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WHO urges supply chain to take action on contaminated medicines
Key stakeholders in the medicine supply chain have been urged by the World Health Organization to take immediate action against recent cases of contaminated medicines.
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Manufacturing
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UK medical cannabis manufacturer granted GMP registration
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted a UK manufacturing facility good manufacturing practice (GMP) registration for its cannabis API.
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Pharmaceutical microbiology: key developments 2022
Here, microbiology experts Tim Sandle, Tony Cundell and AstraZeneca’s Miriam Guest reflect on key developments in pharmaceutical microbiology during 2022.
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Switzerland and US sign drug inspection agreement
To promote Good Manufacturing Practice, Switzerland and the US have signed a Mutual Recognition Agreement to improve pharmaceutical drug inspection.
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Moderna joins the Association of the British Pharmaceutical Industry
To support the UK’s investments in manufacturing and R&D, Moderna has joined the Association of the British Pharmaceutical Industry (ABPI).
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Ph. Eur. adopts revised general monographs after adding paragraph on N-nitrosamines
Adoption of revised general monographs 2034 and 2619 comes after inclusion of a new paragraph approaching N-nitrosamine impurities.
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2022 Terra Carta Seal: three pharma companies awarded
Two Big Pharma companies and one CDMO have been awarded the Terra Carta Seal, which recognises the efforts of global companies in their commitment to sustainability.
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Pharmapack Europe to launch two new zones in 2024
Two new zones will be launched at Pharmapack Europe in 2024, to support growing demand for biologics, mRNA therapeutics and contract packaging.
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GSK to pay $40 million to license multiple T cell engagers
A $40 million agreement will enable GSK to exclusively license up to four bi- and multi-specific T cell engaging antibodies.
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Moderna to obtain first acquisition for $85 million
Moderna has agreed on its first acquisition for $85 million, enabling it access to cell-free DNA synthesis and amplification technologies.
whitepaper
Case study: Expedite microbial contamination investigations
Find out how rapid microbial monitoring can help mitigate lengthy contamination investigations by identifying the root cause of high plate counts.
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WuXi STA opens its first oral solids continuous manufacturing line
Operation has begun for CRDMO WuXi STA's first continuous manufacturing line for oral solids, in Wuxi city, China.
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Bottlenecks in buffer preparation – solving downstream issues for upstream gains
The preparation of buffer solutions is a crucial component in the downstream manufacturing process for biomolecules; however, it is also one of the most resource-heavy and intensive steps. Solving these downstream issues with new approaches is critical to achieving efficiency and commercial gains within the upstream process. Here, Andrea Johnston…
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Simplify, standardise, digitalise to transform manufacturing
Here, Sanofi’s Arnaud Robert and Brendan O’Callaghan explore how advances in digital technology, partnerships and new ways of working are supporting manufacture and delivery of medicines for patients across the globe.
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Optimising bispecific antibody clonal cell selection with high-throughput analytics
It is possible to manufacture monoclonal antibodies using traditional methods, but the challenges inherent in bispecific antibodies such as low titer, mismatched chains, unwanted fragments and higher aggregation levels require a heightened analytical focus on clonal cell selection. Here, Stuart Jamieson and Alice Harrison at Lonza discuss high-throughput analytical strategies…
