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HPAPI facility developed to produce biodegradable contraceptive molecule
A new HPAPI manufacturing unit has been opened in France, with the capability to make a contraceptive with a superior safety profile and high level of biodegradability.
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Drug Manufacturing
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UK government inks deal for 60 million doses of Valneva COVID-19 vaccine
Valneva has agreed to supply the UK government with 60 million doses of its potential COVID-19 vaccine by the second half of 2021.
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Few CMOs equipped to manufacture cell and gene therapies, finds study
A report has said that with only 152 CMOs able to manufacture the 7,000 cell and gene therapies in the pipeline, production bottlenecks may occur.
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$65 million expansion to HPAPI manufacturing facility
The expansion will be specifically designed to manufacture high-potency active pharmaceutical ingredients (HPAPIs) and complex antibody-drug conjugates (ADCs).
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Biopharma pledges to uphold scientific integrity in COVID-19 vaccine development
Nine biopharma CEOs pledged to make the integrity of the scientific process and sufficient supply priorities in the development of COVID-19 vaccines.
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WHO says 172 economies in talks for access to COVID-19 vaccines programme
The WHO has announced that many economies worldwide may participate in COVAX, an initiative aimed at providing countries with equitable access to COVID-19 vaccines.
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Canadian government strikes deals with Janssen and Novavax for COVID-19 vaccines
The Canadian government has agreed that Janssen will supply the country with 38 million doses of its COVID-19 vaccine, while Novavax has agreed to supply 76 million doses if its vaccine.
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The new KORSCH X 3 tablet press: maximising mid-range production
The X 3 is a breakthrough in the small-scale and mid-range tablet press market segment and the latest advancement from KORSCH.
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A glimpse at how Novartis’ manufacturing and supply organisation responded to COVID-19
The rapid evolution of the COVID-19 situation has created significant barriers to normal operations, from locking down borders to the imposition of restrictions on trade and export – not to mention a surge in demand for many common medicines. Each of these events in isolation can affect production and supply,…
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Continuous manufacturing: ICH Q13
Although steps have been taken to enable the implementation of continuous manufacturing in industry, a lack of global harmonisation in regulations has slowed the adoption of this promising emerging technology. Dave Elder discusses how ICH Q13 seeks to provide a harmonised approach to support this important initiative.
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NDMA: a recall trigger for the drug development industry
Product recalls due to contamination issues can be extremely costly for companies, in addition to the associated health implications. In this article, Marc Baiget Francesch explores the potential risks associated with N-nitrosodimethylamine (NDMA) contamination, why is it such a frequent contaminant and how to detect and eliminate the risks.
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Release of sterile medicinal products – looking at the focal points
There are numerous risks and regulatory requirements that must be considered to ensure appropriate contamination control of sterile medicinal products. Tim Sandle discusses the complexities of sterility assurance and provides guidance for manufacturers to ensure that appropriate risk management processes are in place.
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Manufacturing, Packaging & Logistics In-Depth Focus 2020
The articles in this in-depth focus detail how Novartis prepared and adjusted their manufacturing and supply chain to minimise the impact of the COVID-19 pandemic and an exploration of what digitally enabled inventory processes can do to enhance FMD compliance.
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QA/QC & Analytical Techniques In-Depth Focus 2020
Included in this in-depth focus is a discussion on how to detect and eliminate NDMA impurities in medicines and an article exploring the complexities of sterility assurance, providing manufacturers with guidance.
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European Pharmaceutical Review Issue 4 2020
Within this issue find articles on the complexities of sterility assurance, how to detect and eliminate the risk of NDMA contamination and the findings from a study involving a novel formulation of cannabinoids that has been developed to treat glioblastoma. Also included are articles on the opportunities blockchain provides for…
