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Growth and Advancements in Fill/Finish
Leveraging automation advancements can help improve efficiency in aseptic processing.
Changes and Trends in the Outsourcing Landscape
Quality Considerations in Changing Excipient Providers
December 04, 2023
Novartis has issued a nationwide voluntary recall of two lots of Sandimmune Oral Solution (cyclosporine oral solution, USP), 100 mg/mL because of crystallization issues.
December 03, 2023
The bio/pharmaceutical industry is struggling with the challenge of staffing and training.
Matching excipients to API properties is essential.
Collaboration is a key component to achieving long-term success with genetic medicines.
Digital transformation allows for smarter and connected biomanufacturing operations.
December 02, 2023
Sufficient stability studies show a drug product meets regulatory requirements, therefore ensuring the drug reaches the patients who rely on it.
By taking a strategic and evidence-based approach, companies can leverage the insights gained from stability studies to establish robust labeling.
Eradicating paper-based workflows and standalone solutions operating in isolation provides a good starting point to update quality management processes.
The rising complexity of clinical research protocols has necessarily expanded the CRO landscape.
The ICH Q9 revision clarifies QRM implementation for the pharmaceutical industry and expands descriptions of methodology, formality, and risk-based decision making to provide the industry with a solid base from which to build their own QRM programs.