- United Kingdom
- Human Medicines, Biopharmaceuticals
- Service category
- GLP services, GCP audit services, …
Your company? Get access to this profile.
- Antibody services
- Biomarker / drug target validation
- Clinical trial services
- High throughput screening
- Histochemistry / immunohistochemistry
- Histology / histopathology
- Imaging / autoradiography
- Screening services
- Tissue services
Therapeutic Antibody Cross Reactivity Testing
HistologiX undertakes regulatory high throughput Cross-Reactivity testing of therapeutic monoclonal antibodies and other tissue targeting molecules in tissue from humans and other species as outlined by the US Federal Drug Administration (FDA), European Union (EU) and Japanese MAFF regulators. We hold relevant, fully consented human tissue, which has been ethically obtained from recognised suppliers under the terms of our Human Tissue Authority License (obtained 2007) and our 5 year NHSMREC UK Ethical Approval (obtained 2008) from the local Trent Ethical Review Committee.
Our IHC Team ensure optimised working conditions for each antibody prior to tissue screening. Screening involves staining 38 tissues from a minimum of 3 donors, all with test and control antibodies, the evaluated results are subject to a peer review prior to the issue of the final report. Appropriate controls are part of any study and may include, but are not limited to, positive and negative tissues, over-expressing cell lines and xenografts, negative isotype antibodies and, where available, inhibition control.
General Antibody Screening
Our IHC team have extensive experience, over many years, in demonstrating a range of general commercial antibodies in a number of different situations and can provide you with an all round high throughput quality IHC service.
Cell Signalling Biomarkers
Cell-Signaling biomarkers can be used to identify the efficacy of a therapy by demonstrating and measuring down-stream changes in the protein expression of cell regulating molecules. The Staff at HistologiX have an impressive track record in the development of antibody assays that are targeted at over-expressed proteins in diseased tissue. By demonstrating such potential diagnostic and prognostic disease markers HistologiX can support and aid your drug development programmes.
HistologiX currently provides clients with fluorescent assays including single and dual labelling IHC methods. We have used these to detect implants of human stem cells in brain tissues in a model of Alzheimers Disease. However this technology lends itself to many other uses.
Table of Monoclonal Antibodies
HistologiX can provide optimised high volume IHC screening in human tissues using an extensive range of cell signalling biomarkers, including but not limited to, those identified here;
|Cleaved Caspase 3||pERK||P16||UPAR|
HistologiX provides expert Contract Histology Services in support of regulatory pre-clinical toxicology studies, clinical trials studies, non-regulatory diagnostic, veterinary and research studies in tissue from humans and other species, as well as cultured cells and xenograft material.
The histology laboratory at HistologiX performs to a single quality standard in line with the principals of GLP and as such our procedures are fully controlled, documented and audited; with all stages of the service being undertaken by staff with extensive experience in a fully compliant GLP environment. Our senior staff members have many years experience in Contract Research Organisations’ (CRO’s) where they have performed at Team Leader and Supervisor/Manager levels and can provide practical advice on study design or consultancy services in a wide variety of different areas.
We provide quality high throughput regulatory and non-regulatory and clinical histology services to the Pharmaceutical and Biotechnology industries. All timelines are agreed in advance and every effort is made to maintain these through regular liaison and updates with the Study Sponsor.
Our aim is to provide a high quality service to our clients, to ensure this all of our histology slide production is 100% quality controlled prior to dispatch.
HistologiX has access to both in-house and consultant expert Veterinary and Medical Pathologists who support both the Innmunohistochemisty and Histology Services. Our Pathologists are available to provide in-depth scientific input into your study design, provision of expert histopathology reports and peer review reports.
HistologiX has further contacts with several private pathology service providers that allow further access to an even greater range of expert consultant Pathologists across a wide range of disciplines, hence ensuring all sample evaluation is undertaken to the highest professional standard.
HistologiX currently banks an extensive range of fully consented normal human tissue as well as tissues from other species. The tissues identified in the Regulatory Tissue Table are held by HistologiX from multiple donors and fulfil the USA FDA and EU guidelines for testing therapeutic antibodies in human tissue. Additionally HistologiX holds a number of different tumour types and through an ongoing collaboration with Tissue-Solutions Ltd is able to provide prospective collection of normal and diseased tissue types.
All human tissue is fully consented and obtained from ethically licensed suppliers. HistologiX was awarded a licence from the Human Tissue Authority in 2007 to store tissue and gained an NHS MREC UK Ethical Approval for a 5 year period from the Trent Research Ethical Committee (January 2008) to perform appropriate Regulatory and Non-Regulatory antibody screening studies.
HistologiX can currently provide basic Image Analysis on both H&E and IHC sections as well as, through our extensive experience of developing such systems, being able to advise our clients on technical issues relating to image analysis and digital scanning. We are currently evaluating various imaging and scanning systems in order to offer a far greater range of services to our clients.
HistologiX is able to provide both Histology and IHC Laboratory Services in support of all phases of clinical trials. The company is currently supporting Phase I clinical trials by providing multiple biomarker assay developments with subsequent staining of pre and post treatment biopsies.
We are currently securing a formal arrangement with a Consultant Clinical Researcher who has extensive experience of project managing phase I—IV clinical trials with major pharmaceutical companies. Through this arrangement the Company will be able to provide a more complete clinical trials service to its clients.
You might be also interested in
Sourcing this company's services?Send inquiry anonymously »