Search results for " UV calibration"
Article
Understanding Validation and Technical Transfer, Part 2
Understanding Validation and Technical Transfer, Part 2
A validation plan developed to support a process unrelated to bio-pharmaceutical manufacture is applied to biopharmaceutical processes and sys…
Article
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
Supplier-Change Management for Drug-Product Manufacturers
Pharmaceutical change management processes extend to the materials and services employed to manufacture and test drug products, necessitating the need for an effective supplier-initiated change …
Article
Report from the 12th Plasma Product Biotechnology Forum
Since the first meeting in 1999, the PPB forum has established itself as the key international forum for the plasma manufacturing industry – read our report for the highlights of the 2022 conference…
Article
FAQ: Scale-up and scale-down with mechanistic modeling
A mechanistic model can simplify your process development projects. The model eases scale-up and scale-down between lab scale and production scale. To apply model-based scale-up and scale-down…
Article
Insider Recommendations for Getting Started with Mechanistic Modeling of Chromatography
Insider Recommendations for Getting Started with Mechanistic Modeling of Chromatography
Click here to view more Industry Leader Q&As >>
Gunnar Malmquist, Senior Principal Scie…
Article
The Importance of Partnering for Bioanalytical Studies
The Importance of Partnering for Bioanalytical Studies
Yakobchuk Olena/Stock.Adobe.com
Bioanalytical studies are an important aspect of biologic drug development that may necessitate…
Article
Monitoring and Control of Inline Dilution Processes
Buffer management has received less attention in process intensification despite the high costs and labor-, space-, time-, and material-intensive nature of this common downstream activity.
By…
Article
Moving PAT from Concept to Reality
The learning curve for process analytical technology has slowed widespread adoption.
By Cynthia A. Challener
alexlmx a- Stock.Adobe.com
Process analytical technology (P…
Article
Leveraging Computational Models of Glycosylation for Biopharma QA
Close collaboration between academic and industrial groups is vital to ensuring glycosylation models are fit for deployment.
By Ioscani Jiménez del Val
Good Studio/S…