Analytics

In this first of a four-part series, the authors provide an introduction to a practical approach for establishing specification equivalence. The regulatory basis and compliance examples from FDA observations and warning letters are included to support the need for an effective process.

The launch of Roche's cobas mass spectrometry solution will bring fully automated mass spec analysis to the clinical lab.

Automation technologies provide real potential to improve responsiveness and decision-making in drug development.

A statistical procedure based on a quality range is proposed for demonstrating comparability between pre-change and post-change process slopes in an accelerated or stressed stability study.

The company has expanded its early and late phase analytical capabilities by including GMP cell-based potency assays at its sites in Cambridge, UK, and San Diego, Calif.

Located in German, Italy, and Lithuania, the new European facilities will specialize in drug discovery and R&D services.

Avantor's newly launched expanded Innovation Center in Bridgewater, NJ, is designed for integrated workflows and features purpose-built collaboration spaces.

Capturing and curating R&D data are crucial to realizing the full value of advanced analytics.

The new cassette offers more efficient and sustainable ultrafiltration and diafiltration processes for feed volumes of 100 mL–1000 mL.

The company will be expanding its quality control testing capabilities at its San Diego, Calif. biologics development and manufacturing site.

Collecting and curating R&D data are increasingly crucial tasks for achieving the full benefits of advanced analytics.

Contract organizations offer assistance for testing raw materials obtained from outside suppliers.

The best strategy is to use a combination of complementary methods.

The Almac Group is planning a £11 million (US$14.7 million) investment to expand the company’s existing analytical laboratories.

Sartorius' new Vivaflow SU tangential flow filtration cassette offers better flexibility in lab workflows and is designed to be more user-friendly.

Viral vectors and other complex biologic modalities require more specificity and higher sensitivity to detect and distinguish contaminants.

Manual and automated inspection technologies have their own advantages and limitations.

Freudenberg Medical has introduced custom single-use assemblies for silicone extrusion and molding for biopharma applications.

Using one system for test execution and sample management, improving right-first-time, and allowing review by exception can deliver access to key lab data faster.

Thermo Fisher will add Olink to its Life Sciences Solutions business.

Although advancements in analytical drug substance testing are being made, the increasing diversity of the therapeutic landscape is necessitating further innovation.

HCPs are major process-related impurities that must be monitored throughout biologics production for clearance.

The VIOS family of incubators are known for optimal cell growth conditions and minimal contamination risk.

Here, Pavan Kumar Kunala from Almac Sciences runs through the different types of tests used to analyze drug substances to ensure quality and safety.

Advances in dissolution testing equipment are helping to meet user demands to a certain degree; however, more innovation in the space may be necessary for novel therapies, such as biologics.

The $58 million investment has resulted in a 72,000-square-foot facility with a dedicated LC–MS space and molecular suites and will bring as many as 350 new jobs onto the campus.

A statistical analysis for determining an expiration date can be applied to replicates or their corresponding averages as suggested in industry guidelines.

Biosimilar analytical assessments focus on demonstrating biosimilarity and interchangeability with the reference biologic.

The separation of deamidated capsids from non-deamidated capsids can be achieved using HIC, according to studies done by a team at Oxford Biomedica.

Digital transformation is allowing for better handling, analysis, and protection of vast data collection.