November 1-5, 2015
Introduction: Advances in pharmaceutical manufacturing technology in the last decade provide new opportunities to reinvigorate and improve the quality of pharmaceutical manufacturing. One of those technologies is Continuous Processing, which offers a wide range of advantages. Traditionally, most focus has centred on the cost advantages while the industry has held back on more broadly implementing Continuous Process. One reason for this reluctance concerns the viewpoint on the technology from the authorities, particularly FDA and EMA.
This presentation will discuss the results from a survey of industry peers performed by BioPlan Associates for NNE Pharmaplan. The focus of the survey is to provide an expansive understanding of contributing factors to the relatively slow adaptation of Continuous Processing in the Biopharmaceutical industry. Additionally, the FDA’s point of view will be discussed as well as key quality advantages of the technology, which will be illustrated by examples. Moreover, the presentation will offer guidance for a structured and risk-based approach to successfully support the implementation of Continuous Processing
Morten Munk, "What is holding the industry back from implementing CBP (Continuous Bioprocessing) more broadly?" in "Integrated Continuous Biomanufacturing II", Chetan Goudar, Amgen Inc. Suzanne Farid, University College London Christopher Hwang, Genzyme-Sanofi Karol Lacki, Novo Nordisk Eds, ECI Symposium Series, (2015). https://dc.engconfintl.org/biomanufact_ii/69