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Biologic Drug
Commercialization
US and European regulations for biosimilars differ, impacting commercialization and affordability of biotherapeutics.
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The highly customized nature of cell and gene therapy production means that manufacturing innovations for one therapy may not be easily transferable to others.
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Parental Drug Manufacturing
Empty and prefilled syringes must pass a range of quality control tests.
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A one-size-fits-all approach to monitoring practices and results is never appropriate, given the diversity of practice within the pharmaceutical industry.
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Corning Valor® Glass
• Aggressive freeze-thaw testing verifies superior performance for new vial option
• New vial option 40X less likely to break during low temperature processing
• New vial technology may reduce manufacturing costs for low temperature processes
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Solid-Dose Drug Development
Flexibility and well considered manufacturing approaches could help tablet manufacturers face the increasing pressure resulting from the shifting bio/pharma development landscape.
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Market demand and regulatory guidance continues to promote improved medication design.
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Laboratory testing found that a novel approach reduced the time required for sample preparation from hours to minutes. This article summarizes test methods and results.
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Modified-release oral dosage forms can offer benefits to both formulation scientists and patients.
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A Strategic Approach to Purchasing Process and Packaging Equipment
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Compliance Questions,
Answered
Cultural and language discrepancies during an audit can be resolved using what many call a "playbook."
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A good working relationship between sponsor and contractor will become invaluable when an OOS occurs.
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When it comes to audits, it is important to understand both sides of a non-compliance finding.
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A robust customer complaint handling system is an integral part of a quality management system.
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Events
September 10–11, 2019
September 16–18, 2019
September 18–20, 2019
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