Drug Substance Analysis

The authors examine risk management relating to the quality issues of clinical-trial materials and discuss areas that would benefit from additional consideration and harmonization.

Elham Blouet from Roquette explains the importance of carbohydrates for injection and the challenges in this niche market.

Highly potent APIs (HPAPIs) represent a growing area of interest for the pharma industry. Mark Griffiths, CEO of Carbogen Amcis AG, explains why.

A Q&A with Brian Johnson, senior director of supply chain security at Pfizer, moderated by Patricia Van Arnum. Part of a special Ingredients issue.

FDA recently published guidance for preventing the cross-contamination of finished pharmaceuticals and active pharmaceutical ingredients with nonpenicillin beta-lactam antibiotics.

Gilead to Acquire Calistoga; Bayer Healthcare Appoints Former Pfizer Exec; and More.

Merck Teams with Parexel; Roche CFO to Retire; and More

Gilead Sciences to Acquire Arresto Biosciences; Sartorius Appoints Head of Lab Business; and More.

Expert and implementation working groups harmonize more guidelines and move Q11 forward.

During the 20 months before the crisis of contaminated heparin in early 2008, the US Food and Drug Administration did not inspect any Chinese heparin firms, according to a US Government Accountability Office, (GAO) report.

Roche Details Restructuring Plan; Sigma-Aldrich Names Successors after CEO's Death; and More.

Eli Lilly Acquires Avid Radiopharmaceuticals; EMA Recruiting New Director; and More

PPD and Bend Research Form Collaboration; Ricerca Makes Senior Appointment; And More.

sanofi to Cut 25% of US Workforce; AMRI Names VP of Chemical Development; And More.

Company and People Notes: Novartis Settles with US Attorney's Office; Hospira Names VP, And More.

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

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

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

Pfizer Suspends Tanezumab Program; Actavis Appoints CEO; And More.

Lonza Acquires MODA; Sigma-Aldrich Exec to Retire; And More.

The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) published its "Ten Principles on Counterfeit Medicines" last week to draw public attention to the issue.

Week Of May 10, 2010: Company And People Notes: Ariad and Merck Restructure Collaboration; Genzyme Changes Leadership; and More

FDA Approves AstraZeneca's and Pozen's Vimovo; Merck Announces Management Changes; And More.

X-ray powder diffraction (XRPD) is a key analytical technique in the pharmaceutical industry, providing direct information about the crystalline and amorphous components in pharmaceutical formulations in a non-destructive manner and without laborious sample preparation.

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)!

Vibrational spectroscopy, which encompasses near-infrared, mid-infrared and Raman spectroscopy, is an important analytical tool in the pharma industry.

Biotechnology company Genzyme reported that FDA notified the company that it intends to take enforcement action to ensure that products are made in compliance with good manufacturing practice (GMP) regulations.

Pfizer Invests In Nodality; SOCMA Approves New Members; And More.