Complete Solutions for IVD ELISA Manufacturers – From Raw Materials to Risk Mitigation

Your Partner from Concept to Clinic

Simplify ELISA assay development and manufacture with a partner who understands the IVD market

Accelerate your time to market with our fit-for-use products which offer the quality, consistency and documentation necessary for every step of your IVD development and manufacturing process.

Proven expertise in ELISA assay development

ELISA assay developmentLeverage our extensive ELISA (enzyme-linked immunosorbent assay) development knowledge, based on in-depth product development and manufacturing experience, and supported by IVD industry partnerships.

Discover the value of partnering from concept to clinic

Partner with us early in development to source raw materials aligned with your needs, ensuring a smooth and efficient transfer from R&D through to commercialization.

We offer:

  • Product selection assistance
  • Risk mitigation support
  • Clear quality and supply chain guidelines
  • A reliable and transparent global supply chain
  • Proactive forecasting
  • Superior documentation
  • Regulatory insight

Impact of early supplier involvement
Supplier impact on investment

Diagnostic Elite: Critical raw materials for mitigating risk in IVD manufacturing

The Diagnostic Elite program was developed as an enhanced portfolio of raw materials with your IVD manufacturing needs in mind. Every Diagnostic Elite raw material is designed to promote consistency across your entire product process, with the goal of improving manufacturing effectiveness while minimizing your level of risk.

The Diagnostic Elite program leverages our knowledge of IVD industry regulations, manufacturing, quality and supply chain management to provide you with the required level of support to meet your IVD manufacturing requirements.

Elite quality gradeAlign quality to criticality

Raw materials of higher criticality have increased quality expectations.

The Elite quality grade has the advantage of offering nearly all GMP quality attributes without the associated cost burden. IVD market feedback indicates that the Elite grade is a good fit for critical raw material usage, balancing the need for consistency, transparency and control, against price.

Our Enhanced Quality Guidelines outline the different levels of quality, documentation and supply chain traceability that we can provide to diagnostic manufacturers.

Bulk and custom raw materials & contract (OEM) manufacturing for ELISA assay developers

We offer years of experience in critical and non-critical raw material manufacturing, supporting a full range of custom and contract manufacturing services for diagnostic manufacturers.

Scale-up from concept to manufacturingLet us partner with you from the development of the initial concept, through to scale up and final manufacturing. We ensure that you have quality products, at the optimal scale, at the right time, to aid your rapid commercialization.

The flexibility to meet all of your manufacturing needs:

  • Bulk configured reagents
  • Customized packaging and labeling
  • Custom reagent formulation
  • Custom QC and assay support

Contract (OEM) manufacturing of finished IVD ELISA kits

Finished IVD ELISA kitsIn addition to providing chemical and biological raw materials to ELISA assay developers and manufacturers, we also have an extensive business of contract manufacturing IVD products, including ELISA and other immunoassays, under our customers’ labels at our ISO 13485- and FDA-registered facilities.

Whether you are bringing a new product to market or looking to outsource an existing product, you can achieve seamless vertical integration with a raw material and finished goods production partner who has over 350 years of life science manufacturing experience.

  • ISO 13485- and FDA-registered production sites
  • Dedicated project support
  • Extensive manufacturing expertise
  • Functional QC run on your instruments

Meeting your complete raw material needs for ELISA IVD assay manufacturing

Meeting your complete raw material needs

ELISA Assay Products

Antibody Portfolio and Custom Services – Take advantage of a broad product offering, supported by the expertise and customization you require

Reagents for Antibody and Protein Production – Helping you manufacture the assay components you need

Detection Enzymes, Substrates and Coupling Reagents – Enabling your chosen detection method

Estapor® Magnetic and Polymeric Microspheres – Benefit from a consistent, sensitive and flexible range of assay enhancing options

Discover the possibilities in assay automation and purification through:

Blocking Agents – Secure the quality reagents you require for your assay's performance

One-Stop Shop for Ancillary Reagents – Simplicity and convenience to accelerate your commercialization

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