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Gilead to support Indian COVID-19 crisis with donation of remdesivir
The company will donate 450,000 vials of remdesivir and support its licencing partners in expanding and accelerating the production of the drug.
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Manufacturing
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Recombinant bacterial endotoxin testing techniques shown to be inferior
An evaluation comparing Limulus amebocyte lysate to recombinant alternative assays has found that the recombinant reagents had markedly low recovery of endotoxin activity.
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New research could allow bioproduction of toxic compounds
A paper shows implementing riboregulated switchable feedback promoters enables cells to produce the precursors for potentially toxic chemotherapeutic and anti-malarial drugs.
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Adding vesicles to cell-free gene expression (CFE) systems increases yield
Enriching cell-free gene expression system extracts with membrane bound vesicles can significantly increase their ability to produce protein-based products, shows study.
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Expediting the set-up of a manufacturing site: Rukobia case study
In this article, learn from GlaxoSmithKline’s and ViiV Healthcare’s team as they discuss the key elements that enabled them to build and set up a dedicated manufacturing facility for Rukobia in only 15 months.
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Cleanroom infrastructure innovation to fulfil the needs of cell and gene therapies
Biopharmaceuticals have transformed the patient care landscape, but alongside this step change in treatment capability comes the need for a similar paradigm shift in manufacturing capability. Here, Maik W Jornitz, President & CEO of G-CON Manufacturing Inc. highlights how cleanroom infrastructure must develop to keep pace with ever evolving industry needs.
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Trends to watch out for in the pharmaceutical robot market
EPR’s Hannah Balfour summarises a market research report exploring trends in the pharmaceutical robot market between 2021 and 2028.
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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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Is the compendia-recommended microorganism test panel truly representative?
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.
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Discussing developments in RMM with Dr Tim Sandle, Bio Products Laboratory
In this video, Dr Tim Sandle explains how COVID-19 has impacted the application of rapid microbial methods (RMM) and much more...
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Case study: Finding impurities and controlling formations at release
Case study example regarding finding impurities and controlling formations at release.
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FDA halts COVID-19 vaccine production at Emergent facility
The FDA has requested Emergent’s Bayview plant be closed and vaccine production halted while the agency investigates potential good manufacturing practice (GMP) violations.
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Plasma-derived therapies require a mastery of advanced bioproduction techniques
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…
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Under the microscope: The challenge of quality control for adenovirus and RNA-based vaccines
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…
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Bioprocessing & Bioproduction In-Depth Focus 2021
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.
