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).
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Whitepapers & App Notes
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.
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).
Guidance on generating an intelligent, automated workflow for batch-release analysis of an active pharmaceutical ingredient (API).
Find out how to simplify your compliance process and connect data from multiple stakeholders with SAP Advanced Track and Trace for Pharmaceuticals.
How ion chromatography can help to modernise and simplify out-dated USP methods for ion analysis.
To achieve stable and reproducible results can be a challenge in PCR. This document shows facts you should consider when purchasing a PCR cycler.
Learn how to design, plan, execute and analyse catalyst screening experiments in an efficient manner.
Simultaneous detection of amino acids and organic acids by a single method, therefore reducing analysis time and costs.
This whitepaper considers sterility testing to support pharmacopoeial monographs with an emphasis on products that are difficult to test or validate.
Electronic records and electronic signatures in the regulated environment of the pharmaceutical and medical device industries.
This whitepaper provides a roadmap for assessing and selecting the right partner to get promising biological therapies to patients quickly.