Cureline Inc.

Cureline procures, ships, stores, analyses and distributes thousands of human specimens every year. Our major biorepository is located in the United States and high-quality human specimens are immediately available to our clients and collaborators.

Our team collaborates with the major clinical and research centers in Europe, Asia, and the USA on developing collection protocols that are approved by local IRBs and Ethical Committees and that comply with international and local regulations and guidelines.
A standard patient consent form is used for all Standard Collection Protocols. Project-based consent forms are developed for each custom study in collaboration with clinical sites and the study sponsor. Standard Operating Procedures (SOPs) are implemented to guard patient’s rights and to use the samples with maximum efficiency.

All human materials provided by Cureline are properly consented, de-identified and selected with accurate clinical diagnosis and therapy regimens by certified medical professionals. Standard clinical information provided for each case includes age, gender, diagnosis, pathology report summary and treatment history.
If requested, a custom clinical report form (CRF) is developed and implemented in prospective procurement studies. A detailed pathology report from a US-board certified medical pathologist and H&E slides can also be provided upon request

Quality:
Our standard procurement protocols accommodate the quality requirements of most research methods used in the drug discovery and development process. Cureline guarantees the quality of all provided human materials and services.

Specimens include:
FFPE Blocks: FFPE tissues (Oncology, Inflammation, Neurological Diseases, Normal Tissues)
Frozen Tissues: FF tissues: Oncology, Inflammation, Neurological Diseases, Normal Tissues
Blood and Bone Marrow: Human specimens from patients with leukemia, multiple myeloma, MDS, etc.
Cell Fractions: Primary human viable cells and marker-specific cellular sub fractions for functional studies and expression analysis
Primary Cell Lines: Primary cells cultures from solid tumors, cancer blooc, cancer bone marrow and normal tissues (custom protocols and available products)
Biospecimen Sets: Comprehensive human specimen sets from patients with solid tumors, hematologic malignancies, rheumatoid arthritis, endometriosis. Normal human tissue panels.
Treatment-Relevant Serum: Collection of treatment-relevant cancer serum with clinical outcome data
Human Therapeutic Plasma: Cureline provides human therapeutic plasma for diagnostics development and validation.

Drug discovery companies focused on molecular targeted therapies face challenges in building state-of-the-art programs geared towards the identification of specific molecules (lipids, proteins, enzymes, etc.) which may play critical roles in governing human diseases, such as asthma and rheumatoid arthritis thereby providing rational molecular targets for therapeutic intervention. As a starting point, a drug discovery platform may identify targets using advanced genomics techniques and bioinformatics capabilities. Once targets are validated in relevant in vitro and in vivo disease models, lead drug candidates, obtained by target-driven screening, may be optimized using crystallography and computational chemistry.

Human specimen acquisition is now a critical step for research activities involved in target validation, drug discovery and clinical development. Using human tissues for research e.g. for molecular target expression/activation, can provide key data from early stage discovery through pre clinical research drug safety evaluation, biomarker development, patient pre-selection and entry of novel compounds into the clinic. At the gene and protein expression level, human tissues can be used to identify specific molecular entities involved in human disease (e.g. in cancer those regulating tumor growth, metastasis, drug resistance). Along with preclinical development work on the mechanism of action for lead compounds, the information obtained from studies with human specimens greatly facilitates the design of early phase clinical trials, assisting in the identification of the patient population that would most likely benefit from the targeted experimental medicine.

To enable decision-making that potentially could reduce attrition and save millions of dollars in the drug development process, examination of a broad range of human specimens of diverse origin, with substantial specimen numbers from each category, is key.

Fully appreciating the value and scarcity of protocols for obtaining, handling and processing human specimens, ensuring reproducible and reliable results.

Our goal is the advancement of drug discovery development and commercialization activities, ultimately improving the outcome for patients. We offer implementation of human tissue research services.

Site Auditing. Cureline can carry out an audit of selected sites (either poor performers of sites with high potential but problematic) to identify major issue contributing to poor reliability and quality.

Cureline has established collaborations for the collection of biospecimens and the preparation of human RNA and DNA panels from diseased and normal tissues.

Our standard research protocols for human RNA/DNA isolation fulfill the quality requirements for most research methods, including SNP variations and differential expression analysis using different microarray platforms.

High definition whole slide scan

Human tissue H&E

Digital pathology

Comprehensive pathology report provided by the US board-certified MD pathologists

Image analysis (Aperio system)

Cureline has great level of expertise in providing IHC services to support your research in oncology, inflammation and metabolic diseases. FFPE or frozen specimens are strictly selected for quality and fully annotated with clinical information.

Many immunostains are routinely available along with control tissues (provided at no additional charges). The stock of commonly used reagents including primary antibody (additional charges apply or may be provided by the client) and secondary reagents (included in price) is maintained by the laboratory director and list of these reagents is available upon request. Reagents that are not on the list and unusually expensive reagents must be provided by the client.

We offer our pharmaceuticals and biotechnology clients laboratory support for toxicology studies on human and animal tissues.

Antibody cross-reactivity is tested by immunochistochemical (IHC) staining using a set of snap-frozen normal adult human tissues. High-quality post-mortem normal human tissues procured within 3 – 12 hours PMI (post-mortem interval) are required to conduct effective antibody cross-reactivity study. Carefully selected frozen and FFPE normal human tissues are available to our clients for IHC studies. Cureline provides normal human tissues procured under the same collection protocols for antibody cross-reactivity studies to leading service providers in the USA and worldwide.

As the leading commercial human biospecimen CRO Cureline can offers expert consultancy services to improve tissue collection efforts that are a part of your clinical trial:

Protocol Review. Cureline can review existing technical approaches for tissue collection to ensure that methods are consistent with the industry best practices.

Site Auditing. Cureline can carry out an audit of selected sites (either poor performers of sites with high potential but problematic) to identify major issue contributing to poor reliability and quality.

GAP Analysis. Cureline can provide a detailed report on findings on how both the document methods (protocols) as well as on site operations and logistics at select sites may deviate from best practices. This report would include a plan with recommendations for improvement and roadmap for larger scale auditing and improvement.

Process Improvement and Standardization (logistics). Cureline experts are able to provide on-site support to a selected number of sites to improve sample collection, processing, storage and distribution methods. These improvement efforts could be expanded based on need.

Site training. Cureline can provide training to clinical and scientific staff as study sites for various tissue collection, preservation and handling methods. This is based on Cureline’s extensive experience collecting thousands of tissue cases at a variety sites around the world.

Ongoing monitoring. Cureline could provide ongoing quality control monitoring of sites to ensure that sites are compliant with standard protocols.

Specimen management services. Cureline could provide services for biospecimen storage, consolidation and organization.

Cureline has established collaborations for the collection of biospecimens and the preparation of human RNA and DNA panels from diseased and normal tissues.

Our standard research protocols for human RNA/DNA isolation fulfill the quality requirements for most research methods, including SNP variations and differential expression analysis using different microarray platforms.

• Microscopic tissue slide preparation from FFPE blocks
  
• Microscopic tissue slide preparation from frozen OCT embedded tissues
  
• Preparation of microscopic slides from frozen human and animal tissues
  
• Serial and step sections (any type of tissues including mouse embryos and mouse brain)
  
• Preparation of multiple tissue samples on one slide
  

Human tissue special stains

Cureline consults on design and development of custom human tissue microarrays (TMA) for target expression and biomarker analysis in diseased, adjacent normal and normal tissues. Our team can help you to select an appropriate human biospecimen from the list of available tissues or procure a unique human TMA for your project, design and procedure, and implement your protocols for ICH and ISH analyses. Cureline also can provides access to high-quality human biopsecimens with clinical outcome data.

Cancer TMA types:
Breast
Colon and Rectum
Lung
Stomach
Head&Neck
Kidney
Thyroid
Melanoma
Ovary
Prostate
Lymphoma
Bladder
Brain

Tissue grossing and processing (for fresh and fixed human and animal tissues)

Paraffin and OCT embedding

Preparation of microscopic slides from paraffin blocks, OCT blocks and frozen tissues

Preparation of human tissue TMA

Human Tissue Services

Human Biospecimens Services

Pharmacology Services

Drug Discovery & Development Services