Progressing Biotherapeutics to Clinic Faster
Biological activity of a biotherapeutic is a Critical Quality Attribute (CQA), which needs to be accurately measured by an appropriate potency bioassay during all phases of the product lifecycle, from development to post-marketing approval. Regulatory agencies, such as the US FDA and EMA, have frequently noted that implementing a validated bioassay for potency testing in lot release is one of the most challenging and time-consuming activities, and should be initiated earlier in the biologic development program. Key aspects of the assay design depend on the drug’s mechanism of action (MOA), and should address phase-specific requirements. The inherent variability of biological drugs, as well as biological test systems such as cells, create significant challenges for establishing a robust bioassay in a quality controlled (QC) environment, and in ensuring long-term assay reproducibility. Hence, the design and implementation of a bioassay can be complex, costly, and take several months to years.
Ensuring Development Time and Program Cost Savings
The growing urgency of delivering these life-saving therapies to patients faster is also driving the need for more efficient and fast approaches to design, validate, and implement mechanistically relevant analytical methods. Ready-to-use, qualified, cell-based potency assays reduce overall assay development time and program costs. However, there are very few vendors that offer such ready-to-use solutions. Eurofins DiscoverX provides the most comprehensive menu of over 40 ready-to-use MOA-based bioassays that have been developed using stable cell lines and qualified with marketed innovator drugs, reference standards, or ligands. Each bioassay is based on the native biology of the drug target receptor and provides a receptor-proximal readout — in contrast to the distal readouts of phenotypic and reporter-gene assays — that is highly specific to that drug. The assay development strategy ensures that each bioassay meets the QC requirements for linearity, accuracy, precision, and robustness, and uses a simple, no-wash protocol that delivers results in 24–48 hours. These bioassays are available as complete kits, including cryopreserved cells and reagents required to run the assay, which facilitates faster and easy method transfer and implementation at the GLP testing sites. These bioassays can also be easily optimized for the detection of neutralizing antibodies in clinical samples.
Eurofins DiscoverX bioassays are successfully implemented in lot release testing of several marketed drugs both in US and EU. With the industry’s largest off-the-shelf menu of qualified bioassays and assay development expertise, Eurofins delivers products and support to help take clients’ drug to market, with confidence.
For more information on Eurofins DiscoverX bioassays, visit: www.discoverx.com/bioassay