/research-services

Figure 1. Confirmatory assays are performed to validate the antigenicity of tissues prior to use in a tissue cross reactivity assay (TCR).One such test involves the immuno-staining of tissue with von Willebrand Factor (vWF) antibodies. Figure 1 shows the binding of vWF tomicrovascular endothelium proteins in renal, thyroid, bronchus and heart specimens that have been selected for use in our TCR assay. .

Asterand Inc. (US Toll Free) 1.866.384.7783 www.asterand .com

For more than 15 years, Asterand ’s PhaseZERO® Drug Discovery Services platform has provided human tissue-based solutions to leading pharmaceutical and biotechnology companies, generating the data they need to support decisions for advancing the best targets.

Asterand also has a heritage of tissue procurement. As a leading global supplier of well characterized human tissue, we are specialists in the procurement, assessment, characterization and the use of human biospecimens for research. We have sourced all the human tissues recommended for testing by the Food and Drug Administration (FDA) and the European Medicines Agency (EMA). This tissue set, which has been fully consented for commercial research, has been pre-assembled from 3 male and 3 female donors (where applicable) and has been rigorously qualified to meet the exacting needs of pharmaceutical research.

This unique combination of capabilities forms the pillars of our Tissue Cross Reactivity (TCR) service. Clients may elect to have the studies conducted under non-Good Laboratory Practice (non-GLP) or full GLP conditions. Our TCR service provides clients with an accurate assessment of the cross reactivity of their therapeutic antibody candidates with selected human tissues. Our scientists are experts in their fields. This expertise, combined with a tailored scientific approach, enable us to deliver high quality data to our clients in a defined time to accelerate the development of their therapeutic antibody candidate programs.

Analysis of f ssays

FFigure 1. Confirmatory assays are performed to validate the antigenicity of tissues prior to use in a tissue cross reactivity assay (TCR). One such test involves the immuno-staining of tissue with von Willebrand Factor (vWF) antibodies.Figure 1 shows the binding of vWF to microvascular endothelium proteins in renal, thyroid, bronchus and heart specimens that have been selected for use in our TCR assay.

Renal Cortex Secondary Bronchus

e

normal morphology2.

3.

20x 10x10x

Thyroid Gland Heart Ventricle10x 20x 10x 20x

20x

Examination of site audit to ensure compliance with ethical, legal and regulatory requirements

4. Tissue authenticity testing (as recommended by the FDA) available to confirm binding, upon request

p

to the or other Regulatory Authorities.

Asterand Bioscience Inc. (US Toll Free) 1.866.384.7783 www.asterand .com

Ref-Ab Test-Ab Ref-Ab

1 g/ml

0.5 g/ml

0.25 g/ml

Human-lgG

Positive control tumor Negative control normal tissue

Bio

Renal cortex (Test Item) Pituitary gland (Test Item)

Renal cortex (Control Item)Thyroid gland (Test Item)

and

- bronchus and parenchyma and

e

donors available immediately for studies

Prostate gland (Test Item)

Placenta (Test Item)

GL

Selection of control tissues/cell lines

Testing of 2 fixation protocols

Testing of up to 5 primary antibody concentrations

Non-immune IgG controls run in parallel

Assay control; FITC conjugated or biotinylated anti-beta actin run in parallel

Expert analysis. recommendation of optimal IHC conditions

Human-lgGTest-Ab2

Image of a single block from an Asterand frozen TCR Microarray

Prostate core

s

Asterand Inc. (US Toll Free) 1.866.384.7783 www.asterand .com

Tabular report with secure online access to Aperio scanned images - suitable to identify 'off target' effects

I am also the single point of contact for you, the study sponsor. This means I will keep you informed of any changes or issues that crop up during the running of the study. Regular communication with research sponsors is key. In order to ensure the smooth running of your (critically important) study, I strive to understand exact requirements and build a mutually trusting relationship. I treat your study as if it were my own – it’s not just a conveyer belt to me – each study is unique and valued. As the final sign-off on the study report, I personally take responsibility for the statement that the work was done in full compliance with GLP. If I’m not 100% certain of the integrity of the data, I won’t sign, so I have to make sure I review the data thoroughly as the project progresses. It’s a role that comes with much responsibility.

Bio'

5 Bio

f im Bio f Me

( , had a recent, February 2015

Bio

i

m

two and

NDA

m

Bio

/research-services

nited States

A