Biologics Characterization
Structure, activity and potency of biologic drugs are critical quality attributes that need to be well characterized and monitored in the drug discovery process to reduce risk in drug development. At BOC Sciences, decades of scientific expertise and advanced technologies enable us to meet your development and manufacturing needs, and we offer a full suite of chemical-based analytical testing services to ensure the properties of your compounds and products are well characterized. Our biologics characterization solutions support the workflow from drug discovery to downstream characterization of biologics. BOC Sciences has the experienced staff and modern equipment to work on any kind of biologic drug product, including proteins, peptides, monoclonal antibodies (mAbs), bispecific antibodies, and antibody-drug conjugates (ADCs). Our team of scientists have employed a rational and scientifically driven approach based on the physicochemical and biophysical behavior of compounds to develop bioanalytical strategies and rapidly evaluate relevant properties. Formulations are designed, characterized and evaluated for their expected performance based on the intended route of administration and indication.
Figure 1. Assay flows for all stages of biopharmaceutical development. (Raper, V. 2018)
Our Services
To make it easier and better for researchers, BOC Sciences provides biologics characterization service in a competitive fashion. We have provided a more efficient way to increase the number of new drugs, greatly shorten the R&D cycle, and reduce the development costs.
Biophysical Analysis and Characterization
Our expert teams provide biophysical characterisation of biologics laboratory services to support protein development by applying UV, CD, NMR, FTIR, fluorescence, SEC-MALS, AUC, DLS and DSC
Biopharmaceutical Physiochemical Characterization
BOC Sciences provides comprehensive comprehensive biopharmaceutical bioanalysis, analysis, characterization, and potency services to address the challenges of identity, purity, quality, safety and efficacy for proteins, antibodies, vaccines, antibody drug conjugates, peptides, cytokines, oligonucleotides and biosimilars
Bioanalytical Expertise
- Binding / Potency
Enzyme Activity, ELISA, Cell-Bassed Assay, UV Protein Concentration
- Identification
Western Blot, SDS-PAGE, Sequencing by LC-MS/MS, Accurate Mass, Unknown Peak ID
- Characterization
Peptide Map, AAA, Oligosaccharide Analysis, Glycosylation Profile, Extinction Coefficient, Gel Permeability
- Purity
Chromatogprahic - RP-HPLC, IEX-HPLC, SEC Electrophoretic - SDS-PAGE, CE-SDS, IEF, cIEF
- Safety
Residual Host Cell Protein, Endotoxin (LAL), Bioburden, Sterility, Sub-visible Particulates (HIAC and MFI)
Figure 2. Overall diagram for the identification strategy of an ideal biocatalyst. (Guazzaroni, M.; Silva-Rocha, R.; et al. 2015)
State-of-the-art Equipment
- Liquid chromatography with tandem mass spectrometry (LC-MS/MS)
- Inductively coupled plasma tandem mass spectrometry (ICP-MS/MS)
- Gas chromatography with tandem mass spectrometry (GC-MS/MS)
- High-resolution mass spectrometry
- Liquid chromatography with ion-trap mass spectrometry (LC-TRAP-MS)
- Liquid chromatography with time-of-flight mass spectrometry (LC-TOF-MS)
- Good Laboratory Practice (GLP)-and Good Clinical Practice (GCP)-accredited laboratories
Why choose BOC Sciences?
Our dedicated CMC team has provided tailored solutions to our clients from engagement to launch. With many years of industry experience, we provide clients with the following:
- Comprehensive, integrated CMC services with a flexible service model that grows with your programs
- Knowledgeable industry experts who deliver scalable, actionable insights
- World-class facilities and equipment that remain at the forefront of the global pharmaceutical research, analytical and development standards
- Our comprehensive services support products at every stage of the product lifecycle, from early-stage discovery to full commercial cGMP manufacture
- A focus on risk management that is designed to ensure completion of your technical goals
BOC Sciences provides professional, rapid and high-quality services of biologics characterization at competitive prices for global customers. Personalized and customized services of biologics characterization can satisfy any innovative scientific study demands. Our clients have direct access to our staff and prompt feedback to their inquiries. If you are interested in our services, please contact us immediately!
References
- Raper, V. in the mAb race, don’t stumble at characterization. GEN. 2018.
- Guazzaroni, M.; Silva-Rocha, R.; et al. Synthetic biology approaches to improve biocatalyst identification in metagenomic library screening. Microbial Biotechnology. 2015. 8(1): 52-56.
