BCMA-CD19 armored compound CAR T cells in systemic lupus erythematosus: extended follow-up of a phase 1 clinical trial. [PDF]
Hong M +20 more
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Real-time monitoring of selective laser sintering 3D printing process for lamivudine content quantification in the printlets: a modern solution to a modern problem. [PDF]
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An Application for Through-Vial Impedance Spectroscopy (TVIS) in the Qualification of the Pirani-Gauge Assessment of the Ice Sublimation Endpoint. [PDF]
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Patulin Biodegradation by Rhodosporidiobolus ruineniae and Meyerozyma guilliermondii Isolated From Fruits. [PDF]
Ji Y, Hong SY, Qu J, Chu Q, Ma S, Om AS.
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Development of a Chemometric Platform for Mid-Infrared Fermentation Monitoring
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Process analytical technology (PAT) for biopharmaceutical products
Analytical and Bioanalytical Chemistry, 2010The "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
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Chemometrics in bioprocess engineering: process analytical technology (PAT) applications
Chemometrics and Intelligent Laboratory Systems, 2004Abstract 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
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CHEMOMETRIC PROCESS ANALYTICAL TECHNOLOGY (PAT) APPLICATIONS IN BIOPROCESS ENGINEERING
IFAC Postprint Volumes IPPV / International Federation of Automatic Control, 2005Abstract 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
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Process Analytical Technologies (PAT) in freeze-drying of parenteral products
Pharmaceutical Development and Technology, 2009Quality 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
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