인문학
사회과학
자연과학
공학
의약학
농수해양학
예술체육학
복합학
지원사업
학술연구/단체지원/교육 등 연구자 활동을 지속하도록 DBpia가 지원하고 있어요.
커뮤니티
연구자들이 자신의 연구와 전문성을 널리 알리고, 새로운 협력의 기회를 만들 수 있는 네트워킹 공간이에요.
초록·키워드
Many protein-based vaccines comprise viral surface proteins which are chosen for their ability to stimulate the immune system. These vaccine molecules are often heavily glycosylated, and glycosylation plays critical roles in the immunological and stability properties of vaccines. The structural characterization and product quality attribute monitoring of such complex vaccine therapeutics during process development and manufacturing is very challenging. High throughput monitoring of multiple molecular attributes, particularly glycosylation, of recombinant glycoprotein subunit vaccines are needed to support entire vaccine production processes. Multi-attribute monitoring (MAM) technology involves assessing multiple critical molecular attributes of molecules in one set of analyses in an automated fashion, for product quality attribute requirements. MAM is still in the early development stages and is currently applied to therapeutics with very low levels of glycosylation such as monoclonal antibodies. MAM on glycoproteins with a higher number of glycosylation sites with high glycan heterogeneity such as subunit vaccine molecules is challenging as each glycan site and glycan modification exponentially increases data processing complexity. We developed a MAM workflow to perform detailed structural characterization of subunit protein vaccines, monitoring critical parameters such as intact mass, sequence identity, protein clipping, glycosylation, other post-translational modifications, and host cell proteins (HCP). By using a combination of software tools and product process monitoring strategy, we performed data processing at multiple steps and identified key attributes for each vaccine candidate under the development pipeline. Further, a high-throughput critical attribute monitoring MAM workflow was developed to support the influenza and HIV vaccine development processes including cell line selection, cell clone selection, cell culture optimization, stability study evaluation and final vaccine product characterization.
인공지능 문자 인식 모델을 통해 추출된 텍스트로, 일부 오타나 오류가 포함될 수 있으나 지속적으로 개선 중입니다.
오류를 발견하셨다면 해당 부분을 드래그한 후 ' 를 통해 신고해주세요.
오류를 발견하셨다면 해당 부분을 드래그한 후 ' 를 통해 신고해주세요.