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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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Vaccines
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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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COVID-19 vaccine rollout: a logistics success story
The dedication of the science community and healthcare workers in the fight against COVID-19 has been unwavering and justly praised. Yet logistics workers and the industries that support it have also achieved tremendous feats to support the resulting aid. Here, Zoe McLernon, Multimodal Policy Manager at Logistics UK, highlights the…
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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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Nanoparticles for drug delivery: next-generation biological drugs to treat inflammatory bowel diseases
Nanoparticles offer a promising alternative to conventional drug delivery that allow for more precise targeting and controlled release. Here, Dr Fabrice Navarro discusses the benefits of these nanocarriers and their potential as a therapy for inflammatory bowel diseases (IBDs).
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Inactivated COVID-19 vaccine candidate enters comparative immunogenicity trial
The Phase III trial aims to demonstrate that Valneva’s VLA2001 is more immunogenic than AstraZeneca's conditionally approved COVID-19 vaccine, Vaxzevria.
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How new risk-sharing strategies can help ensure faster access to COVID-19 vaccines
In this article, Charles River Associates (CRA) delves into why traditional vaccine procurement schemes are not fit for purpose during the pandemic and how both governments and manufacturers must adapt to manage the greater level of risk associated with pandemic vaccine development and distribution.
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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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EMA confirms Janssen COVID-19 Vaccine benefits outweigh clotting risks
The EMA’s drug safety committee has concluded that the Janssen COVID-19 Vaccine is safe for continued use, so Johnson & Johnson will resume shipments to the EU.
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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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INO-4800 COVID-19 vaccine provides cross-reactive immune responses against variants
Antibodies induced by the investigational DNA vaccine candidate, INO-4800, were found to be able to neutralise three SARS-CoV-2 emerging variants of concern.
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Novel leishmaniasis vaccine safely induces immune responses in patients
The ChAd63-KH vaccine, used to treat leishmaniasis rather than prevent in this trial, significantly improved symptoms in patients with persistent post-kala-azar dermal leishmaniasis.
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European Pharmaceutical Review Issue 2 2021
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,…
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Novavax’ COVID-19 vaccine to be included in UK’s mixed regimen study
Novavax has agreed to participate in the University of Oxford’s Com-COV2 study evaluating the safety and efficacy of regimens consisting of doses of COVID-19 vaccines from different manufacturers.
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Biologics CDMO market to double in value by 2026, suggests report
Research suggests the increasing R&D investment in and adoption of biologics will drive growth in the global biologics contract development and manufacturing organisation (CDMO) market.
