LifeSpan provides high-quality, confidential, protein localization data through its immunohistochemistry services.
Reseachers can outsource the entire localization process without having to worry about finding and characterizing target
specific antibodies, sourcing and validating difficult-to-find tissues, and having the ability to interpret the resulting
immunostaining in relation to complex human pathologies. Researchers can choose from a variety of standardized IHC services
that are commonly requested (Service Packets), or work with LifeSpan to custom design a study plan that will address their
particular biological question. All studies are conducted under R&D conditions, are confidential, and the results are
proprietary to the customer.
All custom protein expression-profiling studies are confidential, are performed on a fee-for-service basis without royalties or milestone payments,
and include the following:
| Study Design: |
Each contract research study begins with a customer
consultation to define the study goals, available resources, and the optimal
scientific approach. LifeSpan has conducted thousands of localization studies
for more than 100 companies worldwide, experience that can be applied to help
ensure a successful study. |
| Antibody selection and validation: |
Antibodies can be provided by the client, purchased
from a commercial resource, acquired from LifeSpan's
antibody catalog or
custom generated by LifeSpan. |
| Tissue selection and validation: |
Tissue specimens are selected that will best answer
the biological question. Normal and diseased, frozen and formalin-fixed, human
and non-human tissues can be supplied by the client, acquired from LifeSpan's
extensive Tissue Bank, selected from LifeSpan's
inventory of
tissue microarrays, purchased from
commercial vendors, or collected prospectively by LifeSpan for use in the
study. LifeSpan also offers custom tissue microarray design. Prior to use in
any study, all tissues are subjected to rigorous testing to ensure proper
fixation, accurate diagnosis, and antigen validation. |
| Assay Optimization: |
Antibodies are initially tested in Phase I to
ensure that they are working appropriately before being used to screen the
selected test tissues in Phase II. This involves performing a serial
dilution of the antibody to establish the optimal staining concentration.
Optimizing antigen-retrieval conditions may also be necessary to improve the
antibody's signal-to-noise ratio on tissue samples. |
| Immunohistochemistry: |
During Phase II testing, antibodies are used under the
optimized assay conditions to immunolabel the selected tissues of interest.
LifeSpan can use single or multiple antibodies to provide co-localization
information. LifeSpan has extensive experience in double labeling and can
recommend markers for differentiating specific cell types. |
| Interpretation: |
The resulting immunolabeled slides are interpreted by
LifeSpan's staff of pathologists, who have many years experience interpreting
the often complex behavior of antibodies in IHC. The cellular localization
profile is then correlated with the normal and/or disease processes being
evaluated. |
| Detailed Reporting:
|
LifeSpan has a flexible report format that allows for customization depending
upon the level of interpretation required. The two most common forms are Full
Text and Tabular reporting.
Full-Text Reporting: With Full-Text Reporting, LifeSpan's pathologists
describe the immunolocalization patterns in detail and provide 3-5
representative images for each tissue sample. This format is useful for studies
that require detailed observations and interpretation, such as studies
involving CNS tissues, co-localization studies, or those that may involve rare
events and minor cell types. Information about each patient sample is also
provided.
Tabular Reporting with and without Imaging: With Tabular Reporting,
LifeSpan's pathologists quantify the signal present in major cell types within
each tissue sample using a 0-4 scale and present the results in a table. This
format is useful for studies at the initial stages of target characterization,
screening studies, or those involving major cell types or in homogeneous
tissues. Customers can choose to include selected images for each tissue
sample.
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| Study Deliverables:
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Upon the conclusion of each study, LifeSpan will
provide a report detailing the assay condition, the antibody dilution
specifications, and localization results for each tissue specimen assayed.
If available, selected patient information, including the age, sex, cause of death or
surgery, is provided with each sample. LifeSpan offers a variety of reporting
formats to meet the varied needs of our customers. Reports are delivered via
a secure website and can also be delivered on CD.
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| Timeline:
|
Standard IHC studies take from 3-12 weeks to complete,
depending upon the complexity of the study. LifeSpan strives to complete our
customers' work in an expeditious manner.
|
| Cost:
|
LifeSpan offers unparalleled quality and competitive
pricing for its contract research services. Due to the variable nature of these
studies, a custom price is quoted for each study.
|
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Plan a Study:
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LifeSpan has designed the following service packets
so that its customers can order commonly requested study plans quickly and
easily. Just send us your antibodies and we’ll return the data! Each study can
also be customized to include multiple antibodies, to combine tissue lists, or
to specify the level of interpretation.
|
Each service packet includes the following:
- Selection and IHC characterization of 1 client supplied antibody*
- Delivery of an antibody characterization report
- Antigen preservation testing of the LifeSpan supplied tissues with control antibodies
- Verification of pathology and fixation quality of the LifeSpan supplied tissues
- Immunolabeling of the LifeSpan supplied tissues with the 1 antibody
- Appropriate study controls (secondary antibody without primary)
- Interpretation of the immunolabeling by a LifeSpan pathologist
- Delivery of a final localization report including digital images
* Commercial antibodies can also be supplied by LifeSpan at additional cost.
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Available Service Packets:
|
Protein Expression in Normal Human Tissues
Normal tissue profiling is intended to provide information about what normal tissue and cell types express a protein.
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Protein Expression in Cancer
The following service packets
are intended to provide information about which types of cancer express a protein, how that expression compares
to the normal tissue state, and whether that expression differs within a patient population or as the disease
progresses. Analysis is restricted to tumor cells within the cancer specimens (as opposed to tumor associated
cell types such as blood vessel endothelial cells) and the corresponding progenitor cell types within the normal
specimens.
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Protein Expression in Metabolic Disorders
The metabolic disorder profiles are intended to provide information about the differential expression of proteins
within various normal tissues and those affected by a metabolic disorder.
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Protein Expression in Inflammatory Disease
The inflammatory disorder profiles are intended to provide information about the differential expression of
proteins within various normal tissues and those affected by an inflammatory disease.
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Differential Protein Expression Across Normal and Disease
Differential profiling is intended to establish if there is differential expression in
cancers compared to the normal. These evaluations are conducted
using full specimens rather than smaller specimen cores (like those used to make up tissue microarrays). Full specimens are necessary for
the evaluation of more diffuse pathologies such as inflammatory disease and neurological disorders, as well as for the analysis of cancer
related phenomena such as field effects, progression, apoptosis, and tumor-associated angiogenesis.
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Protein Expression in Non-Human Tissues
Normal tissue profiling is intended to provide information about what normal tissue and cell types express a protein
across multiple species.
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Protein Expression based upon FDA Recommendations
The following assembly of specimens is a formalin-fixed and paraffin-embedded (FFPE)
representation of the list of normal tissues recommended by the FDA for Tissue
Cross-Reactivity (TCR) screening of therapeutic antibodies as outlined in their document “Points to Consider in the Manufacture and Testing
of Monoclonal Antibody Products for Human Use.” A true TCR study is conducted using frozen specimens (see CR0037) and provides information
about antibody binding. In contrast, this service packet is intended to provide valuable quick information about the distribution of target
proteins across the same list of FDA recommended normal tissues at less cost than a full TCR screen.
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