Analytics

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.

Lonza’s SimpliFiH Services addresses bioavailability challenges with drug substance, solid-state characterization, and drug product for first-in-human studies.

Lonza’s fully automated plate-based PyroTec PRO Robotic Solution accelerates endotoxin testing of parenteral pharmaceuticals.

Cambrex’s expanded quality control laboratory supports generic API development.

The companies will join forces on a research project to develop end-to-end workflows for the preparation, characterization, and monitoring of biotherapeutics using liquid chromatography-mass spectrometry.

The Quartic Platform is a new, AI-powered smart manufacturing platform that can be integrated into legacy facilities and manufacturing processes.

Laboratory test methods evaluate cleaning agents and cleaning process design for removing resin residues from the surfaces of non-dedicated chromatography columns systems.

Characterizing particles and understanding bulk powder behavior is critical to get the best pharma product.

It is important to address manufacturing problems associated with the shorter shelf-life of pegylated L-asparaginase (pegaspargase) upon long-term storage in the form of a solution.

Confidence in the quality systems and scientific competence of the API manufacturing team is essential.

Supplier vetting and monitoring-plus comprehensive testing-ensure quality of raw materials.

Laboratory testing found that a novel approach reduced the time required for sample preparation from hours to minutes. This article summarizes test methods and results.

Waters debuted a range of new TA Instruments innovations and the BioAccord System at Pittcon 2019 in Philadelphia, PA, on March 17–21, 2019.

Katalyst D2D from ACD/Labs enables the design, planning, execution, and analysis of high throughput (HT) experiments. The web-based application was introduced at Pittcon 2019 in Philadelphia, PA.

The LenS3 Multi-Angle Light Scattering (MALS) detector, presented at Pittcon 2019 in Philadelphia, PA, uses a new approach for measuring molecular weight and radius of gyration of synthetic polymers, polysaccharides, proteins, and biopolymers.

Microsaic Systems showcased its new MiD ProteinID point-of-need mass spectrometer at Pittcon in Philadelphia, PA, from March 18–21, 2019.

Sartorius introduced the Cubis II portfolio of laboratory balances at Pittcon 2019 in Philaphelia, PA.

Bruker highlighted new analytical systems for several industry applications, including pharma, materials science, and clinical/preclinical research.

The new automated cloud-based tool allows for the design of targeted single-cell DNA custom panels.

Sartorius Stedim Biotech (SSB) and Novasep will partner to develop systems for membrane chromatography using Novasep’s BioSC platform and SSB’s single-use technology.

Understanding the API, delivery mechanism, and excipient functionality is essential to solving drug solubility challenges.

Determination of sodium chloride level is critical for assessment of purity of yeast extracts. This case study demonstrates the validation of an ion chromatography method as a suitable analytical approach.

HPLC coupled with charged aerosol detection is a suitable analytical technique to quantitate and characterize polysorbate-80 in therapeutic products; allowing quality assessment of raw material, content confirmation during manufacturing, and monitoring product stability.

Harmonization of best practices and regulatory requirements will enable developers to find the best stability testing approach.