Antibody Conjugates
Antibody Conjugates
Antibody Conjugates
Our Range of BioReagents
Recombinant Antibodies
Recombinant Antibodies
Randox is the primary manufacturer of high-quality recombinant immunoglobulins including IgG, IgA and IgM isotypes which are expressed using a proprietary CHO cell technology
We offer a range of recombinant human, sheep and mouse antibodies which are validated in a range of traditional immunoassay formats, western blots and as control reagents in infectious disease and autoantibody serological assays.
Our Range of BioReagents
Protected: ConcizuTrace Laboratory Network Resource Hub
SdAbs
SdAbs
SdAbs provide a new mechanism for the generation of antibody therapeutics and offer numerous advantages such as better tissue penetration, ease of expression, stability and uniformity of product.
They also have benefits in traditional settings, due to their small size a much higher coating concentration can be achieved for assay development.
Research & Therapeutic Applications
Our Range of BioReagents
Conjugates
Conjugates
Randox’s antigen-HRP conjugates are optimized for use with Randox polyclonal antibodies for the development of immunoassays. All HRP-conjugates are provided in a conjugate stabilising solution, specifically formulated in-house to prolong the shelf-life of newly conjugated material, enhancing the conjugate’s overall performance and reliability within your immunoassay.
Our Range of BioReagents
Recombinant Proteins
Recombinant Proteins
Every time a gene is introduced into a plasmid and transformed in various biological systems such as bacteria and mammalian cells; it expresses to produce recombinant proteins. The production of such proteins in prokaryotes provides multiple advantages, such as low cost, rapid cell growth, high yield, and a relatively short expression period.
On the other hand, whenever a protein is required with post-translational modifications and precise folding, mammalian cells are chosen as the expression hosts. With a wide range of tags used, it is ensured that the expressed proteins are purified to a high standard.
Our Range of BioReagents
Monoclonal
Monoclonal Antibodies
Randox Biosciences offer an extensive range of monoclonal antibodies against biochemical markers, drugs of abuse and drug residues for use in both research and pharmaceutical development.
Using sheep as the host species, Randox are able to offer an alternative to current monoclonal antibodies available on the market.
Producing a wide range of monoclonal antibodies, our products offer several advantages including specificity in producing high quality antibodies for a required target with high affinity.
Our Range of BioReagents
CDx & BioPharma Services
CDx & BIOPHARMA SERVICES
Offering a collaborative CDx partnership approach.
As an established IVD company, Randox Biosciences offers tailored development and testing solutions to support faster, more effective and safer development of new drugs.
We have a wide range of in-house capabilities, ranging from the selection and patenting of novel biomarkers; manufacture of bioreagents; production of single and multiplex RUO and IVD grade tests; quality control; provision of clinical laboratory services; regulatory expertise and worldwide distribution.
Why Partner with Randox?
Pharmaceutical and biotech companies are increasingly investing in the research and development of new therapies to address the world’s growing need for earlier and more effective patient treatment.
Randox Biosciences is dedicated to the improvement of personalised diagnostic, prognostic, and predictive assays. We aim to help Pharma Biotechs and CROs move away from a “one treatment fits all” approach and help get a better understanding of the complexity and variability of diseases and increase efficacy of treatment. A key element to realizing the potential for personalized medicine is companion diagnostic (CDx) development. Randox have key expertise in all elements of CDx and diagnostic development and offer a fully flexible partnership to accommodate your needs, providing you with tailored protein & molecular assays.
Randox Biosciences can be your CDx and biomarker assay development partner from early phase trials through to drug launch, addressing all assay requirements in the process, including development of raw materials and assays, verification and validation studies, clinical trial sample analysis, regulatory submissions and co-commercialisation.
Complete CDx Partner Approach
CDx Assay Formats
Randox Biosciences is focused on advancing precision medicine through high quality, flexible assay development. We can offer the full package of Diagnostic and CDx assay development with a range of technologies and platforms for use in clinical trials.
We invite researchers to design their specific multiplex custom array, containing selected biomarkers, ensuring maximum output from a limited sample supply. Our proprietary multiplex biochip array technology can be used in early exploratory biomarker stages and can be brought through to IVD/CDx grade.
CDx Drug and Diagnostic Development Process
Development of Raw Materials
- Extensive portfolio of over 900 products for R&D applications
- Products manufactured under ISO13485 accreditation including mAbs, PAS, HRPs, sdAbs, scFvs
- Capable of custom antibody and protein development
Assay Development
- Randox offer a range of technologies and platforms for use in clinical trials
- Our Biochip technology can be used in early exploratory biomarker stages and brought through to IVD/ CDx grade.
- Comprehensive OEM capabilities for developing assays on any platform.
- Assays developed under full design control and ISO13485 accreditation
Sample Testing
- ISO17025, ISO15189 and GCP accredited laboratories located throughout the UK, Ireland and USA.
- Randox Clinical Laboratory Services (RCLS) can be used to meet bespoke sample analysis needs.
- Strong global network with 3rd party laboratories to ensure clinical trial requirements are met across the world.
Verification & Validation
- Performance of in depth multi lot verifications following CLSI guidelines to ensure full performance requirements are met
- Provide support for regulatory submissions and approvals
- Validation of assay performance and reproducibility across multiple sites
Regulatory Submission
- Experienced in-house regulatory teams provide FULL regulatory support preparing IVD/ CDx submissions and applications for approval.
- Regulatory and Development teams work closely in collaboration with the pharma partner to ensure a timely submission while keeping in line with country specific requirements
- 954 licences across the globe and over 3800 licensed products
Commercialization
- Pre and Post launch support with laboratory, clinician, patient and KOL engagement.
- Strong global laboratory and distribution networks, in house sales and marketing teams, with operations in over 145 countries.
- Capable of manufacturing customised sample collection kits under full design control
Randox Platforms
Why are Neutralising Antibody tests important now?
SARS-CoV-2 Neutralising Antibody Test
SARS-CoV-2 Neutralising Antibody Tests
–
Measuring neutralising antibodies to Wild Type (Wuhan) & Delta variants following vaccination or natural infection
Accurate indicator of protective immunity against SARS-CoV-2 variants
The Randox CE marked SARS-CoV-2 Wild Type Surrogate Virus Neutralisation Assay (EV4454) and Delta SARS-CoV-2 Surrogate Virus Neutralisation Assay (EV4477) detect antibodies that block interaction of the spike protein receptor-binding domain (RBD) and angiotensin-converting enzyme 2 (ACE2).
Rapid, high throughput tests that measure neutralising antibodies against circulating SARS-CoV-2 variants are of significant interest to Clinical, Pharmaceutical, Government and Research organisations. Vaccine breakdown is of growing concern globally with the emergence of SARS-CoV-2 variants such as the now dominant Delta strain. Randox have available innovative testing solutions to accurately measure protection against infection and to identify individuals where booster vaccination is required. This can help reduce infection rates and onward virus transmission by ensuring sufficient levels of herd immunity.
Ordering Information
Assay | Cat Code |
---|---|
Wild Type SARS-CoV-2 Surrogate Virus Neutralisation Assay | EV4454 |
Delta SARS-CoV-2 Surrogate Virus Neutralisation Assay | EV4477 |
Evidence Investigator Analyser | EV3602 |
Available Platform
Evidence Investigator
Specificty of 100% and sensitivity of 98% compared ro coventional virus neutralisation tests
Semi-automated solution suitable for medium to high throughput testing
Direct sample addition to biochip well. No off-board sample incubation required
Results available in 1.5 hours without the need for biosafety level 3 cabinet
Limited sample volume requirements
Comprehensive immunoassay and molecular test menu available
Randox Clinical Laboratory Service (RCLS)
RCLS specialise in offering an esoteric biomarker testing service, utilising the experience and knowledge Randox has built over 40 years of producing high quality in vitro diagnostics.
RCLS strive to provide a clinical laboratory testing service to meet the time sensitive, bespoke requirements of research and clinical trial projects globally.
Accredited laboratory service
Cost effective solution
Offers greater flexibility
Related Products