Further woes for Emergent’s Bayview vaccine production facility
An FDA inspection identified nine concerns including unsanitary conditions and ineffective practices for preventing cross-contamination at Emergent’s facility.
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An FDA inspection identified nine concerns including unsanitary conditions and ineffective practices for preventing cross-contamination at Emergent’s facility.
A recently published paper suggests the test panel of microorganisms needs to be reviewed and likely expanded to ensure it is suitable for application in the pharma industry.
In this video, Dr Tim Sandle explains how COVID-19 has impacted the application of rapid microbial methods (RMM) and much more...
Case study example regarding finding impurities and controlling formations at release.
The FDA has requested Emergent’s Bayview plant be closed and vaccine production halted while the agency investigates potential good manufacturing practice (GMP) violations.
Plasma-derived therapies and medicines provide life-changing treatments for patients around the world who suffer from serious, and often rare, diseases that affect the immune system or result from non-functioning proteins in blood plasma. Carole Resman, Executive Vice President Production at LFB, describes the complex and highly regulated manufacturing process of…
Claudia Benati, Senior Scientific Director at Eurofins BioPharma Product Testing (Eurofins BPT) and Qualified person for Advanced Therapies (ATMPs), and Dr Anke McCartney, Global Key Account Manager, Eurofins BPT, discuss the challenges faced by the pharmaceutical industry in the field of analytical testing of COVID-19 vaccines in these unprecedented times…
Featured in this in-depth focus, articles exploring why cleanroom infrastructure must transform to meet the needs of the cell and gene therapy industry and discussing a novel platform for discovering and developing genetically-targeted therapies for autoimmune diseases.
Download this in-depth focus to learn about how the logistics industry rose to the challenge of the COVID-19 vaccine rollout and the complexities of the production process for plasma derived therapies.
We offer high quality analytical testing solutions for pharmaceutical and biopharmaceutical products through all phases of drug development, from discovery through early development and commercialisation. Find out more in this guide…
ACCI has been a global leader in endotoxin and (1→3)-ß-D-glucans detection products and services for more than 45 years and has grown to be an internationally recognised leader in endotoxin detection. Find out why they should be your choice in of endotoxin experts in this guide.
Reports suggest the global sterility testing market will grow because of the expansion of pharma and biopharma, increasing R&D activities and the launch of new products.
The new chapter, to be released in May, highlights the benefits of water activity measurement, as well as potential applications and best practices for use in pharmaceutical manufacturing.
Using a new precipitation method eliminates the need for the costly chromatography process and could make antibody therapies more affordable to produce, according to Andrew Zydney.
European Pharmaceutical Review's latest journal features articles discussing the challenges and potential of antibody-drug conjugates, innovations in cleanroom infrastructure and why we need to test for heavy metal contaminants in cannabis vaping aerosols. Also in the issue, an exploration of how risk-sharing strategies could help expedite access to COVID-19 vaccines,…