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Over the years, the presence of objectionable microorganisms has been identified as the leading cause of non-sterile drug product recalls in the US.
Get the most detailed information about UDI – requirements, implementation and benefits. Everything that supply chain participants need to know!
3P CONNECT is your EM partner for data compliance and process efficiency, for reliable decision making and taking control of your EM.
This whitepaper gives an understanding of the evolving regulatory guidelines for cell and gene therapies, in order to bring them to market faster.
Discover why pharmaceutical companies should consider aggregation as the next step towards supply chain drug traceability.
Associates of Cape Cod, Inc. (ACC) has been a global leader in endotoxin and (1→3)-ß-D-glucans detection products and services for nearly 50 years.
This paper discusses the results of a study that help to mitigate the risks during frozen shipping and ensure consistent product quality in cold chain.
What pharmaceutical QA/QC laboratories need to know to overcome the challenges of nitrosamine impurities in drugs for cGMP testing.
The ideal CRO digital platform offers an opportunity to un-burden bureaucracy and drive data capture and integrity straight into the digital eco-system allowing earlier intervention.
A fast and reproducible gradient HILIC method was set up for the impurity analysis of the hydrophilic temozolomide.
The launch of ACC's PyroSmart NextGen™ recombinant Cascade Reagent (rCR) marks the introduction of a new sustainable recombinant LAL reagent technology for bacterial endotoxin testing (BET).
This technical bulletin discusses major regulatory updates, introduced by the FDA and EMA, regarding nitrosamines and SGS proposed risk assessment method for compliance.
In this application note, we show a successful example of the adaptation of a human recombinant protein-expressing HEK293 cell line.
This whitepaper reveals strategies to create simple, stable formulations for your sterile injectable, a solid foundation for your product’s lifecycle.
How CMC software helped a major pharmaceutical company improve process development and regulatory submissions.
