In Vitro Potency Assays
In vitro potency assays plays an important role in ensuring the continued quality, safety and efficacy of biopharmaceutical products. Each batch of a biologic drug must be confirmed for bioactivity before it can be used by patients, and pharmacologists conduct this strategy to determine whether a drug candidate is worthy of further study in human clinical trials. The most commonly applied method for confirming bioreactivity is a cell-based potency assay, and a variety of biologics including therapeutic antibodies, recombinant proteins and gene therapy products need to be confirmed accurately. BOC Sciences specializes in developing multiple in vitro potency assays to ensure optimization for specific drugs and to find the best solution for our customers.
Application of In Vitro Potency Assays
- Reveal whether a compound acts on a biological target
- Reacts to its potency
- Whether the biopharmaceutical has any side effects and potentially harmful toxic effects
Figure 1. From functional assays to potency assays. (Vivian, V, T.; Nguyen, K. et al. 2020)
Our Services
To make it easier and better for researchers, BOC Sciences provides in vitro potency assays 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' in vitro biology team continues to develop, optimize, validate and run a large number of potency assays. We have screened millions of compounds and generated a wealth of high-quality data for our customers.
- Our state-of-the-art technologies include FLIPR, HTRF, AlphaScreen, radioactivity detection and analysis, FACS, LC/MS, and nanoliter liquid handling systems
- BOC Sciences' in vitro biology team works closely with our chemistry, biology, pharmacology, DMPK and toxicology departments in collaborative project teams to discover and advance compounds in hit rate, lead optimization and early drug development programs
Traditional Readout and Assay Technology
With a diversity of biochemical, biophysical and cellular assay technologies, our scientists will combine multiple readouts to reveal the true mechanism of action of compounds to help select, optimize and validate the best chemical, biological or cellular leads
- Classical receptor pharmacology and biochemistry: BOC Sciences supports radioactive binding assays as well as enzymatic expertise to assess the binding kinetics or reversibility of compounds
- Cell-based readout: We have introduced a series of fast, highly specific, and accurate quantitative readout tools. Our teams apply recombinant systems, native cells or tissue-based models to immunoassay formats (MSD, Singulex, FRET), flow cytometry and high-content imaging recombinant systems
- Electrophysiology: High-throughput automated screening, rapid perfusion studies, and slice electrophysiology are available
- Label-free methods: We can define and optimize binding patterns through a combination of LC/MS NMR, ITC, DSF, SPR and MST methods
- Phenotypic screening: BOC Sciences' phenotypic imaging platform supports multiple image analysis tools
Product-specific Cell-based Bioassays
- Cytokines/antiviral compounds
BOC Sciences can perform regulated bioassays for various cytokine products such as IFN-α, IFN-β
- Growth factors and hormones
We use classical proliferation assays to measure the potency of human growth factors such as EPO, GMCSF and G-CSF
- Monoclonal antibodies
Antibody-dependent cytotoxicity (ADCC) is measured by using surrogate reporter cell lines as effector cell replacements, and antibody-dependent cell phagocytosis (ADCP) is measured by luminescence-based reporter bioassays or by flow cytometry. Complement-dependent cytotoxicity (CDC) is measured by luminescence-based methods or by flow cytometry using live/dead discriminatory dyes. Apoptosis/programmed cell death (PCD) is addressed by flow cytometry-based assays or monitored by reporter-based assays
Figure 2. An in vitro potency assay for extracellular vesicles. (Karin, P.; Nina, K. et al. 2017)
Our In Vitro Potency Assays Capabilities
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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 in vitro potency assays at competitive prices for global customers. Personalized and customized services of in vitro potency assays 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
- Vivian, V, T.; Nguyen, K. et al. Functional assays to assess the therapeutic potential of extracellular vesicles. Journal of Extracellular Vesicles. 2020. 10(1).
- Karin, P.; Nina, K. et al. An In Vitro Potency Assay for Monitoring the Immunomodulatory Potential of Stromal Cell-Derived Extracellular Vesicles. International Journal of Molecular Sciences. 2017. 18(7): 1413.
