Overview of a scale-up of a cell-based influenza virus production process using single-use bioprocessing equipment

whitePaper | December 31, 2021

The scope of this white paper includes GMPs relevant for mass manufacturing/batch53 processing of products intended for widescale retail marketing. Starting materials and 54 packaging components for drug products

whitePaper | May 25, 2023

CDER’s mission is to ensure that human drugs are safe and effective, meet established quality standards, and are available to patients. To advance this mission, FDA’s Pharmaceutical Quality for the 21st Century Initiative promotes an efficient, agile, and flexible pharmaceutical manufacturing sector that reliably produces quality drugs without excessive regulatory oversight.

whitePaper | April 1, 2022

In 2017, a top 20 global pharmaceutical company began a journey to digitally transform its pharmaceutical engineering and manufacturing capabilities by constructing a data integration and visualization platform, with strategic assistance and technical implementation provided by its partner Infosys.

whitePaper | December 28, 2022

Though tablet compression does not generate large volumes of fugitive dust, safe and efficient collection of whatever dust is created by this process is critical.

whitePaper | April 7, 2022

The United States defines a rare disease as a condition affecting fewer than 200,000 people in the country or one in which “there is no reasonable expectation” of recovering research and development costs.1 Examples of rare diseases include genetically-linked cancers, cystic fibrosis, and debilitating pediatric conditions like Gaucher disease and spinal muscular atrophy

whitePaper | September 16, 2022

T wice a year, we survey the cell and gene therapy landscape and ARM’s initiatives to advance the sector and provide an update to our members.