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Analytical methods and tools play a pivotal role in cleaning validation.
Sufficient stability studies show a drug product meets regulatory requirements, therefore ensuring the drug reaches the patients who rely on it.
One of the main purposes of stability testing is to establish shelf life for these drug producBy taking a strategic and evidence-based approach, companies can leverage the insights gained from stability studies to establish robust labeling.
March 07, 2024
FDA has published final guidance documents regarding validation and development of analytical procedures.
March 02, 2024
There is a great need for sensitive, precise, and easily accessible analytical detection techniques for protein sequencing.
February 29, 2024
This discussion explores how the management and analysis of vast data generated by advanced analytical technologies are revolutionizing the drug discovery and development process within the biopharma industry.
February 06, 2024
The addition of another amino acid recognizer as well as improvements in surface chemistry, reagents, and software expand the proteome coverage of Quantum-Si’s Platinum sequencing platform.
February 03, 2024
The emergence of mRNA vaccines and cell and gene therapies has pushed innovation in analytical methods.
February 02, 2024
Effective analytics will eliminate failures, deviations, and non-conformances.
Strategizing a PK/PD study approach in early phase development facilitates a successful clinical progression.
Under a new collaboration, Lonza and Oxford Nanopore aim to commercialize a CGMP-validated test for advanced analysis of mRNA products.
January 04, 2024
Roche will acquire select parts of the LumiraDx group related to that company’s point-of-care technology, which integrates multiple tests on a single instrument.
January 02, 2024