Crisino Rebecca M, Geist Brian, Li Jian
Janssen, R&D, LLC, A Division of Johnson & Johnson R&D, LLC, 145 King of Prussia Road, Radnor, PA 19087, USA.
Bioanalysis. 2012 Sep;4(17):2103-7. doi: 10.4155/bio.12.191.
The American Association of Pharmaceutical Scientists (AAPS) is an international forum for the exchange of knowledge among scientists to enhance their contributions to drug development. The annual National Biotechnology Conference, organized by the AAPS on 21-23 May 2012 in San Diego, CA, USA, brings together experts from various disciplines representing private industry, academia and governing institutions dedicated toward advancing the scientific and technological progress related to discovery, development and manufacture of medical biotechnology products. Over 300 scientific poster presentations and approximately 50 oral presentation and discussion sessions examined a breadth of topics pertaining to biotechnology drug development, such as the advancement of vaccines and biosimilars, emerging and innovative technologies, nonclinical and clinical bioanalysis, and regulatory updates. This conference report highlights the existing challenges with ligand-binding assays, emerging challenges, innovative integration of various technology platforms and applicable regulatory considerations as they relate to immunogenicity and pharmacokinetic bioanalytical assessments.
美国药物科学家协会（AAPS）是一个供科学家交流知识的国际论坛，旨在增强他们对药物研发的贡献。由AAPS于2012年5月21日至23日在美国加利福尼亚州圣地亚哥举办的年度全国生物技术会议，汇聚了来自代表私营企业、学术界和管理机构的各个学科的专家，致力于推动与医疗生物技术产品的发现、开发和制造相关的科技进步。300多个科学海报展示以及约50场口头报告和讨论会议探讨了与生物技术药物开发相关的广泛主题，如疫苗和生物类似药的进展、新兴和创新技术、非临床和临床生物分析以及法规更新。本会议报告重点介绍了与免疫原性和药代动力学生物分析评估相关的配体结合测定的现有挑战、新出现的挑战、各种技术平台的创新整合以及适用的法规考量。
