Search results for "analytics"

Article Essentials in Quality Risk Management
Quality risk management is an essential element of every aspect of drug development and manufacturing throughout the product lifecycle. Quality risk management (QRM), as defined in Internatio…

Article The Importance of Partnering for Bioanalytical Studies
The Importance of Partnering for Bioanalytical Studies Yakobchuk Olena/Stock.Adobe.com  Bioanalytical studies are an important aspect of biologic drug development that may necessitate…

Article Maximizing the Effectiveness of Upstream Bioprocessing Through the Combination of Lab Informatics and Instrumentation
Novel techniques including Raman spectroscopy and other advanced monitoring methods have the potential to reduce the reliance on discrete sampling points for off-line analytics such as titer measureme…

Article Methods Accelerate Biosimilar Analysis
Methods Accelerate Biosimilar Analysis Effective application of mass-spectrometry tools can optimize biosimilar analysis, reducing development time and cost. By Mario DiPaola, …

Article Evaluating E&L Studies for Single-Use Systems
Analytical methods In the three case studies, the following analytics were applied: • Headspace sampling/gas chromatography/mass spectrometry (HS/GC/MS) and gas chromatography/mass…

Article A Platform Approach for the Identity Testing of Multi-Component Cell-Culture Media
Data acquired from osmolality, glucose, and folic acid tests provides useful information for the specific identification of cell-culture media. By Satish Mallya, Benjamin Lay, Lihong McAleer, Alexa…

Article Virus-like Particles as Therapeutic Moieties of the Future
Analytical and functional characterization of virus-like particles enables process reproducibility and product consistency. By Ramesh Kumar, Manidipa Banerjee, Anurag S. Rathore Virus-like…

Article Managing Residual Impurities During Downstream Processing
…sed purities, but also the development of methods that will allow both sensitive and time-sensitive analytics.” CROs provide crucial support Achieving these goals can be difficult for pharmaceu…

Article Witnessing Major Growth in Next-Generation Antibodies
Including next-gen antibodies in pharma pipelines is considered essential for future success. By Cynthia A. Challener Next-generation antibodies are designed to be more specific and are ofte…

Article Improving PAT for Biologics
…iable data acquisition, storage, and evaluation capabilities from inline/online sensors and process analytics,” Becker asserts. Sartorius recently extended its bioreactor portfolio with automated…

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