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Clinical Diagnostics OEM and Contract Services
Some of the world’s largest suppliers of in vitro diagnostic (IVD) products rely on us as their OEM and contract manufacturing partner. With over 35 years of experience, customers count on us for quality, compliance, and reliability.
We specialize in:
- In vitro diagnostic (IVD) assays and reagents
- Calibrators and multi-constituent QA control materials, including molecular controls
- Clinical chemistry reagent kits
- Coagulation reagent kits and controls
- Particle technologies
- Clinical chemistry and immunoassay instrumentation
- High-throughput lab automation
We also have expertise in identifying and developing novel biomarker assays that serve unmet clinical needs and in developing niche diagnostics assays including, but not limited to, drugs of abuse testing (DAT), therapeutic drug monitoring (TDM), immunosuppressant drug monitoring (ISD), and companion diagnostic tests.
We have a global manufacturing footprint with multiple centers of manufacturing and development excellence. All current contract manufacturing facilities are compliant with FDA, international, and ISO guidelines.
Video: Enabling partner innovation and productivity through custom solutions for the In vitro diagnostics (IVD) market.
Explore our OEM and contract manufacturing services
We have a wide range of capabilities, including large volume liquid formulation and filling, lyophilization, biomarker assay development, antibody production, development and validation of drugs of abuse tests, therapeutic drug monitoring assays, clinical chemistry reagents, calibrators and controls, as well as designing and developing clinical chemistry, immunoassay, and lab automation instrumentation.
Liquid formulation
- Tank capacities
- 400,000 liters of daily formulation capacity
- Batch sizes from 500 liters to 40,000 liters
- Jacketed tanks/stainless steel/non-metal reactive
- Large/small volume filling
- 12 individual fill lines
- Semi-automated to fully-automated high-speed lines
- Less than 1 ml fill to 20 liter; larger volumes easily achieved
- Tubes, vials, bottles, cubitainers, barrels, totes
- Glass and plastic
- Standard and custom containers
Lyophilization, reagent cassettes, kit packaging
Logistics—supply chain management and optimization
- Warehousing and shipping expertise
Our global manufacturing footprint has multiple centers of excellence for development and manufacturing. All current sites are compliant with FDA and international regulations and have ISO 13485 certification.
Centers of excellence
Middletown, Virginia—contract manufacturing and clinical chemistry reagents
- 30,200 square meters (325,000 ft²) of manufacturing, administration, and distribution
- 2,300 square meters (25,000 ft²) of refrigerator and freezer capacity
- 12 environmentally controlled formulation and filling rooms
- ISO Class V to ISO Class VIII
- Two reverse osmosis systems delivering up to 379 liters per minute (100 gal/min) for reagent production
Fremont, California—specialty diagnostics products
- Brand-new multi-million dollar center of excellence
- 25,000 square meters (269,000 ft²) consolidating three existing sites into one
- Improved process flow and logistics
Hennigsdorf, Germany and Nimes, France—novel biomarkers
- Research and development, medical affairs, production, marketing, and sales
- 12,000 square meters (129,000 ft²) in Hennigsdorf
- 2,700 square meters (29,000 ft²) in Nimes
- Manufacturing and QC areas are hygienically controlled and in accordance with the radiation hygiene requirements
- Distribution of nitrogen for freeze-drying facilities and CO² for incubators
Vantaa and Joensuu, Finland—instrumentation and automation
- 7,350 square meters (79,000 ft²) of research and development, manufacturing, and administration
- Focusing on clinical and specialty chemistry instrumentation
- Assembly and testing of desktop instruments, chemistry analyzers, and automation modules
- Reagent formulation and kit fill/label/pack for clinical and industrial diagnostics and qPCR-based tests
- High-volume 24/7 injection molding and pipette assembly
- ISO 9001, ISO 13485:2003, ISO 14001 and CE, CSA/UL, and FDA compliant
China and Eastern Europe—expansions on-going to provide diagnostic reagent manufacture
Our Regulatory and Quality Systems are a cornerstone for our contract manufacturing services. We understand that our customers come to us and stay with us due to the strength and robustness of these systems and processes.
Certifications
- ISO 13485 certified
- ISO 9001 certified
- ISO 14001 certified
- Canadian medical device regulations
- 98/79 EC in-vitro diagnostic directive
- FDA medical device / IVD regulations
Regulatory services
- Experienced with global regulatory agencies and filings
Final product and release testing
- Conducted on customer instrument platforms
- Established analytical instrumentation to allow product performance testing
- Value assignment of calibrators and controls (IFCC/NGSP/nested testing experience)
- Stability monitoring program with software management and trending
Validated assay applications for various diagnostics instrument platforms
We are proud to be able to offer our capabilities to fulfill Thermo Fisher Scientific's mission: to enable our customers to make the world healthier, cleaner and safer.
We offer:
- Large company quality, delivery, and reliability with small company values, responsiveness and flexibility
- Dedicated to OEM and contract manufacturing with industry-leading capabilities
- Experienced manufacturing facilities with benchmark quality system
- Turnkey product solutions from contract development through packaging with all support services available
- Established global manufacturing footprint and infrastructure
- Known and trusted contract manufacturing partner
For more information about our clinical diagnostics services, contact us via phone or email.
Middletown, Virginia
8365 Valley Pike
Middletown, VA 22645
Phone: +1 800-528-0494
Email: sales.diagnostics.mtn@thermofisher.com
Fremont, California
46500 Kato Road
Fremont, CA 94538
Phone: +1 800-232-3342
Email: sales.diagnostics.fmt@thermofisher.com
Hennigsdorf, Germany
Neuendorfstraße 25
16761 Hennigsdorf
Germany
Phone: +49 (0)3302 883 753
Email: info.nebud.brahms@thermofisher.com
Vantaa, Finland
Ratastie 2, 01620
Vantaa, Finland
Phone: +358 10 329 200
Email: sales.cdx.fi@thermofisher.com
