Bioanalytical and Drug Discovery Services

SBH Sciences is serving the biotechnology community for 25 years. We already assisted over 300 companies. SBH Sciences is expert in large molecules mainly cytokines, enzyme and antibodies. Our bioanalytical services assisted in the development of biotherapeutics based-on: peptides, recombinant proteins, monoclonal antibodies, T-cell engager, biologic virus-like particle (VLP), adeno-associated virus (AAV), as well as complex carbohydrate. SBH Sciences is offering to researchers many outsourcing services including Bioanalytical Services covering the development of analytical methods and the analysis of Biomarkers and Biologic Drugs using 11-platform technology. Our Bioanalytical Services are based on our expertise, and in-house innovative instrumentation. We are advancing the most complex therapeutics programs starting at the discovery and preclinical phase by providing the essential method development and culminating in the analysis of the clinical samples under GLP. Thus, we are assisting the pharmaceutical / biotechnology community throughout the entire drug development cycle. As part of our obligation, we are also assisting in drafting standard operating procedures (SOPs) and technology transfer to GMP partners in order to expedite critical deadlines.

We routinely develop quantitative bioanalytical methods to measure protein concentrations including cytokines and antibodies in biological fluid, including plasma, serum, cerebrospinal fluid (CSF), urine, and tissue from multiple species (including human, mouse, rat, pig, and NHP) . We also are working with cell culture including primary cells and blood components. We have at SBH Sciences over 500 cell lines that can be customized used for any in-vitro experiment or scale up for in-vivo work.

We are dedicated to performing accurate, reliable, and streamlined bioanalytical services for the most challenging programs to help you make confident research decisions.

Our platform technologies include:
- Analytical HPLC
- ELISA / Receptor Binding Assay / Ligand Binding Assay / ADA (anti-drug antibodies)
- Simple Western Assays [fully automatic Western Blot]
- Multiplex [Luminex and MSD]
- Simple Plex [ELLA]
- IsoLight
- Flow Cytometry Assays [FACS]

SBH Sciences applied each platform category above and performed customized research & development services for the pharmaceutical, biotechnology, medical device, and diagnostics companies. Although, we usually, are requested for the development of qualification assays, we also provided full validation assays including: specificity, precision (robustness), accuracy, dilution linearity, limit of detection (LOD), lower limit of quantification (LLOQ), upper limit of quantification (ULOQ), recovery (spiking), and stability.

Different level of validation exist. We are flexible and work closely with our customers to provide their specific needs. Please visit www.ema.europa.eu for more information.

SBH is also involved in several formulation studies of recombinant proteins.

Our services include:
- Method Development, Qualification and Validation.
- In-Vitro studies to demonstrate Proof-of-Concept.
- Analysis of animal samples and support preclinical studies.
- Analysis of samples from Human subjects (PK) and support clinical studies.
- Biomarkers analysis.

In addition to the Bioanalytical capability, we are expert in cell-based assays. We are also assisting scientist to develop Antibody Drug Conjugates (ADC) and Antibody Dependent Cellular Cytotoxicity (ADCC).

New Technology Biomarker Analysis Currently Available from SBH Sciences
We are currently offering analysis of over 90 biomarkers. SBH Sciences welcomes suggestions from researchers and encourage you to communicate with us about your particular research needs.

Please contact us to discuss your needs, and find ways in which SBH Sciences might be able to work with you. We will be happy to assist you.

SBH Sciences provides Contract Analytical, ELISA Development Kit services and Multiplex services for the R&D and IVD community. Among our services are HPLC, ELISA, RBA (receptor binding assay), ADA (anti-drug antibodies) and Western Blot. We are assisting scientist to develop Antibody Drug Conjugates (ADC) and Antibody Dependent Cellular Cytotoxicity (ADCC).

We have developed over 20 highly sensitive and accurate colorimetric sandwich ELISA Kits for the measurement of Cytokines and Biomarkers. Our ELISA Kits are already distributed worldwide.

Partial list of our kits is including the following cytokines (e.g., TNF-a, VEGF, IL-12 p70), Biomarkers / Cancer (e.g., Galectin-1, Galectin-3) and apoptosis markers (e.g., Bcl-2, Caspase-3).

We are providing custom service that will meet your specific needs. Moreover, we are providing in-house optimization to verify the impact of various serum / plasma / cell culture on your PK/PD study.

We will develop and provide a comprehensive instruction manual for performing the assay. It will include all the steps including: coating and wash solutions, blocking and secondary (conjugated) antibody. If requested, we can also perform all the testing of your samples at our facility.

Our expertise in the production of recombinant proteins and monoclonal antibodies (MAb) will enable us to produce your desired antigen and MAb and will significantly reduce the cost associated with the production / reagents. In addition, we will optimize the capture and detection antibodies to allow lower detection limit and high precision and accuracy measurement.

More about the Development and Improvement of ELISA Kits.

Validated ELISA-Based Assays Available for Immediate Use.

Automated Western Analysis Services

A major challenge in protein research is obtaining quantitative, reproducible, high content information quickly.

Since 2013 SBH Sciences and SBH Diagnostics has offered innovative automated Simple Western Blot services using the PeggySue and WES (ProteinSimple). The analysis is based on a novel protein separation using capillary electrophoresis (CE) and a very accurate immunodetection. Proteins can be separated by size as in traditional PAGE Western or by their pI as in traditional CE or isoelectric focusing.

This service is especially suited for Pharmaceutical and Biotech Companies using traditional western blots in their research, development, and QC labs. Simple Western will assist scientists in vaccine development, kinase inhibitor, cell lysate analysis (from tissue culture or tumors), and the identification and quantitation of tumor-associated proteins in precious clinical patient samples.

View our Simple Western™ Case Studies on the SBH Diagnostics site.

Benefits of the Automatic Western Service

  • Provide quantitative reproducible protein analysis with CVs under 10%
  • High throughput capability
  • Able to multiplex and normalize to standard proteins
  • Evaluate efficacy in cancer therapeutics against key cancer-associated target proteins in kinase signaling pathways
  • Stratify patient populations for clinical trials
  • Cost effective

The Simple Western™ Protein Analysis can provide:

  • Protein quantification and characterization
  • Protein Charge Heterogeneity
  • Protein Formulation & Stability Testing
  • Antibody and Antibody Drug-Conjugate Characterization
  • Gel and Blot Documentation
  • Immunoassay Multiplex Protein Detection
  • Post-Translational Modification Characterization

    The illustration below describes the Fully Automated process, for either molecular weight separation of proteins or separation by their pI. molecular weight separation

Size/Charge-based characterization of proteins has been predominately performed by either SDS-PAGE/IEF/Western blot analysis or by capillary electrophoresis (CE). Each technique has advantages –Western blotting exploits high sensitivity as well as specificity of antibody binding, and CE offers high resolution and reproducibility. The sensitivity and resolution of the results obtained from either method is often challenged by the ability to preconcentrate or stack enough protein sample before separation. Simple Western is a new size-based or charge-based separation platform that runs Simple Western assays, combines for the first time the advantages of both Western blotting and CE into a single automated workflow. Optimization of stacking conditions results in a significant sensitivity and resolution increase using the Simple Western assay.

Learn more about our new Simple Western Applications and capabilities.

Please contact us to discuss your Western Applications and our service that can provide a fully automated characterization and quantification of proteins.

Luminex / Multiplex Services
Custom Development and Testing Services of MultiAnalyte Profiling (MAP)

SBH Sciences is offering Multiplex Cytokines Custom Development and Testing Services based on our Cytokine expertise and the Luminex® xMAP Technology. The xMAP platform technology allows simultaneous quantification of MultiAnalyte Profiling including cytokines / chemokines / biomarkers in cell culture and biological samples. We are offering tailor-made assay development of Multi Arrays usually based on already available commercial assays as well as additional of new innovative biological markers. We will develop the assay and will evaluate, verify and optimize the dynamic range, signal linearity, assay specificity and will ensure Multiplex compatibility. We are also providing Customer Sample Testing Services.

Our custom assays can be tailor-made for many applications including: Cancer Markers, Cardiac Markers, Growth Factors and Transcription Factors. It might assist to assess the mechanism of action for monoclonal antibodies, recombinant proteins, small molecule therapeutics across a range of disease states including cardiovascular, inflammation, immunology, oncology, and CNS disorders.

Luminex and Luminex 200 are registered trademarks of Luminex Corporation

Our expertise in the production and purification will be applied as well. For example, SBH Sciences can assist you in the isolation of specific biomarker from natural sources or produce it as a recombinant protein while simultaneously, we will also develop your specific MultiAnalyte Method.

We are using the Luminex® 200™ analyzer (Luminex and Luminex 200 are registered trademarks of Luminex Corporation). We also can perform Cell-Based assays for you samples using over 400 different cell lines. Please see our unique Cytokine Bioassay Services.

Validated Luminex Analytes Available for Immediate Use.

Simple Plex Platform

Simple Plex Platform SBH Sciences is among the first Contract Research Organizations World Wide that are offering contract services using the Simple Plex Platform (Ella).

The Simple Plex platform is a transformative immunoassay technology which integrates an innovatively designed microfluidic cartridge with a state-of-the-art analyzer to deliver the most efficient benchtop immunoassay system along with reliable results. It brings a level of automation to the traditional ELISA by providing "sample-to-answer" test results in a sealed disposable cartridge within 1 hour while removing operator related biases. In addition, because of its unique multi-analyte capability with none of the drawbacks of traditional multiplex platforms, this platform has broad applicability in both research and clinical markets. We at SBH Sciences are offering both immunoassy platforms, the Luminex and the Simple Plex Platforms to meet customers' complete workflow in their research and clinical protein applications.

Simple Plex analysis of PD-L1

SBH Sciences is offering an accurate and sensitive measurement of PD-L1 using the Simple Plex. More than 120 validated analyses can be tested at SBH Sciences using this platform. Full list is available at:  

Validated Simple Plex (ELLA) Analytes Available for Immediate Use.

Biomarker Analysis is Available Under CLIA Guidelines

In conjunction with our strategic partner, SBH Diagnostics we can perform the test under CLIA-certified auspices. Based on CLIA regulation, any materials derived from the human body for diagnostic, treatment, health assessment or prevention purposes can be tested.

CLIA, or Clinical Laboratory Improvement Amendments, is a set of regulations administered by the Centers for Medicare & Medicaid Services (CMS) for laboratory testing of human samples. The objective of the CLIA program is to ensure quality laboratory testing through laboratory certification, personnel standards, proficiency programs, and inspections. In total, CLIA covers approximately 244,000 laboratory entities. To read more on CLIA, visit: https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/index.html

We believe in working together for our mutual success and encourage you to communicate with us.

Please contact us so we can discuss your specific needs, and ways in which SBH Sciences might be able to work with you. We will be happy to assist you.

Our expertise is your competitive edge!

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Discovery Research Products & Services
(508) 650-6218 | Info@SBHsciences.com
The World's Leading Provider of Cytokine Cell-Based Assays