Analytical Development
Analytical method development is widely adopted as a means of ensuring that the methods used to measure the purity and potency of small molecule APIs are of high quality and suitable for the ensuing cGMP synthesis. BOC Sciences is committed to providing expert advice to our customers to ensure that all analytical needs of their projects are met. We take full account of cGMP manufacturing compliance . At BOC Sciences, our team fully understands the importance of analytical support and our dedicated analytical science and quality control experts can provide a full range of analytical method development, validation and testing services to support the entire pre-clinical phase. In addition, our dedicated stability management team extends our services throughout the product lifecycle.
Figure 1. AQbD tools and life cycle. (Raman, N.; et al. 2015)
Our Services
To make it easier and better for researchers, BOC Sciences provides analytical development 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.
BOC Sciences' analytical development group offers guidance on preclinical development of API manufacturing. The quality of our analytical development is supported by the experience and our highly skilled scientists in drug substance development activities, state-of-the-art instrumentation, close cross-functional interaction, adherence to standard operating procedures (SOPs), extensive regulatory training, and quality assurance oversight. All standard tests and protocols are performed in accordance with ICH and USP guidelines.
Chemical and formulation development support
- Analytical methods development and validation/cross-validation
- In-process control method development
- Starting material and raw material testing
- Impurity profiling
- Impurity isolations and characterization
- Degradation product characterization
- Compatibility testing
- Accelerated, intermediate and long-term stability and forced degradation studies
- Dissolution testing
Figure 2. API synthetic development and AQbD approach. (Raman, N.; et al. 2015)
Release testing
- Methods development and validation
- Preclinical prototype evaluation including biorelevant characterization of your solid oral dosage forms
- Purity and assay (wt/wt)
- Total related substances (impurities)
- Dissolution and content uniformity
- Residual solvent quantification
- Moisture content assessment
- Counter-ion determination
- Compendia testing for elemental impurities, ROI, and LOD
- Physical property measurement
- Impurity and degradation product structural identification
- Microbial limit tests (Ch.P&USP)
- Documentation and Issuance of COA's
State-of-the-art instrumentation
- Chromatography: UPLC, HPLC, Nano HPLC, GC, IC, SEC, SFC
- Mass spectrometry: QTOF, MALDI-TOF, LC-Orbitrap, LC-MS, LC/MS/MS, 2D LC-MS, GC-MS
- Polarimeter
- Identification: NMR, HRMS, FT-IR
- General test ing: KF, UV-Vis,
- Solid state characterizat ion: XRPD, DVS, DSC, TGA with MS interface, PSD, nano- particle size analyzer, polarized light microscope, SEM, surface area analyzer
- Elemental analyzer: ICP-OES, ICP-MS
- USP dissolution apparatus type I and II
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 development at competitive prices for global customers. Personalized and customized services of analytical development 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
- Raman, N.; et al. Analytical Quality by Design Approach to Test Method Development and Validation in Drug Substance Manufacturing. Journal of Chemistry. 2015. 2015: 1-8.
