Nordic Bioscience a/s
For more than 15 years, Nordic Bioscience a/s has been committed to the development of diagnostic products for the improved management of patients suffering from bone and cartilage related diseases, such as osteoporosis, osteoarthritis, rheumatoid arthritis, and bone metastasis. They are among the world leaders in the niche field of bone and cartilage diagnostics and have a comprehensive research and development pipeline dedicated to these areas.
Nordic Bioscience a/s markets several FDA approved laboratory kits which are available worldwide. Their products are predominantly used in preclinical and clinical research, but the role of bone and cartilage diagnostics continues to expand clinically as physicians seek to optimize treatment and monitor disease progression for their patients. The pharmaceutical and biotechnology industries have long recognized the value of biochemical markers in their search for new treatments. Such assessment expedites preclinical and clinical drug development times allowing beneficial treatments get to patients sooner. To facilitate this, Nordic Bioscience has developed a range of products which can be utilized from compound discovery through clinical trials and all the way to patient assessment.
Nordic Bioscience a/s is a dynamic and revenue generating Biotech Company. Its main business activities are centered on the sales of diagnostic products, the continued development of novel biochemical markers, drug discovery, and development.
Of its 66 employees, 30 are directly engaged in research and development.
In 2006 Nordic Bioscience a/s also celebrated the opening of its new subsidiary in Beijing, China.They look forward to see what this will bring of new opportunities in this highly potential market place.
Nordic Bioscience a/s is the mother company of:
Nordic Bioscience Diagnostics a/s
Nordic Research Central Laboratory (Beijing)
Nordic Research Central Laboratory (BRL)
Nordic Bioscience Diagnostics a/s
Nordic Bioscience Diagnostics is fully owned by Nordic Bioscience a/s and operates as the commercial division of the organization. It has headquartered in Copenhagen, Denmark. Here it houses all the research facilities, production, sales & marketing department, finance department and QA department.
The company operates with a global network of 40 distributors.
In 2003 the company established a sister company - Nordic Bioscience Diagnostics Inc. - in Atlanta, USA. It started out with one sales person covering the whole area.
Today the US Company employs 4 people and has moved its address to Chesapeak, Virginia. The new office works as the daily administration, sales office and distribution site. It has a FDA registered US storage facility that enables them to ship all orders to our US and Canadian customers directly from this site, rather than from facilities in Denmark and thereby meet the time sensitive demands of our customers.
Nordic Research Central Laboratory (Beijing)
Nordic Research Central Laboratory (Beijing) ltd (NRCL) is the first independent central laboratory in health services in China founded by Nordic Bioscience, which is headquartered in Denmark and has been offering central laboratory services for more than 15 years to pharmaceutical and biotech industry around the world (Europe, America and Asia) in support of multi-centre Phase I-IV clinical studies. The central laboratory in Beijing inherited the quality services from it’s headquarter and is dedicated to offer services globally and locally
in a time and cost effective manner.
Nordic Research Central Laboratory (Beijing) is composed of a team of highly qualified and motivated scientists with international experiences. We have over 1300 sq. meters of laboratory space with state-of-the-art equipments / instruments. Moreover, all the studies are conducted according to our standard operating procedures and the Quality Assurance Unit audits each study on a regular basis to ensure in compliance with international regulations (GCP/GLP). Also, the central laboratory is subject to audits by sponsors and by local and global regulatory agencies
With all the above mentioned, they are able to deliver standardized central laboratory services in the following areas:
Bone and Cartilage Markers:
Very specific and reliable markers for bone and cartilage, which are available in a number of convenient assay formats for measurements of samples from in vitro, animal and clinical studies, are routinely used in the lab.
The assays can be used either clinically for identification of individuals at risk, monitoring therapeutic effects of treatment, selection of the appropriate therapy for individual patients (e.g. drug selection and dosing), and prediction of therapy outcome, or in preclinical research and drug development (in animal models and tissue culture models).
The markers routinely used include:
• Bone Degradation Marker
• CTX-I - culture, animal, human
• DPD - culture, animal, human
• PYD – animal, human
• Bone Formation Marker
• BAP – animal, human
• Osteocalcin – culture, animal, human
• CICP - human
• Cartilage Degradation Marker
• CTX-II – culture, animal, human
• Osteoclast Marker
• TRAP5b – human
• Bone Metastases Marker
• ALPHA CTX – human
• CICP – human
• Bone Metabolism
• PTH – animal, human
• 1,25 Vit D - human
• Calcitonin - human
• OPG – animal, human
• sRANKL – animal, human
Safety Testing: • Routine clinical chemistry panel,
• Lipids panel
• Routine and non-routine hematological panel,
• Urinalysis with microscope
• Routine staining and special staining
• Paraffin block preparation
• Sectioning/frozen sectioning
• Slides preparation
• Pathology report
• Custom assay development
• Custom assay validation
• PK/PD modeling/report
Analytical Capacity/Stability Testing:
• Method development
• Method validation
• Stability trials for formulation development
• Compound (test substance or test article) characterization
• Identification of impurities and degradation products
Full Logistic Services:
• Study and visit specific lab kit supplies
• Study Specific lab manuals
• Bar coded requisition forms
• Training of study site staff for proper sampling and shipping
• Use of Labware LIMS* system to collect and clean data with detailed audit trail
• Standardized reference ranges, flags & alerts.
• Data consistency checks applied during sample accessioning allowing real time data cleaning.
• Status reports and blinded data reports
• Electronic data transfer (Excel, fixed format or customized format)
• Final reports not issued until all inconsistencies are resolved.
*The LIMS is fully FDA CFR Part 11 compliant with full audit trail to keep track of all data changes
• Short/long term sample storage at -20°C or -80°C
• Temperature monitoring alarm
• Computerized tracking system
The services offered have covered the following therapeutic areas:• Osteoporosis
Biochemical Research Laboratory (BRL)
Biochemical Research Laboratory (BRL) is an international highly specialized laboratory offering a complete range of consulting services in the field of biomarkers to the pharmaceutical and biotechnology industry. Headquartered in Denmark, BRL has provided central laboratory services for more than 15 years to the industry around the world (Europe, America and Asia) in support of multi-centre Phase I-IV clinical studies. BRL is dedicated to offer services globally and locally in a time and cost efficient manner.
BRL is composed of a team of highly qualified and motivated scientists with international experiences. The laboratories are quality certified (ISO 9001) and accordingly, all studies and procedures are conducted according to standard operating procedures. An internal Quality Assurance Unit audits each study on a regular basis to ensure compliance with the protocols as well as to international standards and regulations. This ensures global consistency, quality, reliability and valid results from assay to assay. On top of that, the central laboratory is subject to audits by sponsors and by local and global regulatory agencies.
Although BRL works with biomarkers in a variety of disease areas, the most profound and longest experience lies in the area of bone and cartilage.
For more than 15 years BRL has worked with biomarkers that are global front-liners and has thus established a unique know-how within these areas. This is reinforced by the fact that BRL is a subsidary of Nordic Bioscience a/s. It is thus of essential benefit to our partners that, by working with BRL, they obtain an inherited collaboration with the group that on a continuous basis develops and manufactures innovative markers: This gives flexibility and possibilities to work on tailored solutions for your needs. Our partners may thus have access to new, innovative markers that are not available in other settings.