “We are excited you about greatly add iLite technology to offer we provide clinics and pharmaceutical companies in order to improve the achievement of new patients”.

About Biomonitor

Biomonitor A/S is a Danish private company, founded in 2003 and funded by Sunstone Capital, Denmark. Among the leading companies in the development of innovative and reliable for testing technologies, and the incorporation of such analysis to complex and extensive programs of monitoring patients. In addition to the programs of monitoring for patients with multiple sclerosis, the company offers services of clinical analysis for patients in therapy anti-TNF (both levels of medication and detection of antibodies to the drug) and, as a contract research organization, supporting the pharmaceutical and biotechnology industries in their drug development programs for diverse classes of patients. Biomonitor Limited is a subsidiary wholly owned Biomonitor A/S, located in Galway, Ireland, and is a production plant with ISO certification.

About Phadia

Phadia AB develops, manufactures and sells complete systems for analysis of blood in support to clinicians diagnostic and monitoring of people with allergy, asthma and autoimmune conditions. Its mission is to significantly improve the management of allergy, asthma and autoimmune diseases by providing the health-care professionals superior technologies for diagnosis and clinical expertise. Phadia is provider of seven out of every ten laboratory tests to detect allergies in the world, and four of every ten tests of Autoimmunity in European laboratories.