Analytics

Pall has introduced a 24-well filter plate that can perform cell clarification and sterilization in one step.

The company has provided updates on its COVID-19 tests under development with Adeptrix and Cytiva, respectively.

The importance of capability and capacity of a CDMO partner to deliver drug substance and product testing should never be underestimated, considering the increasing complexity of compounds in development.

Recent drug recalls in the United States from nitrosamine contamination prompt the need for more sensitive impurity testing methods and a re-evaluation of acceptable lower limit levels.

The correct mix of excipients is crucial to the success of fast dissolving/orally disintegrating dosage forms.

Advanced analytics streamlines continuous manufacturing by providing improved insights to data.

Bioanalytical studies are an important aspect of biologic drug development that may necessitate partnering with bioanalysis experts.

The company recently launched its OmniTop Sample Tubes adjustable volume sampling system, a single-use system that allows for exact sampling.

The new filters extend column life and reduce contamination while simplifying sample preparation.

The new chromatography columns provide enhanced separation for high order aggregates and macromolecules.

Ensuring the quality of data in process monitoring and control systems starts in process development phases.

A variety of assays should be used to detect bacterial, fungal, and viral contaminants in the human source cells used for cell therapies.

The extension of the company’s product offerings to include the anti-certolizumab pegol antibodies offers critical reagents for the development of assays for TNF alpha inhibitor biologics and their biosimilars.

Discovery of carcinogenic nitrosamines in three of the world’s most widely prescribed drugs is driving efforts to better detect, control and prevent their generation in APIs and finished drug products.

A comprehensive turnkey system based on LabVantage’s laboratory information management system platform allows laboratories to implement COVID-19 biobanking, testing, and research.

The company has expanded capabilities for aggregate analytics to include dynamic light scattering.

Characterizing and controlling protein aggregation is vital to ensure safety and efficacy of a biopharmaceutical product. In this interview, important aspects of protein aggregation and the tools available to address this issue are discussed.

This case study highlights analytical instrumentation and techniques that were used to identify an unknown impurity detected during routine release testing of a topical gel drug product.

Because conventional cleaning methods can risk product loss, biopharmaceutical manufacturers are often reluctant to use PDE/ADE limits to validate cleaning processes.

With new tests showing NDMA levels increase under normal storage conditions, FDA calls for removal of ranitidine products from the market.

Understanding formulation properties early in development can prevent some costly issues later on.

The company has developed mathematical algorithms that generate simple cell-count data from a few days of culture.

The new NAB Nanosep device provides increased binding capacity.

The acquisition will expand Nexelis’ immunology testing expertise.

As compounds become more complex in nature and biological ingredients are more widely used, stability testing approaches must follow suit and provide flexibility for developers.