Bioactivity Testing
Bioactivity is a key quality attribute, and potency testing is the quantitative measurement of the biological activity of a biologic drug, making bioactivity testing critical to ensure the quality, safety and efficacy of biopharmaceutical products. The bioactivity of each batch of a biologic drug must be confirmed before use, and the most commonly applied method for confirming bioreactivity is potency assay. Pharmacologists conduct a series of bioactivity and potency tests to measure the ability of a drug to elicit a specific response at a given dose in a relevant biological system. A range of assays include animal-based assays (measuring biological responses), ligand and receptor binding assays (measuring drug-target interactions), cell culture-based assays have been developed. Our expert teams offer a full range of bioactivity and potency testing services for a variety of biologics, including in vivo and in vitro bioassays, to rank potential therapeutic candidates.
Our bioactivity testing should be able to differentiate product batches based on the following criteria:
- The amount of active ingredient is sufficient to cause a biological effect
- Sub-potent batches can be identified (including storage under accelerated conditions and forced degradation studies)
- Ensure the consistency of drug product
Figure 1. Structures and mechanisms of action of anti-TNF biologics. (Igon-Branc, S.; Barli, A., et al. 2019)
Our Services
To make it easier and better for researchers, BOC Sciences provides bioactivity testing 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.
In Vitro Bioassay Services
- Binding assays
We use immunoassays (e.g. ELISA) to measure the interaction of a drug with its target and determine binding activity
- Enzyme activity assays
BOC Sciences supports spectrophotometric, fluorometric, calorimetric, chemiluminescence and light scattering assays to determine enzyme activity. We are equipped with either enzyme-linked immunosorbent assay or flow cytometry assay formats
- Cellular Assays
Our teams develop custom cell-based assays based on customer needs to help determine which type of cell-based assay is best for your product
Cell-based assay services
- Cell proliferation assays
For products to treat neurodegenerative diseases, heart disease or wound healing, we recommend cellular quantitative proliferation assays (e.g. MTT assays) to test their efficacy
- Cell death assays
For biologics that target and kill certain cells, our experts use assays that measure cell death to test their potency
- Reporter gene assays
Our experienced experts are able to create engineered cell lines to evaluate the effectiveness of various biologic products by using reporter genes to show biological activity
- Cell signaling assays
Biopharmaceuticals often produce specific therapeutic effects by activating signaling cascades. We develop potency assays for your products that show increases or decreases of certain signaling molecules such as cAMP
- Cell types available
Primary cells, immortalized/transformed cell lines, commercially available immortalized/transformed cell lines, whole blood, isolated human blood cells (PBMC, lymphocytes, monocytes, etc.) and customized transfected cell lines
Figure 2. Bioassays of anti-TNF biologics. (Neil, W.; Charter, A. et al. 2016)
Bioassay development services
- Method development
- Method validation: We can validate your in vitro bioassay following ICH requirements: accuracy, precision, linearity, range, specificity, LOD/LOQ, and robustness
- Method optimization: Our knowledge and experience are available to improve your bioassays and find the best way to optimize your methods
- Method transfer: Our teams can transfer the strategy to your lab so you can perform the routine batch release testing at another location
- Phase-appropriate method validation: We provide appropriate phase method development and validation strategies for potency assays
- Routine batch release testing: BOC Sciences is equipped with a cGMP compliant lab that can perform a variety of different batch release tests on different products
- Bioactivity testing within stability studies
- Accelerated stress studies
- Comparability testing between innovator and biosimilar biological products
Figure 3. Linearity and interlot reproducibility studies. (Neil, W.; Charter, A. et al. 2016)
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 bioactivity testing at competitive prices for global customers. Personalized and customized services of bioactivity testing 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
- Igon-Branc, S.; Barli, A. et al. In vitro Cell-Based Assays for Potency Testing of Anti-TNF-α Biological Drugs. IntechOpen. 2019.
- Neil, W.; Charter, A. et al. Accelerating Biologic and Biosimilar Drug DevelopmentReady-to-Use, Cell-Based Assays for Potency and Lot-Release Testing. BioProcess International. 2016.
