Whitepapers

Three major workflows for characterizing biopharmaceuticals on a LC-MS platform: intact mass analysis under native and denaturing conditions, subunit analysis complemented with Middle-Down analysis, and peptide mapping.

This paper describes the inner workings of digital mass flow controllers to gather, generate, and communicate process data. Utilize this data to improve process control, system uptime, diagnostics, preventive maintenance and yields.

This study demonstrates the use of the workflow for sequence variant assessment and to monitor the variability of product quality attributes in biosimilar when compared to its originator.

Precise temperature control has a significant influence on performance and quality in chemical process engineering. Unistat temperature control systems ensure stable process conditions in research laboratories and pilot plants worldwide.

Paper examines how cryogenic cold-temperature solutions are gaining favor versus traditional mechanical refrigeration methods in the manufacturing, storage, and distribution of vaccines due to their enhanced efficacy, stability and yield.

Cytiva experts answer your top questions about challenging host cell protein assays to improve risk mitigation.

This white paper investigates best practices and tangible benefits associated with a risk-based quality management (RBQM) approach to clinical trial management.

Assessing a drug candidate early in discovery and development minimizes the risk of costly downstream failure. This white paper illustrates the application of automated DLS for aggregation and stability investigations.

This paper details various USP subvisible particulate tests used to assure the minimization of particle counts in intravenous injections and the requirements and technologies used to meet them.