Services
Our team has experience with de novo assay development, technology transfer, optimization and validation. We work with biological matrices from human. Assays validated within our lab include reports customized to your exact requirement.
Pre-clinical Studies
Cell Culture
We offer our clients Cell Culture of mammalian cells, production of cell lysates, cell transfection, protein expression, purification and mid-scale production. For protein expressions we follow customer SOP’s. CBL has a state-of-the-art cell culture lab, which is used for production and purification of any kind of biologics. Detection and qualification of the biologics is done by the CBL process development team.
- Cell culture of mammalian cells scale-up
- Protein expression per customer SOP
- Cell lysate production
- Upstream and downstream development process
- Development and validation of cell-based assays
Assay and Research Services
We are specialized on immunoassay development and validation. In CBL we understand the importance of the immunoassays in the process of discovery a new drug.
If you have trouble finding a commercially available ELISA kit for your antigen of interest or having problem developing in-house ELISA assay, The CBL team can help you developing, qualifying and validating ELISA screen and confirmation assay. The entire validation package will be accompanied with a written protocol, a quality management system (QMS) to ensure consistent quality results and stability studies as required by the clients.
Autoimmune Antigens
At CBL we place special emphasis on differentiated segments of therapeutic areas. These areas are the production and purification of autoimmune antigens from native sources, e.g. Voltage Gated Potassium Channels (VGKC) and Voltage Gated Calcium Channels (VGCC) from rabbit brain tissue, Nicotinic Acetylcholine from mouse tumor. We are equipped to prepare any autoimmune antigen from any native source.
Development of non-clinical process
Non-clinical studies conducted using different protocols and following Good Laboratory Practice (GLP), aiming to provide Client´s drug candidates, safety information including toxicity, mutagenicity, pharmacology and general toxicology.
Analytical Tests
CBL offers comprehensive routine analytical services and tests, with modified and standardized analytical methods for applications to specific samples, and new techniques. Our analytical capabilities, ranging from chromatography, electrophoresis, mass spectrometry and spectroscopy, as well as our cutting-edge technologies are built to support clients and solve the most challenging problems for their molecules.
Immunoassays
Our immunoassays, designed using Traditional Enzyme-linked Immunosorbent Assays (ELISA) and other newer methods for easy-to-run, high-performance, sensitive and target-specific, offer the analyte specificity of antibody–antigen binding with the signal detection and high adaptability that can be applied to many formats depending on the needs of the end user.
Clinical Studies
Autoimmune Antigen Expertise
Caribbean Biotech Labs (CBL) has decades of expertise and strong capabilities on biologics purification. We are experts at preparing any kind of biologics and providing nonclinical end-to-end drug development services, offering a comprehensive panel of autoimmune disease antigens with a proven track record for quality and sensitivity in Radioimmunoprecipitation assays. Maintaining a Lot-to-lot consistency of these native antigens shortens both assay development and validation process. Plus, all of our autoimmune disease antigens are prepared under Good Laboratory Practices (GLP) regulations.
| Antigen | Clinical Association | Source |
|---|---|---|
|
Voltage-Gated Calcium Channels (VGCC) |
Paraneoplastic Neurological Syndrome, (PNS), Lambert-Eaton Myasthenic Syndrome, (LEMS) |
Rabbit Brain |
|
Voltage-Gated Potassium Channels (VGKC) |
Paraneoplastic Neurological Syndrome, (PNS), Autoimmune Encephalitis |
Rabbit Brain |
|
Ganglionic AcetylCholine Receptor (gAChR) |
Paraneoplastic Neurological Syndrome (PNS), Autoimmune Autonomic Gangliopathy, (AAG) |
Human Neuroblastoma Cell Line, (IMR-32) |