March 01, 2021

Custom services to accelerate diagnostic assay development

By Cytiva Diagnostic Services

Take advantage of our resources and expertise to accelerate the development of your molecular and immunodiagnostic assays.


Advances in point-of-care, molecular and immunodiagnostic assay development are enabling a personalized, high-precision approach to health in many clinical areas. Researchers are discovering new genetic factors for diseases, such as SARS-CoV-2, Alzheimer’s and cancer in rapid succession. Diagnostic tests that help identify biomarkers and individuals genetic characteristics guide healthcare professionals to not only predict and prevent disease, but to provide effective, biologically targeted, therapeutic interventions.

Cytiva Diagnostic Services helps you accelerate diagnostic assay development, from early-stage concept and prototype to manufacturing and commercialization. Our laboratory infrastructure, technical expertise and consultation services can help you get to market faster. Here we talk about the genomics services offered at our center of excellence in Cardiff, UK.

Many of our Amersham and Sera-Mag products are used as tools and/or components in applications in life sciences, diagnostics, pharmaceuticals, and environmental sciences. Building on this established portfolio, our Cytiva Diagnostic Services team offers a custom solutions and contract manufacturing to supplement your day-to-day operations, increase your profitability, and simplify your existing workflows. Our services include lyophilization, conjugation, contract manufacturing, custom biology and custom plates.

Lyophilization services

Lyophilization, also called freeze drying and cryodesiccation, is the process of removing water from a substance at low temperature. Our Lyo-Stable stabilization technology maximizes product or sample stability and shelf life, maintains chemical or biological function, and enables easier and more sustainable transportation and storage compared to a cold chain.

Stabilization by lyophilization enables the production of pre-dispensed, single-dose reagents, which help:

  • simplify assay setup
  • increase assay robustness and reliability
  • reduce the risk of sample contamination

 

Our patented lyophilization technology can be applied to stabilize individual proteins and reagents, as well as complete multiplex assays, by providing a molecular environment that protects against conformational changes in protein structure. From simple buffers to multi-component kits, our Lyo-Stable custom stabilization team can develop and manufacture custom products in small or large batch sizes to meet your requirements

Custom conjugation services

There are many types of superparamagnetic beads available. Different surface coatings and chemistries give each type of bead its own binding properties, which can be used for magnetic separation (isolation and purification) of nucleic acids, proteins, or other biomolecules in an easy, effective, and scalable way.

Even with all these surface chemistry options, it’s impossible to cover every need and eventuality. That’s where custom conjugation comes in. We optimize reagents and magnetic beads for your application using concentration, reformulation, binding and adaption of particle sizes and functionalities. This service is possible for any of our protein and nucleic acid sample preparation, labeling and detection products, including Sera-Mag magnetic beads (Sera-Mag Carboxyl, Streptavidin, Blocked-Streptavidin, Oligo dT and Neutravidin).

We provide custom conjugations of enzymes or antibodies, as well as a range of custom ligands and particle sizes that we can develop in parallel with your projects. Drawing on our R&D and manufacturing resources, and experience in supplying magnetic beads, we will provide custom magnetic bead technology that is ready to use with little or no need for further modification. From completing complex conjugations, to performing your quality control tests before the beads leave our factory, we are equipped to meet your needs.

Contract manufacturing

With facilities capable of accommodating manufacture of simple buffers through to multi-component kits for both low and high throughput customers, we can comfortably manufacture your specific product(s) for use in pharmaceuticals, diagnostic applications, and life science research.

Our reagent and kit manufacturing allows you to take advantage of our team’s extensive knowledge and experience in sourcing and validating raw materials, and our ISO certified manufacturing facilities. A dedicated team will guide you through the process of developing your minimum viable product to a commercial product from the initial proof of concept through to batch validation and into production. Our methodology and processes are designed with the aim of ultimately creating a seamless transition to large scale manufacturing to meet the desired quality standards.

Custom biology services

When our standard off-the-shelf products do not meet your specific application requirements, our Cytiva Diagnostic Services team can tailor the configurations, formulations, pack sizes and concentrations to your needs. Our processes ensure the same quality, performance and reliability as our standard products with lot-to-lot consistency assured. Custom biology services are possible for any of our protein and nucleic acid sample preparation, labeling and detection kits. Just tell us about your application and we can take care of the rest.

Custom plates

Standard and custom multi-well and microplates can streamline and simplify sample collection, analysis, and purification of sequencing reactions. We will work with you to develop a complete custom product including dispensing, packaging and labeling to provide you with a product that is customer-ready.

Put our team to work for you

Working with a services provider from design stage through launch can help minimize costs, trial and error and development time. You can gain access to extensive resources without the time and cost of capital investment. The Cytiva Diagnostics Services team of scientists and manufacturing specialists will help you optimize components, identify the best-suited technologies, and offer invaluable assistance to help expand your customer base and address new markets and applications that may previously have seemed out of reach.

Find out more about our genomics custom services.

In addition to our genomics services at the center of excellence in Cardiff, we also provide consultation, training and end-to-end lateral flow assay development services in our state-of-the art laboratories in Dassel, Germany. Dr Klaus Hochleitner, an industry-recognized expert in point-of-care diagnostics development, leads our team of highly-trained and experienced specialists to solve challenges and optimize your prototype development, shortening time to market. The Cytiva Diagnostic Services team makes getting from idea to proof-of-principle as speedy as possible without compromise.

A legacy of technical services

Cytiva Diagnostic Services builds on our Fast Trak services legacy, which spans many Life Sciences disciplines. Fast Trak services includes a global workforce of over 80 scientists and technology experts in Bioprocess, Genomics & Cellular Research, and Cell and Gene Therapy fields, a scale and breadth of expertise focused on accelerating our customers speed to market.