Discovery Research Products & Services•Production of recombinant proteins, enzymes and monoclonal...
Transcript of Discovery Research Products & Services•Production of recombinant proteins, enzymes and monoclonal...
Discovery and Pre-clinical Contract Research Organization (CRO)
Innovative Biotechnology Company with Discovery Programs
Production and Bioassay Testing of Cytokines & Enzymes
Bio-Incubator : An Innovative Business Model
Models for Oncology and Inflammation
Custom Process Development
Biomarkers Analysis
September 2019
Discovery Research Products & Services
Therapeutic Areas Supported by SBH In-Vitro Models • Oncology (350 human cancer cell lines) • Inflammation (human PBMC, THP-1, Liver and BEAS-2B cells) • Metabolic diseases (Diabetes, NASH) • Neurobiology (Neurodegeneration / Neuroprotection)
Serving More Than 200 companies worldwide for 22 years
Clone Selection Cell Culture Optimization Purification Bioprocess Scale-up Formulation Manufacturing
Target ID
Assay Development Primary
Screening Secondary Screening Lead Optimization PK/PD
Instrumentation • 2D Western Blot • Luminex 200 • Simple Plex (Ella) • Fully Automatic ELISA Workstation • Analytical HPLC • qRT-PCR • Vitros 350 analyzer • Irradiation Capability • FACS
Biological Resources • 350 human tumor cell lines • > 30 oncology drugs • > 300 cytokine potency assays • 30 Recombinant cytokines • 8 Recombinant enzymes • 40 Monoclonal antibodies • Inflammation assays
Screening Services
Biomarker Analysis
Multiplex Kit Development
Capabilities
Facilities • Cell culture lab • Protein purification • Biomarker lab
Biologics Development
Services
Bio-Incubator ABI-LAB
Currently supports 16 companies
Consulting
Biologics Support • Bench-scale production • Pilot scale-up • Purification • Basic CMC, stability • Formulation • In-Silico
Partners • In-vivo services (oncology & NASH) • CLIA Certification • GLP
Extended Capabilities
• Production of recombinant proteins, enzymes and monoclonal antibodies • Optimization of growth conditions (media optimization and serum-free adaptation) • Supply any mammalian cell lines before and after cytokines stimulation • Customized services (> 10 human primary cells and > 400 mammalian cell lines are
currently available) • 2D and 3D capabilities • Irradiation experiments (combination therapy)
Protein Purification Services • Development of scalable, well understood, and reproducible purification processes • LC capability (Ion Exchange, HIC, Affinity, Metal, HA, SEC) • HPLC (Preparative and Analytical methods development) • Protein formulation and stability studies
Cell Culture Services (Mammalian & Insect Cells)
SBH Sciences has Produced and Commercialized 78 Cytokines and other Biologics
38 Recombinant proteins and 40 monoclonal antibodies
TGF-Beta (TGF-b2)
Interleukins (IL-12, IL-23)
Growth Factors (HGF)
Activin-A
GDF-15/MIC-1
Bone Morphogenic Proteins (BMP-2, BMP-7)
Soluble receptors (s-IL-6R) IGF-BPs (IGF-BP-6) Interferon (IFN-b)
Enzymes (8 Glycosyltransferase)
CD22 TNF Receptor (HVEM-Fc)
Anti-Galectin Anti-TNFa Anti-VEGF
All products are > 95% pure, tag-free, and carrier-protein free
Oncology and inflammation are the therapeutic areas where SBH Sciences is best positioned to assist you. • 300 cell-based assays to measure cytokine activity
(cytokine-induced proliferation, cytokine-induced killing, cytokine release assays and cytokine neutralization).
• Screening of therapeutic antibodies for specific activity (includes receptor binding assays , CDCC, ADCC and ADCP assays).
• 350 different human cancer cell lines to facilitate in-vitro lead drug optimization (cytotoxicity, invasion, and migration assays).
• Cell-based disease models for compound selection (inflammation / fibrosis – PBMC, THP-1, RAW 264.7, BEAS-2B and immortalized liver cell line).
Cell-Based Assay Capabilities
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Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) Promega Kit (G7010 ; 12.8-Fold Effector-to-Target)
Using SK-BR-3 Cells
Non Drug Herceptin - Drug
R&D Systems : Measured by its ability to induce hemoglobin expression in K562 human chronic myelogenous leukemia cells. Schwall, R.H. et al. (1991) Method Enzymol. 198:340. The ED50 for this effect is typically 2-10 ng/mL.
R&D Systems : Measured in a cell proliferation assay using BaF3 mouse pro-B cells transfected with mouse Flt-3. No ED50.
Existing Platforms to Assist with Biomarker Analysis AlphaScreen and AlphaLISA Simple Plex: ProteinSimple ELLA ELISA [Freedom EVO; TECAN] Flow Cytometry HTRF / TR-FRET Luminex 200 [Multiplex] Automated Western Blot [PeggySue / Wes] Analytical HPLC RT-PCR Chemical analyzer, VITROS 350
•SBH offers 10 platforms that have been utilized to analyze thousands of clinical samples (> 150 biomarkers). •First CRO to offer automated simple western blot services on “PeggySue” and “WES”.
•First CRO to offer Simple Plex assays on “ELLA”.
•SBH Diagnostics, our strategic partner, is a contract research organization providing analysis under Clinical Laboratory Improvement Amendments [CLIA] certifications and GLP.
Comprehensive Biomarker Analysis Services
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VEGF-165 (ng/ml) [log scale]
Development of Receptor Binding Assay for VEGF-165 Coating : VEGF-R1
Detection: Polyclonal anti-VEGF
Lot release based on active VEGF
Final Pool "UK" Day 39 (2/16/10)
Day 41 (2/16/10) Day 42 (2/16/10)
2D Western for Biomarker Discovery Utilizing Protein Simple’s “PeggySue” and “WES” -automated Western Blotting systems, SBH can rapidly analyze multiple samples for a specific biomarker
PeggySue: For characterization of expressed proteins in a biologic sample.
Comprehensive Pathway Analysis (Companion Biomarkers)
Pathways
MAP Kinases
Apoptosis
NFkB
Cell Cycle
Stress Response
JAK/STAT
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Cancer Cell Cytotoxicity (72 hours)
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350 human cancer cells are ready for immediate studies
Integrated in vivo and in vitro Services
Streamlined data transfer into animal models Efficacy studies ; PK/PD modeling
Standard to advanced modeling, including primary patient tumors Shorter development time and enhanced project success!
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8 2 1 3 4 7 Spheroid outgrowth over 8 days (boxes = 250 um) 1 represents initial spheroid plated
GBM spheroid 3D culture system with U87MG Glioblastoma cell line The radial spread in two
dimensions is reminiscent of the natural disease. Not shown here is the invasion down into the substrate as well.
Untreated GBM
Integrated in-vitro and in-vivo Services
Inflammation and Liver Fibrosis In-Vitro Services: In-Vivo Services: - TLR-4 - Fatty Liver (NAFLD) - TLR-7 / TLR-8 - NASH - iNOS - Fibrosis - M1 / M2 - Diet-Induced-Obesity - T-Cell Activation - Immuno-oncology
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WES Analysis [Protein Simple]
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Development of In-Vitro Inflammation Model using Human PBMC Evaluation of potential Drug in the presence of LPS
OD from ELISA measurement of h-TNFa
100% Neutralization Drug
January 27, 2014 Galectin Therapeutics and SBH
Sciences, Announce the Formation of Galectin Sciences, LLC,
a Collaborative Venture to Research and Develop Galectin Inhibitors
for Oral Administration
4 Patents have been submitted so far
Clinical Product Development - Case Study: human IL-12
a Novel Radiation Medical Countermeasure
• Proprietary human IL-12 production process was developed by SBH Sciences
• COA established for commercial release to the R&D market • Neumedicines, Inc. (CA) licensed the technology from SBH Sciences • In 2008, both companies collaborated to secure a Biomedical Advanced
Research and Development Authority (BARDA) contract to develop IL-12 for Acute Radiation Syndrome
• In 2009, SBH Sciences optimized the process, scale-up, and transferred the technology to a GMP manufacturing
• 2011 – Submission of IND and First-In-Human for Toxicity studies
SBH Sciences is an innovative biotechnology company and pre-clinical contract research organization which has been in operation for 22 years, providing over 200 companies with quality products and services.
SBH Sciences supported and guided 3 companies through all stages of drug development, bringing 7 NCE’s to clinical trials. One NDA was submitted (08/2018) and was approved by the FDA on 07/2019 [Xpovio (selinexor)].
Significant Impact
President & CSO
Regulation – QA / QC
Operations & Safety Manager
Office Manager and Treasurer
Director of Business
Development Website & IT
President & CSO
Cell Culture
Supervisor
Associate Scientist
Associate Scientist
Protein Purification
Supervisor
Associate Scientist
Biomarker
Supervisor
Senior Scientist
Associate Scientist
Associate Scientist
Bioassay
Supervisor
Associate Scientist
Associate Scientist
Discovery
Supervisor
Associate Scientist
Cell Therapy
Scientist
Ex-Vivo
Scientist
Scientist
Raphael Nir, Ph.D. President and CSO Tel: 508-650-6218
E-mail: [email protected] www.sbhsciences.com
Discovery Research Products & Services