Medical Regulations Gate - MRG

MEDICAL

BioCina | June 14, 2022

BioCina, a leading contract development and manufacturing organization (CDMO) today announced that the company has expanded its CDMO service offering to include the manufacture of plasmid DNA (pDNA) in a new dedicated GMP suite. The suite is equipped with up to 300 L single use fermentation capacity and suitably scaled downstream processing equipment. To complement GMP manufacturing, a broad range of analytical methods have been developed to support in-process, release and stability testing of p...

MEDICAL

Cytiva, Pall Corporation | June 02, 2021

Danaher Corporation's Life Sciences platform has acquired precision NanoSystems (PNI). PNI is a global leader in technologies and solutions for developing genetic medicines, including mRNA vaccines and therapeutics. PNI will join Danaher's Life Sciences platform and complement other businesses in the forum, including Cytiva and Pall. "PNI has advanced several exciting innovations, and we're thrilled to welcome this talented team," says Emmanuel Ligner, Danahe...

MEDTECH

QIAGEN | August 16, 2022

QIAGEN N.V. announced the launch of the QIAstat-Dx Viral Vesicular Panel RUO, the first syndromic test to differentiate between monkeypox and five other pathogens which cause similar symptoms. The new panel ­– currently for research use only comes in cartridge form to run on QIAGEN’s QIAstat-Dx automated syndromic testing devices. It tests for the two known forms of monkeypox virus herpes simplex virus 1 HSV2, human herpesvirus 6 (HH6), varicella-zoster virus and e...

MEDICAL

Merck | December 28, 2020

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today declared it has gone into a agreement with the United States Government to help the turn of events, assembling and introductory dispersion of an investigational biological therapeutic (CD24Fc, to be named MK-7110) upon endorsement or Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). Merck acquired MK-7110 through the securing of OncoImmune, a privately held, clinical-stage biopharmaceuti...