BioPharmaDev
BioPharmaDev, Inc. is an FDA-registered CRO company providing analytical chemistry testing, formulation, and CMC product development services for pharmaceutical, biotech, medical device, and dietary supplement industries. They focus on high-quality, compliant, and timely services to support clinical studies and registration needs, with a team of seasoned professionals dedicated to drug development and research.
Industries
Nr. of Employees
small (1-50)
BioPharmaDev
370 W. Grand Blvd, Suite 110, Corona, CA 92882
Services
Analytical method development and validation, analytical testing, forced-degradation studies, stability studies, raw material qualification, formulation development, specification development, and drug compatibility testing to support drug product development.
Testing and characterization of polymer materials (composition, molecular weight distribution, reverse engineering), vendor qualification assistance, raw material selection support, and extractables/leachables analysis for packaging and medical device materials.
Initial method development and mid-scale purification for large biologics (proteins, antibodies, DNA, polypeptides) and small molecules; purification and isolation of phytochemical/marker compounds.
Analytical method development and validation for dietary supplements, purification/isolation of marker compounds, stability study design and testing, and raw material identification and qualification for botanical products.
Gap analysis for analytical and quality systems, optimization or establishment of cGMP systems, planning and instruction for late-stage drug product development (CMC), assistance with FDA submissions and support for Pre-Approval Inspections (PAI).
Analytical method development and validation, analytical testing, forced-degradation studies, stability studies, raw material qualification, formulation development, specification development, and drug compatibility testing to support drug product development.
Testing and characterization of polymer materials (composition, molecular weight distribution, reverse engineering), vendor qualification assistance, raw material selection support, and extractables/leachables analysis for packaging and medical device materials.
Initial method development and mid-scale purification for large biologics (proteins, antibodies, DNA, polypeptides) and small molecules; purification and isolation of phytochemical/marker compounds.
Analytical method development and validation for dietary supplements, purification/isolation of marker compounds, stability study design and testing, and raw material identification and qualification for botanical products.
Gap analysis for analytical and quality systems, optimization or establishment of cGMP systems, planning and instruction for late-stage drug product development (CMC), assistance with FDA submissions and support for Pre-Approval Inspections (PAI).
Expertise Areas
- Analytical chemistry and method validation
- CMC and formulation development
- cGMP quality systems and inspection readiness
- Chromatography and separation sciences
Key Technologies
- High-performance liquid chromatography (HPLC)
- Forced-degradation studies
- Stability testing
- Extractables and leachables analysis
News & Updates
Received a letter from the FDA indicating the August 2018 inspection was closed with a 'No Action Indicated' classification.
Successfully completed and passed an FDA cGMP inspection with no deficiencies on August 23, 2018.
Dr. Yang co-authored an editorial article in the Journal of Molecular and Applied Bioanalysis on July 21, 2017.
Dr. Yan-Bo Yang presented on Analytical Characterization of Traditional Herbal Medicines at a conference in Irvine, CA, on December 19-20, 2016.
AOAC INTERNATIONAL published ALACC Guidelines in August 2016, with Dr. Yang as a key contributing leader.
Dr. Yang received an Official Methods Board Award for Achievement in Technical and Scientific Excellence from AOAC on July 26, 2015.
Received a letter from the FDA indicating the August 2018 inspection was closed with a 'No Action Indicated' classification.
Successfully completed and passed an FDA cGMP inspection with no deficiencies on August 23, 2018.
Dr. Yang co-authored an editorial article in the Journal of Molecular and Applied Bioanalysis on July 21, 2017.
Dr. Yan-Bo Yang presented on Analytical Characterization of Traditional Herbal Medicines at a conference in Irvine, CA, on December 19-20, 2016.
AOAC INTERNATIONAL published ALACC Guidelines in August 2016, with Dr. Yang as a key contributing leader.
Dr. Yang received an Official Methods Board Award for Achievement in Technical and Scientific Excellence from AOAC on July 26, 2015.