Earticle

초록

영어

This paper will consider some of the key issues relating to the manufacturing and quality of a biosimilar drug substance that arise during assessment for marketing approval in European Union (EU). Details of the manufacture of the drug substance, starting with thawing of the WBC represent an important component of the submission. The applicant needs to be aware that this represents a commitment and should allow some flexibility in this description. In-Process Controls need to be based on process development experience and defined before validation. Furthermore the action to be taken if a control parameter is out of specification is normally required. Control of starting materials need to be defined including source, history and generation of the cell substrate and the cell banking system.Before submission it is important that the entire process is fully validated and the reproducibility and robustness of the process demonstrated. The Committee on Health and Medicinal Products (CHMP) will be in interested in the development of the manufacturing process and the early studies that have shaped the current process. There is a need to particularly focus on earlier processes which were involved in generating batches used in the non-clinical and clinical program with robust comparability data included.Data on the quality and integrity of the protein forms another cornerstone of the submission and there is a need to apply state of the art methods in order to confirm the structure and understand the heterogeneity and impurity profile. These data form part of the justification of the specifications for release of the drug substance. Stability studies form another important aspect of the EU application requiring data from batches produced by the final production process. This presentation will cover the key Quality issues relating to the drug substance that EU regulators focus on in granting market authorisation approval.

저자

• Cecil NICK [ PAREXEL Consulting. ]

참고문헌

발행기관

간행물

표지보기 관심저널 등록

• 간행물명

  한국생물공학회 학술대회

• 간기

  반년간

• 수록기간

  1985~2013

• 십진분류

  KDC 476 DDC 576