Analytics

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.

Marianna Tcherpakov, PhD, director of Business Development, CMC Services, at Frontage Laboratories, spoke on the CDMO’s role in tackling complex technical challenges to enable startup biotechs solve scale up problems.

Shawn Li, principal scientist at Merck & Co., known as MSD outside the Unites States and Canada, talked about the importance of properly characterizing HCPs in the biomanufacturing process.

Bala Addepalli, PhD, Director, R&D New Modalities Portfolio, Waters Corporation, discussed trends in new analytical tools for RNA characterization and gave highlights of his talk at AAPS PharmSci 360.

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.