FDA warning letters highlight data integrity issues
Recent FDA Warning Letters have identified three manufacturers whose facilities held data integrity violations related to microbiology and environmental monitoring.
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Recent FDA Warning Letters have identified three manufacturers whose facilities held data integrity violations related to microbiology and environmental monitoring.
In our third instalment of EPR's exclusive ‘Microbiome therapeutics: microscope to medicine’ series, Tue Hodal, Chief Technology Officer and Lorenz Rindisbacher, Chief Quality Officer, Bacthera, explore how live biotherapeutic products (LBPs) represent a transformative shift in medicine, highlighting their unique challenges and potential.
An inlet conveyor with a linear diffuser inside a continuous tablet coater offers better air flow distribution for tablet drying, research by IMA Pharma suggests.
12 March 2024 | By Actylis
Join us as we look at how the outsourcing of buffers is helping biopharma drug manufacturers to streamline their processes.
According to Olympus Corporation, concerns about the non-vascular metallic stents were found post-closing following the agreed acquisition of Taewoong Medical Co., Ltd.
While fungal contamination detection in pharmaceutical manufacturing remains a challenge, preventive practices and policies must be followed, research states.
A study investigating microbial risks of the entire manufacturing process has identified MALDI-TOF MS as a promising first-line tool for pharmaceutical environmental monitoring.
A joint government and industry investment of £92 million intended to expand UK medicine manufacturing facilities, form part of a new £360 million funding package from the UK government.
Following the first industrial-scale facility for targeted alpha therapy (TAT) production in Europe beginning construction, in this exclusive Q&A, Julien Dodet, CEO of Orano Med, elaborates on the key trends in radioligand therapeutics and why TATs hold significant advantages as cancer treatments.
Erik Vaessen, Chief Business Officer at FUJIFILM Irvine Scientific, reveals the benefits of continuous culture processing and considerations for optimal bioproduction.
Bringing a wealth of structural information and direct quantification to the lab or plant, the Fourier PAT benchtop NMR reduces tedious calibrations and increases (bio)process understanding and control, hence further reducing risks and cost.
With the integrity of a greater number of third-party-generated data called into question, the US Food and Drug Administration (FDA) is unable to rely on the data to grant marketing authorisation, the agency asserts.
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…
One project supported through £11.5 million investment will focus on biocatalytic nitro-reductions in scalable continuous flow reactors, using paracetamol as a case study.
EPR Issue 1 includes articles on separation & purification, process analytical technology and drug delivery. Register your details now to download this exclusive content.