PerkinElmer Inc. has launched a range of assay kits utilizing AlphaLISA technology to help improve the safety testing, manufacturing and quality control of biotherapeutic drugs.
Biotherapeutic drug development is a rapidly growing field due to the highly targeted and specific nature of these drugs, which are particularly beneficial for the treatment of patients with cancer, inflammatory disease and rare diseases. Biotherapeutics are naturally occurring molecules, such as antibodies, recombinant proteins and vaccines, and are recognized as an alternative to small-molecule approaches for drug development.
Regulatory requirements addressing potentially harmful side effects and undesirable contaminants that can lead to toxic reactions or adverse immune responses are more stringent for biotherapeutic drugs than for small molecule drugs. PerkinElmer carefully developed these new assays to meet these more stringent performance requirements relating to drug impurities and toxic effects.
The kits use PerkinElmer’s AlphaLISA technology to achieve higher quality results than the comparable ELISA (enzyme-linked immunosorbent assay) technology in half the time, helping to accelerating the drug discovery process. AlphaLISA technology also has a simple protocol with fewer assay steps compared to standard ELISA, resulting in better inter- and intra-assay precision, greatly improved coefficient of variations (CVs), and easier method transfer to downstream departments due to reduced variability.