원문정보
초록
영어
Large and complex biomolecules are becoming increasingly important in new biotherapeutics. They include very large complex proteins, conjugates, immunoglobulins, pDNA, viruses, viral nanoparticles and virus-like-particles. These large biomolecules ranging from a few hundred to millions of kDa and up to hundreds of nanometers in size, pose great challenges not only in biomanufacturing but also in-process bioprocess monitoring and analysis of such biomolecules. Monolithic bioseparation media, in contrast to conventional particle-based media which is largely dependent on pore diffusion for mass transfer, consist of a single piece of highly porous polymer material with highly interconnected network of large channels (diameter > 1500nm), within which the biomolecules are instantly transported to the binding sites by convective flow, resulting in very efficient and fast mass transfer between the mobile and stationary phase. As a consequence, the separation of these large proteins, viruses, VLPs and pDNA can be achieved within seconds to a few minutes with very high resolution and binding capacity independent of flow rate. Even very short column just a few mm in height and 100ul in volume, provides extremely good separations in less than 10 minutes making it very suitable for analysis, in-process monitoring as well as process development of large and complex biomolecules