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ebook: Proactive clinical supply planning
The importance of thoroughly planned resupply strategies in maintaining clinical supply inventories as studies move into late phase.
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Biosimilars
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Article: Clinical and commercial outsourcing
The demand for biologics and high potent medicines is forcing the industry to consider alternatives, such as outsourcing and integrated solutions.
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EMA’s human medicines committee (CHMP) May 2022 meeting highlights
The latest meeting saw EMA’s human medicines committee (CHMP) recommend the approval of nine new medicines, refuse two biosimilar medications and recommend extensions of therapeutic indication for six medicines.
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Whitepaper: Data integrity and 21CFR.11 for 7000RMS implementation
Learn about 21CFR.11 and Annex 11 requirements and how you can implement a rapid bioburden analyser designed to meet compliant operation needs.
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On-demand webinar: Mould contamination, investigation and remediation challenges
Most industries face mould contamination issues, including medical products, hospitals, cosmetics, paint, among others. Learn more about mould and what you can do to combat it.
![Samsung Biologics logo on a phone screen [Credit: viewimage/Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Samsung-biologics-300x278.jpg)
![Samsung Biologics logo on a phone screen [Credit: viewimage/Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Samsung-biologics-e1650536525880.jpg)
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Samsung Bioepis fully acquired by Samsung Biologics
After first payment of $1bn to Biogen, Samsung Biologics has now fully acquired Samsung Bioepis.
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Video: Ami Polymer are specialists of tubings, hose and SUS assemblies
Ami Polymer are experts in manufacture of silicone tubing, hose and single use assembly with PPE components, which is demanded in pharma/biopharma industry.
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EMA’s human medicines committee (CHMP) Feb meeting highlights
Highlights of the February 2022 meeting of EMA’s human medicines committee (CHMP) include the recommendation of 13 medicines for approval, along with updates to other drugs and COVID-19 vaccines.
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CHMP meeting highlights, January 2022
The EMA’s Human Medicines Committee (CHMP) recommended approval of Paxlovid for COVID-19 and a new gene therapy for large B-cell lymphomas.
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Article: Evolving into an international biotech market driver
In 20 years BIOCAD grew from a pharma startup outside of Moscow to an international company producing both biosimilars and original products.
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On-demand webinar: Risk mitigation for single-use cold chain distribution
This webinar shares study data, research experience and best practices to mitigate the risks of single-use bags in the frozen distribution steps.
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Nearly two years on, how are European pharma supply chains coping with COVID-19?
When the pandemic broke out in 2020, pharmaceutical supply chains showed signs of potential failure across the continent. Now, with COVID-19 cases rising once more, and an end to the problem not yet in sight, we discuss with Medicines for Europe how these supply chains are faring, almost two years…
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The weakest link – biopharma workforce development
Killian O’Driscoll, Director of Projects at the National Institute for Bioprocessing Research and Training (NIBRT), highlights the plight of a future skills shortage in the global biopharma industry as state-of-the-art therapy production evolves at a rapid pace.
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Technical paper: Low risk frozen distribution of SU bags for bioprocessing
This paper discusses the results of a study that help to mitigate the risks during frozen shipping and ensure consistent product quality in cold chain.
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Application note: Solving the aggregation problem of HEK 293 cells
In this application note, we show a successful example of the adaptation of a human recombinant protein-expressing HEK293 cell line.
