Biomonitor

ARUP Laboratories and Biomonitor A/S Form Partnership

christian — Tue, 10 Aug 2010 15:44:49 +0000

ARUP Laboratories (Salt Lake City, USA) and Biomonitor A/S (Copenhagen, Denmark) Form Partnership in Personalized Medicine to Monitor Multiple Sclerosis Patients in the USA for Neutralizing Antibodies to IFN-beta Using Biomonitor’s iLite^TM Reporter Gene Technology.

Click here for further details

Biomonitor A/S achieves GLP-authorization

christian — Wed, 07 Jul 2010 13:46:51 +0000

We are pleased to announce that as of July 2010, the Danish Medicines Agency has granted Biomonitor A/S a GLP-authorization.

For further information please contact:
Arsalan Kharazmi, CEO, Biomonitor A/S.
E-mail: ak @ biomon.dk, Phone: +45 39179797

Biomonitor announces new products in the iLite™ product range

christian — Wed, 07 Jul 2010 13:42:49 +0000

Biomonitor is proud to present the first IVD cell-based assay kits for NAb detection

iLite^TM anti-human IFN-beta-1a - used for the detection of Neutralizing antibodies against IFN-beta-1a

and

iLite^TM anti-human IFN-beta-1b - used for the detection of Neutralizing antibodies against IFN-beta-1b

Prolonged therapies with many biopharmaceuticals, including IFN-alpha and IFN-beta, often lead to development of neutralizing antibodies (NAb).

The development of these NAbs is a problem which if not recognized may jeopardize therapeutic efficacy of the IFN treatment and cause side effects from local and/or circulating immune complexes.

Treatment with the above mentioned IFN biopharmaceuticals is costly. Monitoring patients for antibody development is therefore both rational and cost-effective.

The application of these rapid and robust cell-based assays include
Clinical Research for Immunogenicity testing Patient monitoring

Click here for details

Biomonitor A/S achieves GMO classification

christian — Wed, 07 Jul 2010 13:36:29 +0000

We are pleased to announce that as of June 2010, the laboratories of Biomonitor A/S have been classified for working with genetically modified organisms (GMO).

For further information please contact:
Arsalan Kharazmi, CEO, Biomonitor A/S.
E-mail: ak @ biomon.dk, Phone: +45 39179797

Biomonitor A/S completes Round C private placement

christian — Wed, 07 Jul 2010 13:24:09 +0000

We are pleased to announce that as of March 2010, Biomonitor A/S has completed Round C private placement with the Danish venture capital company Sunstone Capital A/S.

For further information please contact:
Arsalan Kharazmi, CEO, Biomonitor A/S. E-mail: ak @ biomon.dk, Phone: +45 39179797
Søren Lemonius, Partner, Sunstone Capital A/S, E-mail: Lemonius @ sunstonecapital.com, Phone: +45 40814889

Biomonitor acquires the Irish company Neutekbio

arsalan — Wed, 03 Dec 2008 15:06:37 +0000

Please download the press release for further details.

We are pleased to announce that Biomonitor has acquired Neutekbio Ltd. on 27. November 2008. Neutekbio has a proprietary platform of products based on reporter gene technology and developed cell-based assays and kits called iLite™ , which complement Biomonitor’s offerings in assays for patient monitoring and biopharmaceutical drug development programs.

For further information please contact:
Arsalan Kharazmi, CEO, Biomonitor A/S. E-mail: ak @ biomon.dk, Phone: +45 39179797
Søren Lemonius, Partner, Sunstone Capital A/S, E-mail: Lemonius @ sunstonecapital.com, Phone: +45 40814889

Sunstone Capital invests in Biomonitor A/S

mark — Thu, 03 Jul 2008 12:44:26 +0000

We are pleased to announce that the Danish venture capital company Sunstone Capital A/S has invested in our company. Biomonitor A/S is with this investment ready to go after the $ 800M theranostics market for screening for antibodies against biopharmaceuticals.

Please download the press release for details.

Guidelines On The Clinical Investigation of the Pharmacokinetics of Therapeutic Proteins come into effect

mark — Tue, 31 Jul 2007 09:34:43 +0000

Biomonitor’s work within immunogenicity of therapeutic proteins has been recognized by the European Medicines Agency (EMEA)

EMEA have formulated a set of “Guidelines On The Clinical Investigation of the Pharmacokinetics of Therapeutic Proteins” that came into effect on 31. july 2007.

An abstract of the guidelines on immunogenicity is provided below and full document is available for download.

Immunogenicity of therapeutic proteins now recognized by EMEA

arsalan — Fri, 06 Jul 2007 09:47:18 +0000

In a draft publication, Guidelines on the Clinical Investigation of the Pharmacokinetics of Therapeutic Proteins, the European Medicines Agency (EMEA) now recognizes Immunogenicity as an essential element to investigate when treating patients with therapeutic proteins and peptides.

Paper published on individualized monitoring of drug bioavailability and immunogenicity in rheumatoid arthritis patients treated with the tumor necrosis factor alpha inhibitor Infliximab

mark — Wed, 15 Nov 2006 12:07:44 +0000

In a paper published in Arthritis and Rheumatism, Bendtzen & coworkers used Biomonitor’s RIA’s for infliximab/Remicade® and anti-infliximab Ab to monitor RA patients. They demonstrated the high frequency of patients with Ab, and they showed that development of antibodies, heralded by low pre-infusion serum-infliximab levels, is associated with increased risk of infusion reactions and treatment failure. They conclude that early monitoring helps optimize dose regimens to individual patients, diminishes side-effects and prevents prolonged use of inadequate infliximab therapy.

Download the paper here