Catalent Biologics has entered into a long-term strategic agreement to develop and manufacture an AveXis gene therapy treatment for spinal muscular atrophy (SMA), Zolgensma. / read more /
Altaire is voluntarily recalling ophthalmic products because of concerns regarding quality assurance controls in the manufacturing facility. / read more /
The draft guidance describes how content should be organized in electronic submissions for all submission types under section 745A(a) of the FD&C Act. / read more /
Sartorius Stedim Biotech has unveiled a new single-use vessel for its ambr 250 modular benchtop automated mini bioreactor system that has been specifically designed for therapeutic cell lines. / read more /
Industry practice has changed radically over the past five decades. Can laws published in the 1960s still ensure pharmaceutical quality and safety today? / read more /
Cultural and language discrepancies during an audit can be resolved using what many call a "playbook," says Siegfried Schmitt, PhD, vice-president, technical, Parexel Consulting. / read more /
The editors explore novel technologies for the formulation, manufacture,
purification, and delivery of sterile small- and large-molecule drugs including single-use systems, facilities and equipment, contamination issues, and process analytics.
