Our Core Custom Services
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Protein Production
Protein Production
Develop custom proteins with our expertise in cloning, purification, expression, conjugation, formulation, and modification to fulfill your early phase experimental and long-term supply chain needs.
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Antibody Services
Antibody Services
Our custom antibody services range from recombinant conversion to immunization and purification, as well as engineering for cell therapy applications.
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Luminex® Assay Development
Luminex® Assay Development
Develop custom Luminex assays by using our extensive inventory of antibody panels and protein antigens to develop a multiplex panel for biomarker screening, and IVD or LDT assay development.
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ELISA Kit Services
ELISA Kit Services
Create custom ELISA kits with assays optimized specifically to your research, toxicology, pre-clinical, or direct clinical goals by partnering with our scientists who developed our Quantikine® ELISA kits.
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Professional Assay Services
Professional Assay Services
Advanced Cell Diagnostics, a Bio-Techne brand offers Professional Assay Services (PAS), enabling direct access to RNAscope™ in situ hybridization (ISH) technology. Accelerate your journey in target validation, preclinical, and clinical development with the promise that we will provide consistent and trustworthy data to drive your projects forward.
Other Custom Services...
We Support Your Diagnostic and Therapeutic Breakthroughs
Our Custom Manufacturing Services are Your Partner from Discovery to Compliance and Beyond
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The Bio-Techne Advantage
When you initiate your custom antibody, protein or ELISA Assay project through Bio-Techne's custom services program, you not only receive an outstanding product, but you also join the R&D Systems' family. Our scientists, researchers, support staff, and experts are here to make sure you receive what you need, when you need it, to get you results faster.
ISO-certified
ISO-certified
Our products are manufactured under compliance with ISO-9001 and/or ISO-13485 certifications. For more information see our Certifications page.
FDA Registered
FDA Registered
Bio-Techne is an FDA registered Medical Device Establishment and is routinely inspected.
GMP Conversion
GMP Conversion
Confidently rely on us to convert your RUO product into a GMP qualified product. For more information see our GMP Quality Support page.
Dedicated Project Managers
Dedicated Project Managers
Our products are manufactured under compliance with ISO-9001 and/or ISO-13485 certifications. For more information see our Certifications page.
Scientific Expertise
Scientific Expertise
Bio-Techne is an FDA registered Medical Device Establishment and is routinely inspected.
Long-Term Supply
Long-Term Supply
Confidently rely on us to convert your RUO product into a GMP qualified product. For more information see our GMP Quality Support page.
Our Development Cycle
Our development cycle starts with you. Are you facing difficult research challenges? Is it difficult to source the media or materials you need? We are here to help.
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Bio-Techne Quality
All of our custom production and contract services are governed by established, thorough quality assurance measures, so you can have the utmost confidence in your data accuracy and the performance of your custom products. Bio-Techne's FDA-regulated facility allows you to move seamlessly into regulatory agency submissions alongside our regulatory affairs team as your partner. Most importantly, our compliant manufacturing facilities ensure that, following the success of your initial experimental research, we can provide large-scale amounts of critical, specialist reagents to ensure your continued successes. Our policies conform with the requirements of:
- Quality System Regulations for Medical Devices, ISO 13485:2003 and ISO 9001:2008 Standard
- (The) Code of Federal Regulations (21 CFR 820)
- (The) Canadian Medical Device Regulations
- (The) In Vitro Diagnostic Directive 98/79/ EC
Luminex® is a Registered Trademark of Luminex Corporation.