TY - BOOK
T1 - Process analytical technology (PAT) needs and applications in the bioprocess industry
T2 - Review
AU - Känsäkoski, Markku
AU - Kurkinen, Marika
AU - von Weymarn, Niklas
AU - Niemelä, Pentti
AU - Neubauer, Peter
AU - Juuso, Esko
AU - Eerikäinen, Tero
AU - Turunen, Seppo
AU - Aho, Sirkka
AU - Suhonen, Pirkko
PY - 2006
Y1 - 2006
N2 - 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.
AB - 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.
KW - process industry
KW - process analytical technologies
KW - applications
KW - bioprocess industry
KW - pharmaceutical industry
KW - drugs
KW - regulations
KW - analytical measurements
KW - biomanufacturing
M3 - Report
T3 - VTT Working Papers
BT - Process analytical technology (PAT) needs and applications in the bioprocess industry
PB - VTT Technical Research Centre of Finland
CY - Espoo
ER -