Results 201 to 210 of about 4,485 (257)

BCMA-CD19 armored compound CAR T cells in systemic lupus erythematosus: extended follow-up of a phase 1 clinical trial. [PDF]

open access: yesJ Hematol Oncol
Hong M   +20 more
europepmc   +1 more source

Development of a Chemometric Platform for Mid-Infrared Fermentation Monitoring

open access: yes
Torres-Acosta MA   +5 more
europepmc   +1 more source

Process analytical technology (PAT) for biopharmaceutical products

Analytical and Bioanalytical Chemistry, 2010
The "Pharmaceutical Current Good Manufacturing Practices (CGMPs) for the 21st Century--A Risk Based Approach" initiative announced by the FDA in August 2002 to improve and modernize pharmaceutical manufacturing facilitated adoption of process analytical technology (PAT) by the pharmaceutical industry.
Anurag Rathore
exaly   +3 more sources

Chemometrics in bioprocess engineering: process analytical technology (PAT) applications

Chemometrics and Intelligent Laboratory Systems, 2004
Abstract The production process of an active pharmaceutical ingredient (API) by fermentation in an industrial environment was analysed using process analytical technologies.The Food and Drug Administration's (FDA) process analytical technology (PAT) initiative is intended to be a collaborative effort with industry to promote the integration of new ...
João A Lopes, JOSÉ Cardoso Menezes
exaly   +2 more sources

CHEMOMETRIC PROCESS ANALYTICAL TECHNOLOGY (PAT) APPLICATIONS IN BIOPROCESS ENGINEERING

IFAC Postprint Volumes IPPV / International Federation of Automatic Control, 2005
Abstract The production process of an active pharmaceutical ingredient (API) by fermentation in an industrial environment was analysed using process analytical technologies. The Food and Drug Administration's (FDA) process analytical technology (PAT) initiative is intended to be a collaborative effort with industry to promote the integration of new ...
João A Lopes, JOSÉ Cardoso Menezes
exaly   +2 more sources

Process Analytical Technologies (PAT) in freeze-drying of parenteral products

Pharmaceutical Development and Technology, 2009
Quality by Design (QbD), aims at assuring quality by proper design and control, utilizing appropriate Process Analytical Technologies (PAT) to monitor critical process parameters during processing to ensure that the product meets the desired quality attributes.
Sajal Manubhai, Patel, Michael, Pikal
openaire   +2 more sources

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