Analytical Method Development

Single-use systems can benefit from standardized risk assessment and analysis protocols, which can facilitate the way in which processing equipment components are compared.

With the evolution of scalability of peripheral blood protein glycosylation, research has expanded for new biomarkers.

An early drug candidate screening strategy should incorporate clear targets to lessen late-stage failure.

This article introduces a control chart technique using F statistic for continued process verification of oral solid dosage forms.

Using an orthogonal approach to lipid nanoparticle analysis can increase the odds of project success.

It is important to understand regulatory requirements and study challenges to develop and validate the appropriate methods for a bioanalytical study program at the clinical stage.

A comprehensive understanding of potential material change can mitigate its impact on patient safety.

Innovations in single-cell analytics have advanced the progression of cell biology research, which has brought new understanding of disease mechanisms.

Single-cell analytical technologies can deepen the understanding of cell biology and, therefore, disease mechanisms.

By understanding potential material change, the impact on patient safety can be understood and mitigated.

This article describes the in-vitro permeation test study data processing procedures and FDA statistical mathematics of evaluating a generic topical drug product, acyclovir cream, against its reference product.

Analyzing elemental impurities in drug products is—much like other analytical testing—primarily aimed at ensuring patient safety.

Dissolution testing has seen recent trends that have led to increased data integrity solutions as well as an increase in biorelevant testing techniques.

FDA continues efforts to incentivize drug manufacturers to follow higher data integrity requirements.

The “cloud lab” is a virtual laboratory setting that can enable scientists to more quickly advance research.

Using more exacting analytical tools can give a clearer assessment of gene-editing outcomes.

The challenges of conducting protein characterization can be overcome through the use of technologies that empower scientists in their analytical work.

The author introduces a practical approach to determining the best estimate of probability for passing multiple stage dissolution tests.

Any improper validation of methods is likely to result in regulatory agency deficiencies that range in degree of severity.

The importance of getting buy-in from regulatory authorities early in the development process is critical in order to establish meaningful specifications.

Bio-Rad has launched a range of antibodies specifically for daratumumab that inhibit the binding of the drug to the target antigen, CD38, which allows for highly specific bioanalysis and drug monitoring.

Scientists can work to overcome the challenges associated with protein characterization through empowering technologies.

The acquisition and analysis of MS data can be made more efficient with the integration of modern software tools.

Automated analytical workflows require advanced technologies to manage the higher volume of data output.

The multispecific analysis of biologics is a complex task that requires appropriate strategies.

Ensuring reliable analytical methods and bioassays requires a well-thought-out strategy for evaluating method validity and systems suitability.

The acquisition of Protein Metrics expands Insightful Science’s R&D solutions to include proteomics.

Sample preparation tends to be manually labor intensive, but automating this step helps streamline the glycosylation monitoring workflow.

Persistent bottlenecks in biocatalyst development can be alleviated through fully automated enzyme analysis.

Genezen has opened its new process development and analytical lab for viral vector production.