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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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.
After first payment of $1bn to Biogen, Samsung Biologics has now fully acquired Samsung Bioepis.
Ami Polymer are experts in manufacture of silicone tubing, hose and single use assembly with PPE components, which is demanded in pharma/biopharma industry.
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.
In 20 years BIOCAD grew from a pharma startup outside of Moscow to an international company producing both biosimilars and original products.
This webinar shares study data, research experience and best practices to mitigate the risks of single-use bags in the frozen distribution steps.
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…
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.
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.
In this application note, we show a successful example of the adaptation of a human recombinant protein-expressing HEK293 cell line.
This whitepaper considers sterility testing to support pharmacopoeial monographs with an emphasis on products that are difficult to test or validate.
This whitepaper provides a roadmap for assessing and selecting the right partner to get promising biological therapies to patients quickly.