Biologics Drug Discovery
In contrast to small molecule drugs that are chemically synthesized and have a known structure, biologics are large molecules with complex, heterogeneous structures that are often unstable and sensitive to external conditions. Due to their high degree of complexity, the development of biologics drugs requires a comprehensive set of quantitative, accurate and precise bioanalytical tools.
We provide a broad portfolio of functional bioassays and protein characterization tools to accelerate your biologics drug discovery and development. Explore these pages to learn about Promega products, quality standards, scientific and manufacturing support available for biologics drug discovery. We are here to help you in your drug discovery pursuits.
Explore Biologics Products and Services
State-of-the-art reporter bioassays and cell health assays for bioactivity and potency testing.
Protein Characterization Tools
Advanced analytical tools for antibody purification and mass spec analysis.
Rigorous quality standards for product development, including bioassay pre-qualification according to ICH guidelines.
QC Lot Release
Documentation, scientific support and bioassay qualification services for biologics manufacturing and QC.
Introduction to Biologics Drug Discovery
Biological therapeutics (biologics) are revolutionizing the treatment of cancer and immune inflammatory disease states. Initially, biologic drugs were limited to simple peptide molecules (e.g., insulin). However, in recent years, with the progression of innovative technological approaches, biologics comprised of monoclonal antibodies, fusion proteins, vaccines, cell and gene therapies have been created and deployed in the treatment of disease. To standardize practices in the development of these therapies, authorities from regulatory agencies and the pharmaceutical industry have established organizations, such as the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and the U.S. Pharmacopeia (USP), that issue guidelines to help ensure the production of safe, effective and high-quality medicines. These policies are not only important for novel innovator biologics, but also for the generation of biosimilar molecules. Biosimilars are biologics that are highly similar to and possess no clinically meaningful difference from a previously approved reference product.
Because of the inherent complexity and variability of these therapeutics, robust characterization tools are essential throughout the drug discovery and development process to ensure on target mechanism of action, drug potency and biomanufacturing process consistency. As an example, cell based functional bioassays enable quantitative interrogation and validation of a biologic molecule’s target specificity (e.g., immune checkpoint receptor) or mechanistic endpoint (e.g. ADCC). In addition, reagents that facilitate streamlined antibody purification and site-specific enzymes for mass spectroscopy-based analysis are crucial tools in biologics development workflows.