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The first South Korean vaccine manufacturing facility to achieve EU-GMP certification from the European Medicines Agency (EMA) is being expanded to support global supply of a pneumococcal conjugate vaccine.
Between 9 - 12 April 2024, the world’s leading trade fair analytica will once again open its doors in Munich to the international laboratory industry. At analytica, industry experts, exhibitors and visitors gather to explore the latest developments in laboratory technology, analysis and biotechnology. The fair, covering the entire spectrum…
In its recent responses to FAQs relating to Annex 1, the European Medicines Agency (EMA) discusses bioburden guidelines for good manufacturing practice (CGMP) and good distribution practice (GDP).
As part of the Prescription Drug User Fee Act (PDUFA) and the Biosimilar User Fee Act (BsUFA) reauthorisation negotiations, the US Food and Drug Administration (FDA) has issued new draft guidance on alternative tools for assessing drug manufacturing facilities.
A new cGMP filling line is set to be built at Lonza’s Stein site in Switzerland, expanding filling capacity and enabling the handling and filling of bioconjugates for commercial supply.
A UK CDMO is now permitted through MHRA certification to produce clinical supply of gene therapy AAV, including bioprocess through to cGMP manufacturing.
Europe’s largest microbiome ecosystem therapies manufacturing facility is set to begin production by the end of Q3 2023.
In a collaboration between the Institutes of Health (NIH) and CDMO Exothera, an intranasal vaccine for SARS-CoV-2 will be manufactured for use in a clinical Phase I/II trial in Africa and the US.
Several FDA warning letters distributed to pharmaceutical manufacturers in 2023 have warned of numerous corrective and preventive action (CAPA) compliance concerns.
Reliable, intuitive and simple to use. Bringing ELGA's ultrapure water purification to GxP Quality Control Laboratories.
A new manufacturing facility for sterile injectable drugs has opened in France, housing lines for products such as antibody drug conjugates.
Operation has begun for CRDMO WuXi STA's first continuous manufacturing line for oral solids, in Wuxi city, China.
A review of the last decade of FDA warning letters finds quality control operations, manufacturing process validation, and data record and integrity are the key points of scrutiny.
The new general chapter, Balances for analytical purposes (2.1.7), sets out clear requirements for equipment that is the cornerstone of every analytical procedure in the European Pharmacopoeia.
Here, colleagues from University Hospitals Bristol and Weston NHS Foundation Trust (UHBW) share the beneficial impact of reduced cleanroom environmental contamination following an upgrade to their facilities and procedures.
