Search results for "quality by design"
Article
Designing a 1.5 L Bench-Scale Model of a Perfusion Process
Establishing an appropriate model allows for higher throughput during simultaneous operation and monitoring of several cultures at different process conditions. In this article, we discus…
Article
Regulatory Challenges in the QbD Paradigm
Implementation of quality by design (QbD) in this environment has further contributed to the need to clarify what information needs to be included in a regulatory filing and how it should be presented…
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Determining Criticality–Process Parameters and Quality Attributes Part III: Process Control Strategies—Criticality throughout the Lifecycle
The author applies the continuum of criticality to develop the process control strategy and move through Stages 2 and 3 of the new process validation lifecycle.
With the most recent FDA …
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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Determining Criticality, Part Two: DoE and Data-Driven Criticality
A practical roadmap in three parts that applies scientific knowledge, risk analysis, experimental data, and process monitoring throughout the three phases of the process validation lifecycle.
T…
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State of Quality and Compliance in the Biopharmaceutical Industry
Among these initiatives are the Pharmaceutical cGMPs for the 21st Century, process analytical technology (PAT), quality by design (QbD), and harmonization of international standards and guidelines.
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QbD and PAT in Upstream and Downstream Processing
To gain perspective on the implementation of quality by design (QbD) and process analytical technology (PAT) in biopharmaceutical processing, BioPharm International spoke with Clinton Weber, as…
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Operational Excellence: More Than Just Process Improvement
By embracing efficiency and quality, biopharmaceutical organizations can work better and achieve better work.
Life-sciences companies face more pressure than ever to reduce costs and increase eff…
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Strategizing for Rapid Changeovers in Biologics Manufacturing
Other important facility design aspects for rapid changeover, according to Machulski, include: quality by design, design for manufacturability principles (i.e., lean, single-minute exchange of dies [S…
Article
The Evolving Role of Starting Materials in Cell and Gene Therapy
The Evolving Role of Starting Materials in Cell and Gene Therapy
Accelerated approval pathways and growing demand for cell and gene therapies are putting pressure on providers of cellular starting m…