Search results for " variability"
Article
Predicting Progress in Protein Aggregation
Techniques to enable the design and formulation of stable, protein-based therapeutics.
In silico analysis and the evaluation of formulability, aided by new analytical tools such as hydrogen deut…
Article
2014 Manufacturing Trends and Outlook
Single-use systems and other technologies drive process efficiencies, but there is room for improvement.
In a recent survey of current trends and practices in biopharmaceutical manufacturing…
Article
State of Quality and Compliance in the Biopharmaceutical Industry
…ring processes and methods that pose quality risks, such as product contamination, excessive process variability, and lack of consistent product quality. Regulatory authorities approved these process…
Article
FDA Seeks Metrics to Define Drug Quality
Process and product performance index (Ppk) values similarly can be a sign of an optimal control strategy supported by in-depth understanding of the causes of variability for both products and process…
Article
Essentials in Establishing and Using Design Space
Knowledge of product or process acceptance criterion is crucial in design space.
Design space is generally considered to be the areas where the product or process parameters can be run safe…
Article
Overview of a scale-up of a cell-based influenza virus production process using ReadyToProcess equipment
The aim of this white paper is to demonstrate how Cytiva single-use products can be applied in the field of vaccine manufacturing. The white paper includes a brief discussion around modern vacci…