Shaping the future of bioassays

Transcription

1 Shaping the future of bioassays

2 Company French Company Founded in 2010 Backed up by investment funds Situated in a business park dedicated to health developments projects within the environment of the Rouen University Hospital Campus (one hour from Paris).

3 Our Mission Develop and manufacture high performance analytical tools for the Life Science industry Supply Pharmas, Cosmetics, Biotechs, Acads Our Focus Sensitive and Multiplex Immunoassays Instruments, Kits, Custom services (prototyping) Our Stage Currently in Industrialisation phase Launch planned S Very few instruments available S before acceleration

4 Bioassays : main challenges Numerous Analytes Range of analytes abundance Volume of sample Bioassays Limit of detection Cost of reagents Human Plasma «Proteome» From Anderson NL, Anderson NG, mol cell proteomics, 2002, Nov;1(11): Robustness

5 Dynaxi : Immuno Mass Tag Analyser : Patented Technology 1) Ultrasensitive: Quantification down to zeptomoles (hundreds of molecules) : much more sensitive than traditional bioassays 2) Multiplex: Up to 25 analytes quantified in parallel in the same sample : Plasma / urine / CSF / Supernatants 3) Low volume of sample (10µL): biopsies, small tumors, cell culture 4) Dynamic Range: up to 5 log 5) Robust: Based on the counting of Symtags ( no measure of optic signal) 6) Low reagent cost: Microquantities of reagents thanks to micro-device

6 Easy to use : ELISA like standard process Human Biopsies, Plasma Cell based assays Xenografts biopsies FFPE tissues (laser microdissections) Sample collection (Protein extraction) Hybridisation of samples on device Washing then probing with detection antibodies Washing then Scanning on Dynaxi Analyser

7 Technology : Sandwich ELISA assays Symtag = element mass tag Washing Washing Washing steps Blocking step 30 min Hybridisation of sample 2H Hybridisation of mass tagged detection antibody 2H Quantification with Dynaxi reader 4H to 12H (depending on plex nb) Orbital shaker for incubation and washing steps

8 Dynaxi : Immuno-Assay Mass-Tag analyser Dynaxi Analyser : Ionisation of surfaces (scanning mode) Digital counting of selected Symtag

9 Technology : MS like detection Oxygene Source Symtag : Thullium No sensitivity to light! : Symtag = metalic mass tag

10 Dynaxi Technology vs Traditional Immuno-Assay

11 Multiplexing : Micro-devices - 96 wells x 25 spots = up to 2400 data / experiment - Compatible with automation - Volume of sample : 10 to 50 µl

12 Internal controls : E.g. : standard 5 plex design Negative Control spot (irrelevant) T3 T4 T1 T2 T5 Positive Control spots (irrelevant) Positive control +++ Positive control ++ Positive control + Negative control A Negative control B Tests Symtag (stable mass tag : no bleaching over time) Test spots

13 Evaluation of cross-reactivities: A two steps process Incubation of multiplex assay microdevice: 1. with a mix of the recombinant protein and detection antibodies incubated individually. 2. with recombinant protein incubated individually with the mix of detection antibodies.

14 Verification of cross-reactivities E.g. Verification of a 5 plex Step 1: Incubation with a mix of the recombinant proteins (1, 2, 3, 4, 5), then detection antibodies incubated individually (e.g. here well with incubation of detection Ab N 3). T1 Positive control +++ Positive control ++ T2 Positive control + Negative control A T3 T4 T5 Negative control B Tests Expected results for step 1: Signal on positive control and on T3 only. If signal on other spots = cross reactivity.

15 Verification of cross-reactivities Step 2: incubation with recombinant protein incubated individually (e.g. here std 5), then with the mix of detection antibodies (1, 2, 3, 4, 5). T1 Positive control +++ Positive control ++ T2 Positive control + Negative control A T3 T4 T5 Negative control B Tests Expected results for step 2: Signal on positive controls and on T5 only. If signal on other spots = cross reactivity.

16 Easy to handle Software:

17 Preliminary data Should be better with our Dynaxi final version

18 Our offer menu : 3 possibilities - 1/ Ready to use kits - 2/ Custom multiplexing - 3/ Custom Assay Development and Manufacturing Our Technology is OPEN!

19 1/ Ready to use Kits* HUMAN CYTOKINES INDIVIDUAL ASSAYS CXCL1 CXCL13 IL-10 IL-12p40 IL-12p70 IL-13 IL-17 IL-1alpha IL-1beta IL-1ra IL-2 IL-3 IL-6 IL-7 IL-8 LIF TNF-alpha TNF-beta TRAIL MOUSE CYTOKINES INDIVIDUAL ASSAYS CXCL1 IFN-gamma IL-17 IL-1alpha IL-1beta IL-2 IL-3 IL-6 IL-9 TNF-alpha TSLP HUMAN INFLAMMATION KIT IL-1beta IL-6 IL-10 IL-17 TNF-alpha HUMAN RHEUMATOID ARTHRITIS * 2015 assay development program KIT C7 PROS1 S100A9 Ceruloplasmin

20 2/ Custom multiplexing - Assays chosen among our catalog list Build your own multiplex device based on our simplex assays!

21 3/ Custom Assay development - Biosims opens its technology to your challenging TARGETS! From prototyping to fit-for-purpose validation : - Selection of antibodies from validated suppliers or assay development with client proprietary antibodies - Prototyping of individual assays - Assessment of basic performances (LOD, LLOQ, ULOQ, Precision, Accuracy, Range) - Multiplexing of individual assays, and cross reactivities testing - Validation : Intra-assay precision, Inter-assay precision, Matrix effect, Spike recovery,

22 3/ Custom Manufacturing Process

23 Kits production and QCs - 1/ Detection antibody labeling + Detection antibody Symtag Detection antibody labeled with Symtag QC on detection antibodies QC on Symtag QC on detection antibodies labeled with Symtag

24 Kits production and QCs - 2/ Spotting of capture antibodies Capture antibodies (1 Ab / well) + Micro-device QC on capture antibodies and micro-devices QC on spotted micro-devices One kit per batch for QC (15 kits)

25 On going developments : - Assay portfolio (targets open to discussion) - IQ OQ PQ process - Watson LIMS compliance - CFR 21 part 11

26 Looking for feed-back and close relationship with early adopters Take part of our early birds program! - Special discount Program for Preclinical studies program (Custom Assay Development) - Kits : Discounts depending on volumes, + additional discount of xx% for the first 3 years

27 Thank you for your attention Contact : Jean-Marc Bélouard, European Sales Director sales@biosims.fr jmbelouard@biosims.eu