"Analyzing Monoclonal Antibody (mAb) products can be challenging due to the size and complexity of the protein intermediates and final Drug Product. These challenges can be even more daunting when trying to manage multiple CDMOs and CROs depending on their areas of expertise. Boston Analytical has rolled out a comprehensive analytical solution that provides regulatory-tested methodologies for every aspect of characterizing the purity, potency, and identity of mAbs in a one-stop shop format. Boston Analytical strives to provide characterization services that are tailored to your protein. Phase-appropriate qualification strategies are employed and non cGMP in-process/scale-up optimization services offerings are available.
BA Sciences can support monoclonal and polyclonal antibodies as well as antibody fragments and bispecifics. In addition, our expertise in small molecule analysis supports antibody-drug conjugate evaluations. See how we can help!"
BA Sciences is a cGMP-compliant, FDA/DEA registered, ISO/IEC-17025:2017 accredited analytical laboratory with locations in Salem, NH and Morrisville, NC, providing testing services to Pharmaceutical, Biopharmaceutical & Medical Device companies worldwide. Our focus is to provide undeniably accurate data ensuring patient/consumer safety through critical sampling, staffing, and testing services.
