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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
May 02, 2023
Guidance for GMP manufacture of emerging therapies has evolved to accommodate innovation and the broader spectrum of products in development, but greater harmonization is still needed.
Process control is essential for using continuous hot-melt extrusion to enhance solubility.
This specific guidance refers to a DCT as a clinical trial where some or all the trial-related activities occur at locations other than traditional clinical trial sites.
The new research and development capacities set the stage for completion of product development for LEON’s manufacturing devices and will be used to showcase the devices and provide process development services to clients using LEON’s equipment.
The acquisition was completed through the merger of a wholly owned subsidiary of Sanofi with and into Provention Bio.
INTERPHEX was back in full swing with Keynote sessions highlighting cutting-edge technologies that are setting the stage for the bio/pharma industry’s future.
Strike action is impacting numerous sectors across Europe, including the bio/pharma industry.
Digital transformation to the Pharma 4.0 paradigm moves forward in process development and clinical and commercial manufacturing.
The concept of quality culture and how to enforce it are being debated by regulators and industry, says Siegfried Schmitt, vice president, Technical at Parexel.
The engine that drives pharmaceuticals forward, its workforce, is now very low on fuel.