Wuxi, China, October 28, 2021 –WuXi Biologics (“WuXi Bio”) (2269.HK), a global company with leading open-access biologics technology platforms, announced that it has completed a remote GMP inspection by Health Canada for its drug substance facility (MFG2) in Wuxi city. There ...
GMP, good manufacturing practices; GCP, good clinical practices; GLP, good laboratory practice; MHRG; Medicines and Healthcare Regulatory Agency; OBM, Osteogenic Bone Matrix; PIC/P, Pharmaceutical Inspection Convention and Pharmaceutical Inspection Cooperation Scheme; PTCA, percutaneous transluminal coronary...
Whether the government published GMP requirements and whether the MRA uses a computerized information management system have the two highest discrimination scores. These high scores indicate that the governments with the best underlying regulatory infrastructures have these elements. On the other hand, whet...
(Bionovas, Toronto, Canada). The synthesized cDNA was subjected to quantitative PCR analysis (LightCycler 480 SYBR Green Real-Time PCR system) using primer pairs specific to the VPl region of EV71 PI RNA. Human β-actin gene expression was used as an internal control. The PCR conditions ...
This study was funded by the UK General Medical Council (RMS 113361). The NIHR Greater Manchester Patient Safety Translational Research Centre (GMPSTRC-2012-1) funded the corresponding author’s time spent in this project. MP is also a co-investigator in the Evidence Synthesis Working Group (...
GMP: Good Manufacturing Practices HRMS: High-Resolution Mass Spectrometers IPED: Image and Performance Enhancing Drug IR/UV: Infrared/Ultraviolet LC-HRMS: Liquid Chromatography coupled to High Resolution Mass Spectrometry LC–MS: Liquid Chromatography coupled to Mass Spectrometry MRM: Multiple Rea...