As the biologics industry continues to expand, especially where biosimilars are concerned, there is an increasing need for the performance of bioactivity testing. Bioassays determine the activity of biological products and are required for regulatory submissions. These assays help ensure the quality, safety, and efficacy of biological products and can be used at all points in the development process including early phase in vitro biocomparability, stability testing, and lot release packages.
Due to the increasing needs of pharmaceutical and biotech companies, we are expanding our lab capacities for bioactivity testing at our Erkrath, Germany site. The new laboratory in Germany will offer 450 m² of lab space designed to meet the special requirements of bioactivity testing. The new state-of-the-art labs are planned as functional units to improve workflow and allow for faster processing times.
In the new laboratory, Charles River will continue to offer the development, transfer, and optimization of bioassay methods including support for lot release, stability testing, accelerated stress condition testing, and comparability testing. Readouts include absorbance, fluorescence, time-resolved fluorescence, luminescence, and flow cytometry. The assessment of monoclonal antibodies, hormones, antiviral compounds, and growth factors will all be supported in the facility. Biosimilarity testing for BLA applications for biosimilars has always been a focus for Charles River and we will continue to do this along with expanding our biosimilar capabilities. Charles River already has developed bioassays for many biosimilars and has broad experience with testing innovator products including ADCs and bispecific and truncated mAbs. This combination makes us uniquely qualified to provide expert options and support for the analysis of biosimilars.
We expect the new laboratory to be operational by the end of Q3 2017. If you have questions about the facility or would like to inquire about bioassays for your particular product, please contact us at [email protected].