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A Better Approach To Aseptic Process Simulation For Lyophilized Products By David A. Hamilton (MSD), Ted Tharp (AbbVie), Orla McGarvey (Lonza), Martin Frei (Lonza), Michael Dekner (Takeda), Shyam B. Mehta (Teva Pharmaceuticals), Xiaodong Chen (Bristol Myers Squibb), Nunzio Zinfollino (Merck), Stefan Schneid (Bayer), Josh Briggs (Biogen), Melissa Schreyer (Janssen Research & Development), and Deborah Hill (BioPhorum) Proposed 2020 revisions to EU Annex 1 1 with respect to aseptic process simulation (APS) for lyophilized products have prompted extensive discussions on best practices for process simulation of the lyophilization unit operation. This article serves to address these expectations and present a risk-based, holistic best practice approach for APS for lyophilized drug products. ....
Dear Shareholders, On behalf of the board ( Board ) of directors ( Directors ) of Austar Lifesciences Limited ( Company ), I am pleased to present the annual report of the Company and its subsidiaries (collectively as the Group or AUSTAR ) for the year ended 31 December 2020 ( Year ). The year 2020 has been a challenging year for any individual, company and organization under the impact of the COVID-19 pandemic and its consequential policies. From a global perspective, the pandemic has not been slowing down even though China s pandemic conditions had become far stable and under extraordinary control. Under such conditions, the Group has been reacting, responding and acting during such extraordinary moments. Our colleagues could never have believed they were able to deliver our critical utilities and bioprocess systems to our COVID-19 vaccine manufacturer clients within 3 months from order to completion of installation and commissioning with ....
ISPE Gathers Global Health Authorities to Discuss Remote/Distant Assessments, Audits, and Regulatory Guidance Share Article ISPE will convene regulators, auditors, remote auditors, and inspectors representing 11 regulatory agencies from around the world at the 2021 ISPE Global Pharmaceutical Regulatory Summit for critical discussions on onsite inspection challenges due to COVID-19. This event is another means for ISPE to provide a platform to enable these transparent conversations in the industry that includes representatives and perspectives from worldwide regulatory authorities. NORTH BETHESDA, Md. (PRWEB) April 13, 2021 The International Society for Pharmaceutical Engineering (ISPE) will convene regulators, auditors, remote auditors, and inspectors representing 11 regulatory agencies from around the world at the 2021 ISPE Global Pharmaceutical Regulatory Summit for critical discussions on ....