Analytical Methods

Analysts should understand how a monograph, together with the associated general notices and general chapters, relate to their responsibilities under good manufacturing practices.

Glycoengineering is growing in importance as a technique to improve antibody therapeutic efficacy, safety, and product quality.

This article discusses standardized analytical method-transfer kits that have been developed to streamline method transfer and site certification at Eli Lilly. Use of these kits has been proven to improve overall efficiency and to reduce cost and time requirements for method transfer.

The company’s new CytoML Experiment Suite fully automates each stage of the flow cytometry data lifecycle, allowing for clearer data visualization and analysis.

The increased use of single-use bags in biologic manufacturing poses the risk of pinholes and other defects that cannot currently be tested for.

Current and newer biologic modalities pose increasingly complex challenges to the detection and characterization of protein aggregates.

Thermo Fisher Scientific is increasing access to cry-electron microscopy with the help of contract research organizations.

The award will help a bioanalytics startup commercialize instrument technology for pharmaceutical antibody manufacturers.

The company has launched a residual GMP-compliant test and dual sourcing opportunity designed to increase compliance and reduce risks for ATMP manufacture.

The investment will allow for the expansion of analytical R&D efforts and will support the company’s reference materials business.

The company’s SLIM technology has been a part of the company’s accelerated growth by offering enhanced R&D analytics.

Data from migration kinetics studies can be used to develop models that predict levels of leachables and extractables at different temperatures and time points.

Glycoengineering is growing in importance as a technique to improve antibody therapeutic efficacy, safety, and product quality.

The European Directorate for the Quality of Medicines and Healthcare (EDQM) has published a new general chapter (2.6.32) in the European Pharmacopoeia (Ph. Eur.) supplement 10.3.

Appropriate analytical assays are needed to determine and ensure that biosimilar critical quality parameters are on track.

Safeguarding against microbial contamination requires rapid detection and innovative technology.

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

Advanced data analytics, including statistical modeling and machine learning technique, can enable more efficient and reliable bioprocesses.

Tools such as manufacturing execution systems, artificial intelligence, and software innovations are useful for enhancing data integrity protection.

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.

Next-generation therapeutics and regulatory requirements create demand for complex, fit-for-purpose tests.

In this peer-reviewed article, the authors present a series of experimental studies showcasing the performance of MMS in secondary-structure biopharma characterization and compare it with conventional FTIR data.

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.

Demonstrating interchangeability can ensure biosimilar substitutability at the pharmacy level.

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

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.

Eurofins DiscoverX partners with VelaLabs to enable VelaLabs to perform highly reproducible potency lot release assays under GLP/GMP conditions.