There is a great need for sensitive, precise, and easily accessible analytical detection techniques for protein sequencing.

Biologics Quality Control: The Growing Need for Accessible Proteomics

The emergence of mRNA vaccines and cell and gene therapies has pushed innovation in analytical methods.

Emerging Therapies Drive Analytical Advancements

Effective analytics will eliminate failures, deviations, and non-conformances.

 Analyzing Exabytes

Topic

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

Articles

As the pharmaceutical industry prepares for changes to compendial and regulatory standards for elemental impurity analysis, QA/QC and laboratory scientists are tasked with adapting their operations to include data management, analysis, and reporting based on inductively coupled plasma–mass spectrometry (ICP–MS).

Regulatory and QA/QC Focus Elemental Impurity Analysis

Adeline Siew is editor for Pharmaceutical Technology Europe. She is also science editor for Pharmaceutical Technology.

Mass detection at the push of a button could change the way many laboratories carry out their chromatographic analysis.

New Technology Enables Integrated Chromatographic Separation and Mass Detection

Pfizer, Eli Lilly, and several other pharmaceutical companies are participating in the development of automated sampling technology and associated software that improve process control and reduce development times in biopharmaceutical manufacturing.

Sterile, Automated Sampling Enabling PAT for Biopharmaceutical Manufacturing

The Waters ACQUITY QDa Detector is a mass detector designed to bring high-quality, mass spectral data to chromatographic separations.

Waters Introduces Mass Detector for Chromatography Separations

LCMS-8050 Mass Spectrometer Increases Quality Analysis

Keith Bader is senior director of technology at Hyde Engineering + Consulting, 6260 Lookout Rd, Suite 120 Boulder, Colorado 80301.

Kelly Jordan is an engineer, at Hyde Engineering + Consulting, 6260 Lookout Rd, Suite 120 Boulder, Colorado 80301.

Richard J. Forsyth is principal consultant with Forsyth Pharmaceutical Consulting, 907 Shamrock Ct, Royersford, PA 19468, tel. 484.535.1688, forsythpharmaconsulting@gmail.com.

The authors evaluated a variety of materials of construction (MOCs) and found that visible residue limits (VRLs) were higher on some MOCs than on stainless steel. The optimal viewing conditions were dependent on the MOC and the viewing background. The risk of a cleaning failure due to visual failure for different MOCs can be mitigated or eliminated using complementary cleaning validation studies.

Ruggedness of Visible Residue Limits for Cleaning-Part III: Visible Residue Limits for Different Materials of Construction

Melanie Sena is community editor of Pharmaceutical Technology.

Software Improves Monitoring of Pharmaceutical Ingredients

Nancy Lewen is research fellow, CSD Analytical chemistry, Bristol-Myers Squibb.

The authors discuss a strategy for developing a risk-based approach for testing of elemental impurities in leachable studies.

A Risk-Based Approach to Monitoring Elemental Impurities in Leachable Studies

Cynthia A. Challener is a contributing editor to Pharmaceutical Technology.

The characteristics of tableted solid dosage drugs often depend on the granulation process, so selecting the most appropriate granulation technique and monitoring the process are crucial

Analytics

Biologics Quality Control: The Growing Need for Accessible Proteomics

Emerging Therapies Drive Analytical Advancements

Analyzing Exabytes