Shortening the Distance from Research to Clinical Production

来源 :2008中国深圳蛋白质和多肽科学大会 | 被引量 : 0次 | 上传用户:hjlcd
下载到本地 , 更方便阅读
声明 : 本文档内容版权归属内容提供方 , 如果您对本文有版权争议 , 可与客服联系进行内容授权或下架
论文部分内容阅读
  Chromatography is the standard technology for purification of protein-based drugs.Instrumental to good process economy at manufacturing scale is the re-use of resins.However,clinical material is commonly only produced once and resins are then discarded.We will present the use ofpre-packed,pre-qualified and sanitized columns packed with standard chromatography media.This would allow the elimination of packing,santization and cleaning studies while maintaining the possibility to use the fully scalable resin technology for clinical manufacturing.In this study we have developed a three chromatography step mAb downstream process in lab scale and transferred it to pilot scale using the pre-packed,qualified and sanitized columns.
其他文献
The biological risks associated to the administration of viral vectors for gene therapy have restricted the further development of viral vectors and seriously challenged their incorporation to clinica
会议
In recent years many proteins produced in large quantities by recombinant DNA techniques have become important new drugs.However,protein drugs possess several shortcomings,including susceptibility to
会议
Amongst todays most relevant challenges in the immunodiagnostic field are the reduction of interassay variances and of assay interference as well as improved internal and external quality control.All
会议
High throughput cloning and expression of large sets of genomic ORFs has become a preferred industrial strategy for genome-wide searches of new vaccine candidates.For invasive infections in particular
会议
The over-expression of saccharides such as Globo-H,LewisY and Tn antigen is a common feature of oncogenic transformed cells.Endeavors to exploit this aberrant glycosylation for cancer vaccine developm
会议
The initiation of a cell-mediated immune response requires the binding of antigenic peptides to a host major histocompatibility complex (MHC) molecule.When this complex is successful,it will activate
会议
Over the last a few years,proteomics using tools such as LC-MS has identified huge numbers of potential biomarkers for various human diseases.It is of urgent to generate antibodies to those potential
会议
Recombinant protein therapeutics are routinely produced in mammalian host cell lines.The need for rapid entry of new molecular entities into clinical development requires rapid process development usi
会议
By immunizing ground-state peptides or proteins,we can produce "super catalytic antibodies (Antigenase)" possessing serine protease-like characteristics.The unique feature of Antigenase is their abili
会议
Multiple analytical technologies were employed to analyze various variants and/or impurities ofmonoclonal antibodies.Charge variants such as sialated species,deamidated species and species with un-pro
会议