Analytics

Automation promises to connect biomanufacturing processes more closely, and to bring greater efficiency to the manufacturing floor.

FDA is collecting public comments on a draft guidance for bioanalytical method validation developed by ICH.

The Gyrolab E. coli HCP Kit quantifies host cell protein impurities from Escherichia coli expression systems used in biotherapeutic production.

Cytek Biosciences’ Cytek Aurora advanced flow cytometry system uses five lasers to enable seeing more than 30 colors from a single sample.

SCIEX added new innovations to improve laboratory workflows and data acquisition from samples.

The new flow cytometer system boasts enhanced sensitivity and user-friendly features.

The new platform from Berkeley Lights allows scientists to more easily analyze large numbers of cells in a short period of time.

The new flow cytometer offers full automation and enhanced software to alleviate bottlenecking.

A survey conducted by Agilent Technologies and research and consulting firm Frost & Sullivan revealed pressing issues and objectives experienced by lab leaders around the world.

Using Lean, Six Sigma, and other Op Ex practices is helping one contract development and manufacturing organization (CDMO) increase efficiency and optimization.

The companies will form a biometrics organization focused on delivering analytical solutions for drug development.

Cambrex has announced the completion of its new facility at its Karlskoga site in Sweden that combines new laboratories for process and analytical development.

Biotage has announced a strategic collaboration with Shandong Yingsheng Biotechnology for the development of clinical MS applications in China.

The SIMCA 16 software has enhanced functionality features that include usability improvements and increased workflow flexibility.

Shimadzu’s C2MAP-2030 system can improve operational efficiency for optimizing and controlling the cell culturing process.

Agilent’s updated portfolio of products for immunotherapy researchers provides cell-based tools for translational research and development.

Close collaboration between academic and industrial groups is vital to ensuring glycosylation models are fit for deployment.

Metrohm gains B&W Tek’s line of spectroscopy instruments as well as expertise and facilities.

Knauer has introduced new columns and screening services for the enantioseparation of chiral substances.

Leachable silicone oil may have an effect on large-molecule APIs, making it important to establish a robust analytical method to detect and quantify the substance.

Empty and prefilled syringes must pass a range of quality control tests.

Particle morphology of magnesium stearate, added as an anti-caking agent in a high water‑soluble drug substance, has an influence on the dissolution rate of compressed tablets.

More manufacturers are embracing MAM, which simplifies biopharmaceutical product quality testing, and facilitates the measurement and monitoring of critical quality attributes.

In Karl Fischer analysis, sulfur trioxide can react with DMSO, invalidating test results. The authors evaluated different instruments and methods, described in this article, to minimize the impact on results.

This article takes a look at current practices for cleaning and sterilizing biomanufacturing equipment used in a multi-product versus single-product setting.