Case study · Biochemical and Immunology Assays
In vitro immunogenicity assessment of new biologics (cytokine induction assay)
Published in Cancer Research, 2019, 79(6):1239- 1251.
Pharma / Biotech
IND-enabling studies for pharma and biotech teams
GLP and non-GLP toxicology, PK/ADME, and analytical and bioanalytical support, with study design built around what an IND or NDA submission needs.
Applications
Where we help
The Center For Biomedical Testing provides all the necessary services for new drug development and FDA submission.
- Nonclinical development
- GLP/
non-GLP toxicology - PK/
ADME - Analytical/
bioanalytical - IND/
NDA-enabling programs - Regulatory-focused study design
Services
Comprehensive Services in Preclinical Research
01
Analytical & Bioanalytical
Analytical and bioanalytical services for drug development.
02
Toxicology & Safety
GLP-compliant acute, subchronic, chronic, genotoxicity, ADME, PK, development and reproductive toxicity studies.
03
Efficacy & Disease Models
Many models to test diseases (including cancer, diabetes, infection, radiation, etc.) and safety and efficacy testing of new drugs.
04
Regulatory
Helping you navigate the regulatory approval process, from inception to IND and NDA submission.
Clients & case studies
“I have been extremely satisfied with CBT’s services, having been a client since 2013.”
Jonathan Sorger, PhD VP of Research, Intuitive Surgical “CBT has become a part of our team and our go-to preclinical and analytical CRO.”
Ilya Rachman, MD, PhD, MBA CEO, Immix Biopharma, Inc “Collaborating with CBT translates into the shortest and least expensive way to achieve drug development goals without cutting any corners.”
S. Rakhilin, PhD 15+ year pharmaceutical industry veteran “I was extremely impressed and pleased with CBT’s superb quality of work, excellent professionalism, and high level of dedication of every person in their staff.”
Zoya Gluzman-Poltorak, PhD, MBA VP of Therapeutics Development, ASC Therapeutics
Case study · Analytical and Bioanalytical Support
Development and Evaluation (Quantitation) of the Anti-Drug Antibodies (ADA) Assay in the Dog Plasma
The purpose of this study was to develop and qualify a method for detection of anti-drug antibodies (ADA) against therapeutic peptide with nanocarrier in dog plasma…
Team
Who leads it
Jaseem Anwer, PhD
Scientific Director
Leads analytical, bio-analytical, safety pharmacology, and pharmacokinetics studies.
Full bio →
Matthew Lindeblad, B.S.
Director of Toxicology & Process Validation
Study Director on more than 40 GLP and non-GLP studies.
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James H. Fischer, Pharm.D., FCCP
Director of Pharmacokinetics
He is the author of over 50 peer-reviewed research publications.
Full bio →Richard W. Shubart, M.S., MBA
Quality Assurance
Over 35 years of Quality Assurance experience in the Pharmaceutical Industry.
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