The First Biopharmaceutical Characterization Laboratory in ASEAN
Advancing Science Through Strategic Collaboration
The biopharmaceutical industry has seen rapid growth in the past few years, which has only intensified with the COVID-19 pandemic. In response to the rising demand for biopharmaceutical drugs, Biopharmaceutical Characterization Laboratory (BPCL) plays a pivotal role in ensuring the safety and efficacy of vaccines, pharmaceuticals, biologics, or biosimilars. With their skilled expertise, BPCL provides comprehensive services from research and product development to characterization, quality control testing, and clinical trial development.
All of the methods in BPCL are specifically developed or adapted to meet the product requirements and international standards. Please contact us below if you are interested to engage BPCL one-stop services for biopharmaceutical and drug development research, including:
- Proteins Characterization
- Viral Characterization
- DNA/RNA Characterization
- Microbial & Cell Culture Characterization
Service Capabilities
BPCL provides One-Stop Services such as Protein Characterization, Microbial & Cell Culture Characterization, Viral Characterization, DNA and RNA Characterization, including analytical chemistry, cell culture and microbiology, DNA & RNA analysis, stability studies, bioanalysis, virology, and protein & peptide analysis in compliance with ISO/IEC 17025, GLP and/or GMP, where appropriate.
Shimadzu offers state-of-art equipment and advanced technologies to support BPCL’s service capabilities. This includes LCMS-Triple Quadrupole, LCMS-QTOF, HPLC, UV-Vis Spectrometer, and MALDI-TOF-MS* etc., which deliver reliable and robust results with a short turnaround time.
*This product may not be available in your country. Please contact your local Shimadzu representative for more information.
Protein Characterization
Primary Structure
- Amino Acid Analysis
- Charge Variant Analysis
- Post Translational Modification
- N- and O-Linked Glycosylation
- Oxidation, Deamidation, Glycation
- Peptide Mapping
- Intact Molecular Weight
- N-Terminal sequencing
- Molecular weight determination
Secondary & Tertiary Structure
- Disulfide Bridge Mapping
- C-terminal sequencing
- Circular Dichroism
- Thermal Stability
Isoform & Purity Analysis
- Capillary Electrophoresis
- SDS PAGE, and IEF
- Impurity and Degradant Characterization
- HPLC Methods such as RP HPLC, IEX
Aggregation, Particle size & High-order Structures
- Purity
- Size Exclusion
- Analytical Ultracentrifugation
- SDS-PAGE
- CE-SDS
Analysis of Impurities and Contaminations
- Host cell protein assays
- Host cell DNA assays
- Process related impurity testing (antibiotic etc.)
- Virus Contamination
Others
- ELISA & Enzymatic / Colorimetric Assays
- Cell-based assays
- Total protein
- Water Determination
- Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) (expansion plan)
- Complement Dependent Cytotoxicity (CDC) (expansion plan)
Microbial & Cell Culture Characterization
Microbial Characterization
- Identity & Purity
- Viability
- DNA Sequencing
Cell Culture Characterization
- Sterility (Direct Inoculation)
- Identity & Purity
- Viability
- DNA Sequencing (Targeted Gene)
DNA & RNA Characterization
Squencing
- Whole Genome
- Microbial
- Viral
- Targeted
- Bacteria
- Viral
- Cell Culture
Others
- DNA/RNA Quantitative by Fluorometer
- DNA Mapping by Agarose Gel Electrophoresis
Viral Characterization
Viral Characterization
- Kinetic & Affinity by Surface Plasmon Resonance (SPR)
- DNA Sequencing
- Glycoprotein Analysis by MALDI-TOF
- AUC
Others
- Viral Quantitative Affinity by Surface Plasmon Resonance (SPR)
