Process analytical technology (PAT) needs and applications in the bioprocess industry: Review

Markku Känsäkoski, Marika Kurkinen, Niklas von Weymarn, Pentti Niemelä, Peter Neubauer, Esko Juuso, Tero Eerikäinen, Seppo Turunen, Sirkka Aho, Pirkko Suhonen

Research output: Book/ReportReport

Abstract

Process analytical technologies have been applied to manufacturing processes (pulp and paper, chemical and petroleum) for decades. Recently, the US Food and Drug Administration (FDA) has, however, re-defined the phrase and implemented it into an initiative focusing on improving several aspects of the pharmaceutical industry. The European Agency for the Evaluation of Medicinal Products (EMEA), has also been active and formed a PAT team in 2003. The PAT initiative was initially intended for traditional pharmaceutical manufacturers, but the FDA's PAT guidance now clearly states that it applies to all manufacturers of human and veterinary drug products, as well as biologics regulated by the FDA's Center for Drug Evaluation and Research (CDER) and the Center for Veterinary Medicine (CVM). Basically, PAT involves a fundamental shift from testing the quality of the finished drug product, to building quality into products by testing at several intermediate steps. It specifically requires that quantifiable, causal, and predictive relationships be established amongst raw materials, the manufacturing process, and final product quality. It is believed that PAT may not bring dramatic changes overnight, but years from now, it may be seen as an initiative that helped foster a period of innovation, efficiency, and expansion for the biopharmaceutical industry. In this report, the impact and potential effects of PAT on the biotechnological production of pharmaceuticals is assessed. Hence, we define BioPAT as process analytical technologies applied throughout development, scale-up and commercial scale bioprocess-based production of drug substances. In this report, we will focus on what PAT means in practice for the biotechnological manufacture of pharmaceuticals. Besides a regulatory examination, the monitoring methods and technologies available are thoroughly surveyed. These facts are then reflected against the needs for monitoring in bioprocess-based pharmaceutical production.
Original languageEnglish
Place of PublicationEspoo
PublisherVTT Technical Research Centre of Finland
Number of pages100
ISBN (Electronic)951-38-6612-2
Publication statusPublished - 2006
MoE publication typeNot Eligible

Publication series

SeriesVTT Working Papers
Number60

Keywords

  • process industry
  • process analytical technologies
  • applications
  • bioprocess industry
  • pharmaceutical industry
  • drugs
  • regulations
  • analytical measurements
  • biomanufacturing

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    Känsäkoski, M., Kurkinen, M., von Weymarn, N., Niemelä, P., Neubauer, P., Juuso, E., Eerikäinen, T., Turunen, S., Aho, S., & Suhonen, P. (2006). Process analytical technology (PAT) needs and applications in the bioprocess industry: Review. VTT Technical Research Centre of Finland. VTT Working Papers, No. 60 http://www.vtt.fi/inf/pdf/workingpapers/2006/W60.pdf