Biopharmaceutical Physiochemical Characterization
Physicochemical properties of the drug provides critical assistance in the development of drug products in formulation design and process development. BOC Sciences has the capability to provide many biopharmaceutical characterization and analytical services. For example, pH-solubility curves, ionization and permeability are key parameters for assessing the properties of drug substances. In addition, our team is able to provide critical data of physicochemical properties for the development and manufacture of successful biologics development. BOC Sciences offers a full suite of state-of-the-art instrumentation and techniques for physiochemical characterization.
Figure 1. Engineering, activity and pharmacokinetic profiling of SYNB1618. (Simeonov, Anton. 2019)
Our Services
To make it easier and better for researchers, BOC Sciences provides biopharmaceutical physiochemical 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.
- Solubility Assessment
We evaluate the effect of pH and ionic strength on drug solubility to provide a basis for experimental design for formulation development and enable the development of highly concentrated formulations
- pH Stability Analysis
To understand how compounds behave in different pH environments, we plot pH stability curves to determine the pH of maximum stability and develop mechanism-based approaches to stabilize the molecules
- Thermal Stability
Exposure to different temperatures during storage and production presents a direct liability to the physical stability of proteins. To prevent material degradation of drug substances and instability caused by storage or processing conditions, we conduct thermal stability studies
- Stability to Shear
During sample preparation and production, drug substances are often subjected to a variety of mechanical stresses, which can cause conformational changes leading to loss of activity, as well as adsorption, aggregation and precipitation. BOC Sciences provides insight into which stress factors can lead to instability of biologics
- Potency and Biological Activity
We have extensive experience in method development, method transfer, and GMP-compliant bioassay projects, and our experts can perform routine potency measurements using methods such as cell migration, ligand binding, ELISA, cell signaling, cell proliferation and inhibition of proliferation, binding assays, or competition assays
- Determination of Physiochemical Properties of Proteins
In accordance with ICH guidelines, our team can perform physicochemical characterization of protein therapeutics or other biologics, including molecular weight, isomerization, electrophoresis, chromatography, and spectroscopy
- Comparability Studies
Our laboratories are equipped with a broad technical equipment and based on years of experience, our strategic approach to comparability projects allows us to provide highly relevant comparability study protocols including characterization of physicochemical properties, structure, conformation and potency for a wide range of biologics such as antibodies, oligonucleotides
- Biosimilar Testing Services
Biosimilar development is designed based on the comparability of the biosimilar to the originator drug, and we support preclinical and clinical trials through detailed analysis of physiochemical, structural and biological potency properties
- Process-related Impurity and Residue Analysis
Our process residue analysis team follows ICH guidelines and applies a range of highly specific and sensitive techniques to provide robust quantification of impurity and residue to support process validation, monitoring batch-to-batch variation to help you ensure that your product meets these regulatory limits for process residues
- Biologics GMP Release Testing
GMP batch or lot release testing services for biologic drug products are important to ensure quality control of proteins, monoclonal antibodies (mAbs) or biosimilars. BOC Sciences has applied a range of GMP release testings to address product purity, concentration, consistency, identity and biosafety issues
Figure 2. Purification and formulation modules. (Simeonov, Anton. 2019)
Analytical Methods
- Separation
Reversed Phase, IP-RP, HIC, HILIC, IEX and SEC, AF4-high molecular weight species
- Detection
UV/FLR/ELSD, RI/MALS, MS (Triple Quad and High Res)
- Capillary Electrophoresis
cIEF-isoelectric point and charge distribution, CE-SDS-chain integrity
- Mass Spectrometry Assessments
Intact, Reduced, Deglycosylated Mass Determination
Sequencing (Peptide Mapping, Oligonucleotides)
Disulfide Bonding/Structural Elucidation
Glycosylation (N- and O-linked)
Carbohydrate Analysis (Released Glycans, Monosaccharides, Sialic Acid)
Chemical & Post-Translational Modifications
Identification of Process Impurities/ Related Substances
Extractables & Leachables
HCP Identification
Bioanalytical Quantitation
Figure 3. Identification and structural characterization of pterin deaminase. (Raj Dhanapal, A.; Thandeeswaran, M. et al. 2022)
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 biopharmaceutical physiochemical characterization at competitive prices for global customers. Personalized and customized services of biopharmaceutical physiochemical 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
- Simeonov, Anton. Literature Review: Advanced Biologic Therapies and Advanced Biologics Manufacturing. GEN. 2019.
- Raj Dhanapal, A.; Thandeeswaran, M. et al. Identification and structural prediction of the unrevealed amidohydrolase enzyme: Pterin deaminase from Agrobacterium tumefaciens LBA4404. Biotechnology and Applied Biochemistry. 2022.
