Search results for " formulation"

Article Applications of isothermal titration calorimetry and differential scanning calorimetry in biopharmaceutical formulation development
Knowledge of mechanisms of protein-excipient interactions is critical as it would enable a rational approach towards optimizing protein formulations.  Calorimetric investigations to explore protei…

Article Development and optimization of protein formulations
This white paper describes the use of differential scanning calorimetry (DSC) as a method for rapidly determining optimum solution conditions for protein formulation stability. Screening formulations …

Tip Differential scanning calorimetry (DSC) for formulation screening
Application note 28-9870-37, Applications of differential scanning calorimetry in the development of liquid formulations for protein biopharmaceuticals, gives background and results from experimental …

Article DoE Provides Benefits, but Preparation Is Necessary
28-29  Using a design-of-experiment (DoE) approach allows a formulation development scientist to examine the formulation design space in a statistically significant manner from the beginning of ex…

Article Evaluating Surface Cleanliness Using a Risk-Based Approach
Further consideration should be given to formulation, toxicity, analytical method for residuals, rinsability of components, stability of closed and open containers, and assurance that the product will…

Article Predicting Progress in Protein Aggregation
In silico analysis and the evaluation of formulability, aided by new analytical tools such as hydrogen deuterium exchange mass spectrometry (HDX MS), are enabling the improved design, production, and …

Article Bioterminology: A Guide to the Biopharmaceutical Lexicon
Materials that are actually removed from a container or closure by a given formulation or product. (See leachables)  extraction Liquid-liquid extraction is a process in which a solute is removed …

Article Impact of Manufacturing-Scale Freeze-Thaw Conditions on a mAb Solution
A number of non-optimal formulation, manufacturing, or storage conditions often cause instability of mAbs, which in turn can affect the bioactivity of proteins (7). Freezing and thawing are integr…

Article Detecting Protein Aggregates and Evaluating their Immunogenicity
“These stages include formulation composition, presence of microbial or vial contaminants during cell culture, and storage,” notes Olcott. Work by Hasija et al. (2) on forced degradation studies in va…

Article High-Throughput Process Development in an Historical Environment
About 100 delegates from 13 different countries joined the discussions on HTPD case studies in upstream, downstream, and formulations, as well as modeling, data analysis, and analytics. A new session …

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