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

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Articles

The CPhI Pharma Award for Excellence in Analysis, Testing, and Quality Control went to B&W Tek for its handheld laser induced breakdown spectroscopy (LIBS) analyzer, NanoLIBS, which has been developed for rapid identification of solid materials based on elemental analysis. The instrument features a raster scan using a high repetition rate class 3B laser allowing for detection of elements including C, Li, and Be.

B&W Tek Takes Analysis, Testing, and Quality Control Award at CPhI

The next decade of drug development will depend on better ways of storing, using, and analyzing data, says CPhI advisor Bikash Chatterjee, president and chief science officer of Pharmatech Associates. But each of the following must be optimized: volume, variety, velocity, veracity, and value.

The Five V's of Smart Data Use and Management

World’s first systemFully automated sample preparation module for LC-MS

The agency published a guideline for the implementation of ICH Q3D.

EDQM Publishes Elemental Impurities Guideline

Gretchen L. Shearer, PhD, is a senior research chemist at McCrone Associates and an instructor at Hooke College of Applied Sciences, Westmont, IL. gshearer@mccrone.com.

Visual inspection of parenteral vials is the first step in a root cause investigation.

Taking a Closer Look at Parenteral Contaminants

The Chinese facility was cited for data integrity violations.

Zhejiang Medicine Receives FDA Warning Letter

New technology introduced in 2016 aids innovation growth for pharmaceutical manufacturing.

New Equipment Meets Need for Innovation in Pharma Manufacturing

This paper describes a unique Prep-rP-HPLC technique that uses a C-18/C-8 derivatized silica coated with a hydrophobic quaternary ammonium salt or quaternary phosphonium salt that acts as an additional/surrogate stationary phase (AsP/ssP).

Purification of Peptides Using Surrogate Stationary Phases on Reversed-Phase Columns

David G. Dolan is senior manager, Occupational, Environmental, and Quality Toxicology at Amgen Inc.

Mohammad Ovais is senior pharmaceutical scientist at Xepa-Soul Pattinson (Malaysia) Sdn. Bhd.

Andrew Walsh, M.S., certified Lean Six Sigma Black Belt, is President of the Center for Pharmaceutical Cleaning Innovation in Hillsborough, NJ. He can be reached at andy.walsh@centerforpharmaceuticalcleaninginnovation.org.

Conventional limit-setting techniques are not health-based and can make risk assessment more difficult.

Cleaning Limits—Why the 10-ppm and 0.001-Dose  Criteria Should be Abandoned, Part II

Stability testing programs should provide drug owners the information needed to establish the proper handling, shipping, and shelf-life recommendations for drug products.

Analytics

Biologics Quality Control: The Growing Need for Accessible Proteomics

Emerging Therapies Drive Analytical Advancements

Analyzing Exabytes