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© 2020 MJH Life Sciences and BioPharm International. All rights reserved.
© 2020 MJH Life Sciences™ and BioPharm International. All rights reserved.
October 19, 2020
The facility will include a high-speed sterile line for live virus filling, a line for standard fill/finish, cleanroom capacity, labs, warehousing, and offices to support production.
The much-anticipated meeting of FDA’s vaccine advisory committee this week is slated to address a number of critical issues related to testing and approval of vaccines to prevent COVID-19 infection.
October 13, 2020
The unexplained illness in a study participant is being reviewed and evaluated by an independent data safety monitoring board and internal clinical and safety physicians.
The company will supply its LIMS to the Walter Reed Army Institute of Research (WRAIR) to support vaccine production programs for COVID-19 at WRAIR’s pilot bioproduction facility.
October 09, 2020
Rentschler will handle the downstream processing to provide highly purified drug substance at its headquarters in Laupheim, Germany.
October 07, 2020
The guidance provides recommendations for data and information needed to support an EUA for COVID-19 vaccines.
October 06, 2020
The study, entitled CV-NCOV-002, is being held in Peru and Panama and has enrolled 690 participants, including older adults ages 61 and above, and younger participants 18 to 60 years old.
Experts fear confusion over allocation process, cold-chain requirements, IT systems.
October 01, 2020
Fill/finish inspection for vaccine vials and syringes must remain GMP-compliant while aiming for fast, efficient methods.
Misleading messages contribute to eroding trust in public health agencies