Novel and advanced therapies have come on in leaps and bounds over the past decade. Some cell and gene therapies have already reached the approvals stage, while others have now entered the later development stages. As a result, manufacturing process consistency, GMP standards and more must now meet more formal…
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Edward Samuel, EVP Technical Operations at Achilles Therapeutics, explains why industrialised manufacturing and scale-up of autologous cellular immunotherapies will require fully closed systems and process automation.
Application note: BIOBALL® Burkholderia cepacia complex strains performance testing for USP <60> growth promotion requirements
Over the years, the presence of objectionable microorganisms has been identified as the leading cause of non-sterile drug product recalls in the US.
EPR Podcast Episode 7 – Collaboration in ATMP development – Jérôme Larghero and Julien Textoris, bioMérieux
How important is collaboration in ATMP development? What can be done to expedite ATMP manufacturing and release? Find out about all this and more in this podcast with bioMérieux.
EPR Podcast Episode 5 – ATMP manufacturing and QC – Rey Mali, Accellix and Félix Montero-Julian, bioMérieux
Join Rey Mali and Félix Montero-Julian as they discuss the challenges facing the manufacture and QC of advanced therapy medicinal products (ATMPs) and potential solutions.
This application note discusses some of the critical issues users experience with endotoxin testing around accuracy, flexibility, sustainability and platform cost.
While each pharmaceutical validation provides the necessary foundation for the testing of specific products via recombinant Factor C (rFC) without external reference, there are also several published studies that support the equivalence of recombinant technology.
Pharmaceutical and medical device manufacturers can now use the compendial chapter 2.6.32.
Expert view: The right endotoxin detection solution for you – bioMérieux’s complete portfolio of rFC endotoxin assays
As part of any general pyrogen testing strategy, the detection of even minute traces of the highly pyrogenic bacterial molecule called lipopolysaccharide (LPS, also named endotoxin) in pharmaceutical samples is mandatory to ensure patient safety.
For over 30 years, pharmaceutical and medical device product release has relied solely on endotoxin assays using Limulus Amebocyte Lysate (LAL). This article addresses the potential risks associated with relying on a single raw material in a fragile supply chain and explores alternative testing options.
In this whitepaper, bioMérieux describe the potential application of BioFire® FilmArray technology – a well-recognised technology used in infectious disease diagnostics – for rapid at-line detection of mycoplasmas in the pharmaceutical industry.