Search results for " formulation"
Article
mRNA: The messenger - LNP formulation
Join us for part 5 of mRNA: the messenger, where we discuss key considerations for the formulation of lipid nanoparticles (LNPs) for mRNA drug delivery, including mixing, encapsulation, polishing and …
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
Genetic Vaccine Platforms Demonstrate Their Potential
For conjugated or VLP vaccines, the appropriate carrier substance or partner molecules also need to be explored and then combined with the antigen in the formulation process.
“Whi…
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 …
Article
Monitoring and Control of Inline Dilution Processes
“The system uses different buffer families in one production run to provide all the buffer formulations, affording a high degree of flexibility. Importantly, with IC it is possible to select the feedb…
Article
Downstream Processing for Cell-Based Therapies
… expansion stage and, depending on the therapy, can include harvesting, washing, cell concentration, formulation, final fill/finish, and preservation.
Despite the fact that most CGT manufacturing…