Using Affimer® technology to fast forward your product development
Avacta has established commercial relationships with IVD development companies worldwide for whom Affimer® reagents are providing an ideal platform for development. We also offer a custom development service utilising the Affimer® platform for diagnostic applications.
Avacta announced a commercial partnership with Mologic in February 2021 to accelerate to market Avacta’s AffiDX® SARS-CoV-2 lateral flow rapid antigen test. Avacta will also support antigen testing in low and middle income countries by providing access to Avacta’s spike test through Mologic. The partnership also provides a framework agreement for the future development of a pipeline of tests in a range of disease areas.
“Mologic offers a highly versatile range of scientific and manufacturing services for the development of diagnostic technology. We are very pleased to be working with Avacta to apply our expertise in this important project and look forward to it paving the way for further collaborations.” – Mark Davies, Chief Executive, Mologic
In April 2021 Avacta entered into a global distribution agreement with ABCAM plc to sell the SARS-CoV-2 research ELISA Affimer® reagents.
ABCAM is one of the world’s leading suppliers of high-quality biological reagents and kits which are used in a wide range of fields including drug discovery, diagnostics and basic research. Under the worldwide, non-exclusive distribution agreement, ABCAM will enable the global research community to access Avacta’s SARS-CoV-2 spike protein Affimer® research reagents through its on-line catalogue. This will allow scientists around the world to perform the ELISA test in their own laboratories and support the global fight against the pandemic.
In December 2020, Avacta announced that it has entered into a license agreement with Astrea for the use of the Affimer platform in affinity purification applications. Astrea is a leading provider of affinity separation solutions to the pharmaceutical and biomanufacturing industries. Following Astrea’s successful evaluation of Affimer® reagents for affinity separation, the two companies have entered into a non-exclusive license agreement for the use of the Affimer® technology in this field.
“Affimer® reagents are high-performance proteinaceous ligands that have been engineered for a wide range of applications as superior alternatives to antibody-based ligands. They can be used to selectively bind difficult targets, even where antibodies and aptamers have shown limitations. In combination with our proven Mimetic Ligand® chemical ligand libraries, the Affimer® ligand platform significantly expands our capacity to discover, develop and deliver custom affinity adsorbents for purification of biotherapeutics and advanced therapies.” – Steve Burton, President, Astrea Bioseparations
In response to the SARS-CoV-2 outbreak in 2020, Avacta entered into a collaboration with Adeptrix to develop a high throughput COVID-19 antigen test using Adeptrix’s proprietary bead-assisted mass spectrometry (BAMS™) platform. Adeptrix’s novel BAMS platform uses Affimer® reagents to capture the virus and viral proteins from patient samples and combines this with the power of mass-spectrometry analysis to provide a highly sensitive and specific diagnostic test.
“I am pleased to have Avacta recognise the promise of the BAMS technology with respect to its sensitivity, accuracy and high throughput capacity. I have worked with Affimers® previously and have found them to be excellent immunoassay reagents, so we are looking forward to implementing the SARS-COV-2 Affimers in a BAMS diagnostic test.” – Dr. Jeffrey C. Silva – Director of Product Development, Adeptrix Inc
In January 2021 Avacta entered into a collaboration with Bruker Corporation to evaluate the Affimer®-based, bead assisted mass spectrometry (BAMS™) SARS-CoV-2 assay, that the Group has developed with Adeptrix Inc. Bruker is one of the world’s leading analytical instrumentation companies providing high-performance scientific instruments and high-value analytical and diagnostic solutions to scientists globally. It is also one of the foremost suppliers of mass spectrometers with a significant installed based in clinical microbiology laboratories in hospitals world-wide. The collaboration will assess the suitability of the test as a professional-use in-vitro diagnostic (IVD) product for SARS-CoV-2 infection to run on Bruker’s MALDI-TOF instruments for sale in the UK and Europe.
The custom development process utilising Affimer® technology
Here is an overview of how we would manage a custom development service for diagnostic applications utilising Affimer® technology:
- Wide range of target applicability:
- Proteins (Immunoglobulins, membrane proteins, secreted proteins, specific domains, enzymes, serum proteins, kinases)
- Small Molecules/Chemicals (e.g. TNT, diclofenac, peptidomimetics, posaconazole)
- Inorganic material (magnetic nanoparticles)
- Low target consumption – the typical process requires <100 ㎍ of target protein
- Incoming targets QC’ed for purity, biotinylated and tested for biotinylation levels.
- Robust and well understood method using a truncated p3-fusion in the M13 phage.
- Typically 3 rounds of phage display. Selection biased in P2 and P3 to select for low off-rates.
- We routinely identify binders with <50nM Kd.
- Flexible approach in that it is possible to: Compete against related targets, vary format of target between selections, selection in buffer matched to end use, selection in presence/absence of associated ligands and screen mutant vs wild type.
Cloning and Formatting
- The phage display output is mini-prepped and the Affimer population is cloned into an expression plasmid. This allows flexibility to add tags etc. early in the process.
- Our high throughput picking and expression process allows us to assay Affimer proteins in their final format from the start of characterisation.
- No issues from assaying still on phage (multivalency, stability etc.) Nominal capacity to process ~270,000 clones per year.
Rapid Binding Screening
- Our primary screen is a bead-based high throughput iQue flow assay.
- Each clone assayed against up to 15 targets, in a fully automated 384-well plate assay.
- Protein-protein interaction inhibitor assays are available as part of the primary screen.
- This screening method offers many advantages including low target consumption (e.g. to assay 768 clones just ~7µg of target material is needed) and speed (assays can be completed in less than ½ a day).
- Primary screen data and an indication of relative clone expression levels are available by the end of week 4.
- We are currently implementing SPRi (Horiba XelPleX) and kon/koff for the clonal repertoire of each project.
- Hits from the primary screen are sequenced and unique sequences bulk expressed before moving into validation.
- Range of assays available in-house, including; fluorescence microscopy, flow cytometry, cell-based inhibition/activation assays, high-throughput pull-down assays, mass spectrometry and IHC.