How We Can Support the Drug Development Pipeline

Biomarker Assay Development

Source BioScience offers state-of-the-art genomics facilities, underpinned by tissue analysis laboratories to provide prognostic, diagnostic and therapeutic testing supporting drug discovery and patient enrichment for clinical trials. Our fast throughput histology, staining and image analysis platforms can provide pharmaceutical and biotechnology companies with rapid, high quality results to facilitate biomarker validation for FDA submission and clinical research studies. Using the most advanced scientific knowledge and molecular biology techniques, support is offered for patient stratification for clinical trials as well as development of new surrogate biomarkers for cancer and other therapeutic areas. Our services include:

• Biomarker assay development and validation (tissue, serum and molecular)
• Preclinical screening using FDA and FDA European lists for cross reactivity profiling
• Tissue pathology analysis and expert review to validate tissue biomarkers
• Whole genome analysis/ genotyping for molecular markers
• Antibody development and validation of antibodies for serum assays

Biomarker assay development in Tissue

SourceBioScience offers an expertise in tissue biomarkers, supplying services for such studies as well as histopathology since 1996. We have built up a wide range of validated biomarker assays on various tissues providing our clients with rapid and more cost effective support since validation has already been completed.

An overview of the validation procedure can be accessed by clicking here

Quantitative immunohistochemistry (IHC) as well as FISH analysis on a variety of platforms is offered.

This is supported by automated image or by eye analysis providing data on density and expression of the biomarker of interest in different cell compartments (cytoplasm, nucleus and membrane), as well as different areas of the tissue under investigation. An example of EGFR in skin is given here since skin is often used as a surrogate for oncology studies.

We can work with commercially available antibodies or proprietary antibodies providing advice and expertise as to the best way to develop and validate your chosen antibody for your studies.

To discuss your requirements further please contact us at: pharma.

Pre-clinical testing

We can provide cross-reactivity testing for small molecules and antibodies against FDA and FDA/European recommended lists of tissues.
Our senior scientists will work with you to discuss the best requirements for your studies and devise a study protocol.
Your antibody/small molecule will be tested against the appropriate tissue list and images and data collated to provide you with a comprehensive overview of cross reactivity and where your antibody/molecule is expressed.
Samples/slides can be stored as required.

Tissue pathology

Basic histology services include processing of tissue to block, sectioning; H & E and pathology review are offered. Specialist staining including quantitative IHC and FISH can be supplied together with manual and automated image analysis.

Blocks/samples can be stored for clinical trials and research studies if required.
Please note that genomic extraction and rescue of genomic material from archived blocks is another service that we offer.

For further information please contact us at: pharma.

Molecular markers

Our molecular scientists worked on the human genome project and have a wide range of experience in molecular markers and can provide whole genome analysis or DNA sequencing to determine mutations of interest.
For further information on how we can help with studies to determine and validate molecular markers, please contact us to discuss in more detail.

Source BioScience already has a range of validated molecular markers which are used to enrich patients for clinical trials.

For further information on these please click on the appropriate link below

• KRAS
• BRAF
• PI3K
• EGFR

Serum Biomarker Assays

Source BioScience can provide assay development and validation for a range of antibodies and therapeutic areas.
Our experts will discuss with you the requirements and end points for your study. An initial feasibility study to test the robustness of antibody can be developed and then validated for PK/PD purposes.
We can also develop assays in a format which can be used in a clinic for trial purposes.

To learn more about our biomarker assay service please click here.

For further information please contact us at: pharma.