The authors suggest a design strategy for an aseptic process simulation that focuses on the basic repeating unit of the process, establishing alert and action criteria for the unit itself, and using ...

According to the National Cancer Institute, immunotherapies that enlist and strengthen the power of a patient’s immune system are the “fifth pillar” of cancer treatment adding to surgery, chemotherapy ...

Dublin, Aug. 07, 2024 (GLOBE NEWSWIRE) -- The "New EU (European Union) GMP (Good Manufacturing Practice) Annex 1: Compliant Aseptic Operations Training Course" conference has been added to ...

Selkirk Pharma, Inc., a privately held U.S. pharmaceutical manufacturer specializing in the fill and finish of injectable drugs, including vaccines and biological therapeutics, today announced the ...

The industry has acknowledged only recently the significance of the contamination risk posed by humans. The authors assert that this realization, together with technological advances, will lead to the ...

Selkirk Pharma, Inc., announced the Aseptic Process Simulation (APS) qualification of its sterile manufacturing facility and newly available fill/finish capacity. This development marks a significant ...

(MENAFN- GlobeNewsWire - Nasdaq) Dublin, June 04, 2025 (GLOBE NEWSWIRE) -- The "New EU (European Union) GMP (Good Manufacturing Practice) Annex 1: Compliant Aseptic Operations Training Course" ...

(MENAFN- GlobeNewsWire - Nasdaq) This course explores Annex 1's requirements, focusing on aseptic operations, CCS, and quality assurance. Attendees gain insights into regulatory expectations, ...