Materials Map

Discover the materials research landscape. Find experts, partners, networks.

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The Materials Map is an open tool for improving networking and interdisciplinary exchange within materials research. It enables cross-database search for cooperation and network partners and discovering of the research landscape.

The dashboard provides detailed information about the selected scientist, e.g. publications. The dashboard can be filtered and shows the relationship to co-authors in different diagrams. In addition, a link is provided to find contact information.

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Materials Map under construction

The Materials Map is still under development. In its current state, it is only based on one single data source and, thus, incomplete and contains duplicates. We are working on incorporating new open data sources like ORCID to improve the quality and the timeliness of our data. We will update Materials Map as soon as possible and kindly ask for your patience.

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in Cooperation with on an Cooperation-Score of 37%

Topics

Publications (1/1 displayed)

  • 2006Process analytical technology (PAT) needs and applications in the bioprocess industrycitations

Places of action

Chart of shared publication
Känsäkoski, Markku
1 / 4 shared
Weymarn, Niklas Von
1 / 1 shared
Niemelä, Pentti
1 / 2 shared
Aho, Sirkka
1 / 1 shared
Kurkinen, Marika
1 / 3 shared
Suhonen, Pirkko
1 / 1 shared
Juuso, Esko
1 / 1 shared
Eerikäinen, Tero
1 / 1 shared
Turunen, Seppo
1 / 1 shared
Chart of publication period
2006

Co-Authors (by relevance)

  • Känsäkoski, Markku
  • Weymarn, Niklas Von
  • Niemelä, Pentti
  • Aho, Sirkka
  • Kurkinen, Marika
  • Suhonen, Pirkko
  • Juuso, Esko
  • Eerikäinen, Tero
  • Turunen, Seppo
OrganizationsLocationPeople

report

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

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

Process analytical technologies have been applied tomanufacturing processes (pulp and paper, chemical andpetroleum) for decades. Recently, the US Food and DrugAdministration (FDA) has, however, re-defined the phraseand implemented it into an initiative focusing onimproving several aspects of the pharmaceutical industry.The European Agency for the Evaluation of MedicinalProducts (EMEA), has also been active and formed a PATteam in 2003. The PAT initiative was initially intendedfor traditional pharmaceutical manufacturers, but theFDA's PAT guidance now clearly states that it applies toall manufacturers of human and veterinary drug products,as well as biologics regulated by the FDA's Center forDrug Evaluation and Research (CDER) and the Center forVeterinary Medicine (CVM). Basically, PAT involves afundamental shift from testing the quality of thefinished drug product, to building quality into productsby testing at several intermediate steps. It specificallyrequires that quantifiable, causal, and predictiverelationships be established amongst raw materials, themanufacturing process, and final product quality. It isbelieved that PAT may not bring dramatic changesovernight, but years from now, it may be seen as aninitiative that helped foster a period of innovation,efficiency, and expansion for the biopharmaceuticalindustry. In this report, the impact and potentialeffects of PAT on the biotechnological production ofpharmaceuticals is assessed. Hence, we define BioPAT asprocess analytical technologies applied throughoutdevelopment, scale-up and commercial scalebioprocess-based production of drug substances. In thisreport, we will focus on what PAT means in practice forthe biotechnological manufacture of pharmaceuticals.Besides a regulatory examination, the monitoring methodsand technologies available are thoroughly surveyed. Thesefacts are then reflected against the needs for monitoringin bioprocess-based pharmaceutical production.

Topics
  • impedance spectroscopy