Biomonitor A/S

Leader in Biopharma CRO and patient monitoring services for biotherapeutics

Biomonitor A/S

Biomonitor A/S was founded in 2003. The company has approximately 20 employees located at the CRL in Copenhagen, Denmark, reporter gene based bioassay iLite kits production in Galway, Ireland and a small research setup in Paris, France. The scientific and technical team at Biomonitor has over 20 years of experience in assay development particularly cell-based assays and the use of these assays in determination of the activity and immunogenicity of biopharmaceuticals with focus on patient monitoring.

The company has a “state-of-the art” clinical reference laboratory with modern equipments and facilities. The CRL provides specialized CRO services including PK, PD and Immunogenicity testing under GLP and GCP compliant conditions for biopharmaceuticals under development by pharma and biotech companies. These services have been and are being provided for pharma/biotech companies in USA, Europe, Japan, and the rest of the world.

The company has developed specialized assays based on the company’s iLite TM reporter gene technology to measure drug levels as well as antibodies to these drugs. They assays are used to monitor patients suffering from diseases such as multiple sclerosis, rheumatoid arthritis, and Crohn’s disease for antibodies against the biopharmaceuticals they are being treated with. They are also used to support pharma and biotech companies with immunogenicity testing of new biopharmaceutical drugs. The company is also capable of developing assays including innovative and proprietary cellbased bioassays for its customers.

Biomonitor A/SBiopharmaceuticals are a new generation of highly effective drugs. The major problems with these drugs are that their bioavailabilty varies considerably from patient to patient and that many patients develop antibodies that neutralize the drugs. Biomonitor has developed specialized bioassays to measure drug levels as well as antibodies to these drugs. These assays are being used to monitor patients suffering from diseases such as multiple sclerosis and rheumatoid arthritis for antibodies against the biopharmaceuticals they are being treated with. They are also being used to support pharma/biotech companies with immunogenicity testings of new as well as the existing biopharmaceutical drugs. Testing for antibodies will have a great impact on the proper use of these drugs as well as on reduction in therapy cost incurred by the patients, insurance companies and public institutions.

Biomonitor with its proprietary technologies and assays has reached the advanced stage, where regulatory authorities such as FDA and EMA as well as clinicians treating the patients with biopharmaceuticals have recognized the problem of drug immunogenicity as an essential element to investigate when treating patients with therapeutic proteins and peptides.

Biomonitor is the first-mover in this field, and provides services for patient monitoring as well as pharma/biotech industry developing biopharmaceutical drugs.

Business focus
The primary business focus of Biomonitor is to offer precise and validated bioassays to the developers of biopharmaceuticals for the design and clinical evaluation of drug candidates that target a specific disease, or predict individual patients’ response during drug discovery and development. Biomonitor also enables physicians to identify and define proper therapy while carefully monitoring their patient during treatment.

Our theranostics product and service offerings are:
• R&D Support; Supporting research as well as clinical development of biopharmaceuticals
• Patient Monitoring; Supporting physicians in optimizing treatment regime execution and follow-up of biopharmaceuticals

Biomonitor’s current business focus is the very large market segments of the biopharmaceuticals under development such as cytokines, growth factors, monoclonal antibodies (MAbs), and other therapeutic proteins for the indication areas such as reumatoid arthritis, multiple sclerosis, psoriasis, infections, allergies, cancer and cancer related conditions, diabetes and related conditions.

Core Competency
Biomonitor has a world leadership position due to its focused R&D effort in improving monitoring of biopharmaceuticals. Our theranostics services are used in the drug discovery phase as support during pre-clinical trials, while in the drug development phase during clinical trials as support on individual toxicity testing and drug efficacy studies. In later phases biotech and biopharmaceutical companies perform clinical trials to reveal new disease management indication or differentiate current indications through new documentation of effect. We assists in this process as well as when the focus for production is to ensure appropriate API and formulation qualities. Patient Monitoring Services are typically in the hands of the public healthcare sector and focus for us here is to ensure an appropriate individualized treatment regime.

Biomonitor A/SThe products are based upon the “gene reporter” technology which allows the precise measurement and/or sensitive detection of cytokine bioactivity in complex biological fluids in an easy, simple and rapid test format.

The manufacturing site in Ireland has been certified as meeting the requirements of ISO 13485:2003 for the design and manufacture of cell based assays for the detection of proteins.

The products can be used by both the physician and research investigator in studies to gain a more thorough understanding of certain disease states and also to allow for the optimization of individual patient therapy.

Uses of iLite™ cell-based assays

Bioactivity measurement
iLite™ IFN alphabeta is a simple and rapid test for the detection and quantification of the biological activity of Type I human IFNs.

Immunogenicity testing
iLiteTM technology has been adapted to detect and quantify neutralizing antibodies (NAbs) to IFN alpha, IFN beta and TNF alpha in a robust, reliable and easy to use format using the following kits/cells.
iLite™ IFN antibeta
iLite™ IFN antialpha
iLite™ anti-human IFN-beta-1a
iLite™ anti-human IFN-beta-1b
iLite™ TNF alpha cells
Application of iLite™ cell-based assays
• Pre-Clinical and Clinical Studies
• Clinical Research
• Monitoring Production Yields
• Product Recovery
• Product Purification
• Patient Monitoring (IVD products)

Summary: Biomonitor has a modern Clinical Reference Laboratory with state-of-the-art facilities.

We are specialized in:
• R&D Support; assisting pharma & biotech companies in their protein drug development programs by providing GLP-compliant assays for clinical trials
• Patient Monitoring; assisting physicians in monitoring patients under treatment with biopharmaceuticals

Biomonitor A/S
+45 39 17 97 97
+45 39 20 97 92
http://www.biomonitor.dk