Study shows nicotinic acid (NA) to nicotinamide (NAM) ratio enables detection of early-stage microbial contaminations in cell therapy products.
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The United States Pharmacopoeia (USP)
Robust sterility testing protocols are essential to protect patients, medicine supply chains and manufacturers’ bottom lines. But how do companies build successful sterility processes?
Unveiling its Medicine Supply Map, the US Pharmacopeia (USP) showed how reliant the US pharma supply chain is on Indian API manufacturers.
USP is developing mRNA quality guidelines to support the development of innovative medicines and vaccines.
Healthcare groups including the US Pharmacopeia and American Medical Association release advice for policymakers on addressing challenges in the US supply chain.
The Bacterial Endotoxin Test, using LAL methodology, is a key in-process and final product release test for sterile pharmaceuticals and medical devices. One of the challenges with LAL methodology is overcoming interfering substances as demonstrated by inhibition or enhancement of an endotoxin challenge. Here, Bio Products Laboratory’s Dr Tim Sandle…
Glycosylation of therapeutic proteins is important to biologic drug development and is a critical quality attribute that is monitored during manufacturing. Analysis of O-glycans is technically challenging compared to that of N-glycans. In this review, Xiaofeng Shi, Saulius Vainauskas and Christopher H Taron summarise current O-glycan analytical approaches, describe the…
An evaluation comparing Limulus amebocyte lysate to recombinant alternative assays has found that the recombinant reagents had markedly low recovery of endotoxin activity.
The importance of analytical balances in laboratory operations demands that they be fit for purpose over the operating range and acceptance criteria specified in the laboratory user requirements specification. In this article, Bob McDowall, Director of R D McDowall Limited, discusses the regulatory requirements for analytical balances operating in GMP…
Reports suggest the global sterility testing market will grow because of the expansion of pharma and biopharma, increasing R&D activities and the launch of new products.
The new chapter, to be released in May, highlights the benefits of water activity measurement, as well as potential applications and best practices for use in pharmaceutical manufacturing.