Search results for " monitoring" in Articles / App Notes
Article
Nurturing Knowledge from Disparate Data Streams
“With TOF instruments it is possible to gather detailed spectra in just three minutes, so the technique can be useful for screening experiments or monitoring the progress of a synthetic reaction or ce…
Article
Using Multiple Techniques in Biosimilar Analysis
Application of multiple techniques at different conditions presents a more complete picture of a dynamic situation.
By Rebecca Strawn
Sergey/stock.adobe.com
Almost all drug product…
Article
Digital Technologies Aid Productivity and Growth
By applying remote monitoring solutions, advanced modeling, and optimization of manufacturing processes, digitalization can offer improved process reliability and product quality through the unlimited…
Article
Recent Advances in the Use of Exoglycosidases to Improve Structural Profiling of N-glycans from Biologic Drugs
Recent Advances in the Use of Exoglycosidases to Improve Structural Profiling of N-glycans from Biologic Drugs
Analytical exoglycosidases are transitioning from being largely academic tools to being s…
Article
FDA Seeks to Enhance Manufacturing of Cell and Gene Therapies
FDA Seeks to Enhance Manufacturing of Cell and Gene Therapies
More consistent and reliable production processes are critical for advancing innovative treatments.
By Jill Wechsler
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Article
Ensuring Viral Safety of Viral Vaccines and Vectors
A three-pronged approach—verifying the safety of raw materials, monitoring process intermediates for unintended viruses, and removing viral threats from products—can help prevent the administration of…
Article
A Look into the Future of Biopharmaceutical Quality
The industry seems to be moving toward a continuous monitoring where results regarding the quality of the product can be achieved in real-time. The current processes used to update procedures, systems…
Article
Understanding Validation and Technical Transfer, Part I
Although the LVP GMP regulations were never finalized and were ultimately withdrawn, they established formalized requirements for the validation and monitoring of critical processes such as sterilizat…
Article
Freedom to Roam During Protein Purification Runs
Have you ever felt tied to your ÄKTA system and itching to get out of the lab? Consider this scenario: You have started a run in the lab and want to get some work done in your office. You may …
Article
Transformative Medicines Challenge FDA and Manufacturers
FDA reports that some 40 companies are developing CAR-T technologies for multiple indications and that it is monitoring more than 600 active investigational new drug applications (INDs) related to gen…