Analytics

The author outlines key considerations for carrying out a structured approach to monitoring process performance and ensuring product quality.

The author describes the development of small-angle X-ray scattering and analyzes its advantages in the characterization of drug-delivery systems and large molecules. This article is part of a special Analytical Technology issue.

The authors discuss the approach taken to develop a new calibration approach, its associated protocols, and how it can be used to calculate data.

The authors review and discuss the influence of glycans on the conformation of a representative IgG1 biopharmceutical using H/DX-MS as an analytical tool.

Novartis Sells US Enablex Rights; Ricerca Names Chemistry Director; And More.

DSM and PolyTherics in Development Deal; Kite Pharma Appoints President and CEO, And More.

The US Food and Drug Administration recently issued a Warning Letter to Bristol-Myers Squibb (BMS, New York) for violations of current good manufacturing practice at the company's Manati, Puerto Rico, manufacturing facility.

Genzyme Sells Genetics Business; Bausch and Lomb Names Vice-President; and More.

US Pharmacopeia apparatuses for testing the dissolution of transdermal drugs produce good, reproducible results. Yet some scientists believe that further modifications could improve the instruments? suitability for this application.

Pfizer to Acquire FoldRx; Protalix Appoints COO; And More.

The Agilent 2100 Bioanalyzer plus the Agilent High Sensitivity Protein 250 Kit automatically detects and quantifies protein impurities down to 0.05% — meeting ICH guideline Q3B(R2)!

Company and People Notes: Lonza Acquired Vivante; PPD Appoints VP of Quality Management; And More.

Software and online monitoring are helping the pharmaceutical industry improve its corrective and preventive action programs. This article contains bonus online material.

To properly inspect based on measurement, a reference standard is crucial for comparison.

New data provide insight into pharma-industry professionals' daily lives.

In the final article of a three-part series, the authors discuss how to present a design space and evaluate its graphical representation.

The authors discuss the capabilities of immobilization technologies and the ability to use an expanded range of solvents for mobile-phase components and solvent dissolutions. This article is part of a special issue on APIs.

Utilizing integrated active radio frequency identification (RFID) and real-time asset management systems can yield commercial and compliance benefits.

Week of Aug. 23, 2010: Company and People Notes: Quark and Novartis Form Agreement; Hospira CEO Retires; And More.

Eli Lilly Ends Semagacestat Program; Selecta Appoints CEO; And More.

PharmTech's monthly newsletter, Equipment and Processing Report, reviews the Editor's Picks for the August 2010 edition from Lechler and Thermo Fisher Scientific.

Penwest and Endo to Merge; Watson Makes Senior Appointments; And More.

FDA Approves Flu Vaccines; Caraco Names COO; And More.

The author reviews test methods for microbiological cleaning processes and suggests ways to improve microbial bioburden method suitability studies.

Industry's focus on cost cutting has led to a dangerous gap in training and knowledge.

The authors discuss the statistical tools used in experimental planning and stategy and how to evaluate the resulting design space and its graphical representation.

Editors' picks of pharmaceutical science and technology innovations.

Merck and Sinopharm Sign Agreement; Agilent Appoints CFO; And More.

Pfizer Ends Second Tanezumab Clinical Program; Catalent VP Joins USP Panel; And More.

The US Food and Drug Administration has joined the Tox21 collaboration, which aims to develop ways to more effectively predict how chemicals will affect the body and environment.