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Growth and Advancements in Fill/Finish
Employing novel technologies and more patient-centric approaches
Delving into Biopharmaceutical Development and Manufacturing
Quality Considerations in Changing Excipient Providers
December 03, 2023
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.
Drug shortages across Europe are being exacerbated by increased demand, struggling supply chains, and manufacturer suspensions.
What does the 2024 VPAS mean for pharma?