Analytical Testing for Drug Substances and Drug Products
Knowledge of properties of the drug substances and drug products plays an important role in determining the optimal formulation method for preclinical and Phase I studies. Analytical testing is a critical tool to make you have a complete understanding of product quality. BOC Sciences is committed to learning as much as possible about drug substance in the early stages. With our experience in multiple chemical classes, our experts have developed advanced analytical methods for different drug substances and drug products. Our experienced scientists have the ability to add tremendous value to your pre-formulation phase program while reducing time, which makes us the best partner for your pre-formulation work.
Our Services
To make it easier and better for researchers, BOC Sciences provides analytical testing for drug substances and drug products 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. The BOC Sciences team is committed to providing professional and timely analytical chemistry support. We can offer high quality, affordable pharmacopeial testing based on customer-specified characterization to support raw materials, in-process analysis, and finished product release testing. Our state-of-the-art chemistry labs have the instrumentation needed to perform various testings.
Service Areas
- Excipient compatibility testing
- In process control and release testing in comply with GMP requirement
- Stability testing
- Solubility
- Forced degradation study for the detection of impurities or degradation products
- Particle size study
- Excipient compatibility to support your prototype selection
- Fast content uniformity
- Blend uniformity
- Discriminative dissolution
Chromatographic Techniques
BOC Sciences develops robust and accurate chromatographic methods suitable for pre-clinical stage, and optimizes these methods to support different development activities. We select appropriate chromatographic mode based on the characteristics of the molecule and the traits to be evaluated.
- We support reversed-phase, ion-pairing, ion-exchange, size-exclusion, and hydrophobic interaction chromatography
- In addition to UV detection analysis, we can apply other detection methods such as evaporative light scattering, refractive index, fluorescence, mass spectrometry
Spectroscopic Techniques
- X-ray Powder Diffraction (XRPD): Characterize the crystalline properties of molecules
- Differential Scanning Calorimetry (DSC): Characterize salts, polycrystals and hydrates to assess the thermal properties of drug substances and drug products and formulations to guide the formulation development
- Analysis of moisture content by Karl Fischer titration (KF): In the development of lyophilized drug products, KF is used to determine the moisture content of lyophilized product samples. These data are important for the development of lyophilization processes as well as release and stability testing
- Thermogravimetric Analysis (TGA): TGA can also be used to evaluate lyophilized drug products to provide crucial information for process development and optimization
- Microscopy
a. Bright field optical microscopy provides qualitative assessment of particle size and morphology
b. Cross-polarization microscopy assesses the presence of crystalline components in materials by monitoring birefringence
Figure 1. Schematic illustrating the steps of a typical sample processing method for N-glycan analyses of monoclonal antibodies (mAbs) and IgGs. (Taron, C.; Duke, R. 2015)
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 analytical testing for drug substances and drug products at competitive prices for global customers. Personalized and customized services of analytical testing for drug substances and drug products 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!
Reference
- Taron, C.; Duke, R. N-Glycan Composition Profiling for Quality Testing of Biotherapeutics. BioPharm International. 2015. 28(12).
