Bioanalytical Method Development
In general, the development of bioanalytical methods is important for the discovery of biotherapeutic macromolecules. Our analytical capabilities span analytical development and testing as well as quality control (QC) testing. Our analytical development and QC teams have extensive experience in the field of analytical development. BOC Sciences has introduced the latest instrumentation to provide a wide range of analytical services to our customers. In addition, our experienced team has the ability to develop assays for most therapeutic proteins, including but not limited to monoclonal antibodies, recombinant proteins, antibody-drug conjugates, fusion proteins, and peptides. Our analytical team also supports regulatory submissions by providing the required analytical method validation, testing and documentation.
Figure 1. Current state of bioanalytical chromatography in clinical analysis. (Kočová Vlčková, H.; Pilařová, V.; et al. 2018)
Our Services
To make it easier and better for researchers, BOC Sciences provides bioanalytical method 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.
Quality Controls
BOC Sciences' analytical quality control team uses validated and effective strategies for environmental monitoring and drug testing as well as GMP stability testing in compliance with ICH standards. Our scientists have established procedures to evaluate all GMP areas and processes to ensure continuous control. We are equipped with an independent safety testing laboratory to provide our customers with additional assurance that their products are safe and have been manufactured in accordance with testing requirements
Biologics Characterization
BOC Sciences offers comprehensive biologics characterization services within a state-of-the-art facility. An experienced team of experts in a variety of disciplines can rapidly develop, validate and implement bioanalytical assays to meet regulatory expectations for the detection of large molecule drugs. In addition, our professional team has extensive project experience supporting all phases of drug development
Bioactivity Testing
The biological activity of a biologic product reflects the ability or capacity of the product to achieve a defined biological effect. Generally, bioactivity testing involves in vitro testing and/or in vivo testing. BOC Sciences has developed mature bioassays for testing different types of bioactive proteins, and our bioanalytical method development team works with clients to select and optimize assays to provide raw data, as well as a professionally formatted report and a detailed summary of the bioassay protocol used
Safety Assessment
BOC Sciences is committed to providing a customized, end-to-end strategy solution for your drug development program, from discovery to market authorization. Our unique preclinical, clinical and bioanalytical platforms enable you to rapidly develop large-molecule drugs. We are equipped with a complete safety assessment facility to evaluate the safety of new drug candidates from toxicology, safety pharmacology, and genetic toxicology
DMPK Service
Aiming to ensure the safety and efficacy of biologics, pharmacologists often apply very sensitive ligand binding assays to support PK studies. At BOC Sciences, the wide range of assays is particularly beneficial for PK analysis at high doses or during toxicity assessment. We have introduced bioassays that cover the entire range of drug concentrations to allow for PK analysis throughout a drug development program.
Figure 2. Cross-Validation of ADA Assays. (Loo, L.; Harris, S.; 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 bioanalytical method development at competitive prices for global customers. Personalized and customized services of bioanalytical method 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!
References
- Kočová Vlčková, H.; Pilařová, V. et al. Current state of bioanalytical chromatography in clinical analysis. Analyst. 2018. 143(6): 1305-1325.
- Loo, L.; Harris, S. et al. 2021 White Paper on Recent Issues in Bioanalysis: TAb/NAb, Viral Vector CDx, Shedding Assays; CRISPR/Cas9 & CAR-T Immunogenicity; PCR & Vaccine Assay Performance; ADA Assay Comparability & Cut Point Appropriateness (Part 3-Recommendations on Gene Therapy, Cell Therapy, Vaccine Assays; Immunogenicity of Biotherapeutics and Novel Modalities; Integrated Summary of Immunogenicity Harmonization). Bioanalysis. 2022.
