Search results for " process" in Articles / App Notes
Article
Determining Criticality-Process Parameters and Quality Attributes Part I: Criticality as a Continuum
As the pharmaceutical industry tries to embrace the methodologies of quality by design (QbD) provided by the FDA’s process validation (PV) guidance (1) and International Conference on Harmonization (I…
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Regulatory Challenges in the QbD Paradigm
Even for those drugs that are manufactured in the US, a significant portion of the raw materials and process intermediates is imported from manufacturers outside the US. It's no wonder that "Supply Ch…
Article
Digitalization: The Route to Biopharma 4.0
The ultimate objective is to make an automated smart factory, wherein the process operations and control decisions are executed without human supervision. Such a setup offers multiple advantages, such…
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Determining Criticality, Part Two: DoE and Data-Driven Criticality
The most recent FDA (1) and International Conference on Harmonization (ICH) (2-4) guidance documents advocate a new paradigm of process validation based on process understanding and control of paramet…
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Quality by design for biotechnology products—part 1
…tes and setting specifications, followed by the development of the design space and establishing the process control strategy; to later stages, including incorporating QbD into a regulatory filing an…
Article
Moving PAT from Concept to Reality
In-line sensors are placed in a process vessel or process stream to conduct the analysis in-situ. On-line sensors are connected to process side streams and perform periodic automatic sampling, returni…
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Improving PAT for Biologics
Dec 01, 2014
By Cynthia Challener, PhD
BioPharm International
A key component of the quality-by-design (QbD) approach to pharmaceutical manufacturing is the implementation of process ana…
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Making the Move to Continuous Chromatography
Switching from batch to continuous allows for improved resin capacity utilization through continuous loading (overloading, in fact) of the column or membrane for increased process efficiency. It is pa…
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The Development and Application of a Monoclonal Antibody Purification Platform
The platform was developed to maximize the efficiency of the purification process and product purity while minimizing the development time for early-phase therapeutic antibodies. The success of this p…
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Setting Up Bioprocessing Systems for Digital Transformation
By Feliza Mirasol
The advancement of digitalization technologies is transforming manufacturing processes and operations in the biopharmaceutical industry. Bioprocessing is no exception, as the ind…