Analytics

New products in tableting and granulation.

Q&A with Magnetrol International's Dan Klees

Using risk assessment properly can provide industry with a unique tool for quality control.

How to adapt a real time release approach to powder processing during drug-product manufacturing.

A roundtable moderated by Angie Drakulich.

Novartis Acquires Genoptix; Lilly Exec Becomes Savient CEO; and More.

FDA published its long-awaited guidance titled Process Validation: General Principles and Practices this week.

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

A company's contamination-control plan is an important document designed to formalize the rationale, methods, and validation of contamination-control procedures in a manufacturing facility. The author describes the role of bioburden in the contamination-control plan.

Improvements in analytical techniques may call for a re-evaluation of the biopharmaceutical industry saying that "the process is the product."

UHPLC offers increased performance compared with HPLC, including shorter analysis times and increased sensitivity.

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.

Capable of great works, pharma as a whole still yields to the lesser angels of its nature.

A Q&A with Spectrum Laboratories President Tony MacDonald.

AstraZeneca and Abbott End Program; PhRMA Elects New Members; and More.

Pfizer Recalls One Lipitor Lot; Sanofi Aventis Names Head of R&D; and More.

Thermo Fisher to Acquire Dionex; Former SOCMA CEO Joe Acker Dies; and More.

Equipment and Processing Report talked to Jonathan Seville, dean of the School of Engineering at the University of Warwick, to find out how positron-emission particle tracking could help pharmaceutical manufacturers gain process understanding.

Company and People Notes: GlaxoSmithKline acquires Nanjing MeiRui Pharma; Cephalon's CEO to remain on medical leave; and more.

Genzyme Sells Business Unit to Sekisui Chemical; Ablexis Names VP of Research; and More.

The International Conference on Harmonization (ICH) Steering Committee (SC) and its working groups met in Fukuoka, Japan Nov. 6-11, 2010.

European confidence and optimism in biotechnology is increasing, according to a survey conducted by the European Commission.

The European Medicines Agency and the Massachusetts Institute of Technology's (MIT's) Center for Biomedical Innovation (CBI) and Center for International Studies (CIS) are launching a collaborative research project with a focus on enhancing regulatory science in pharmaceuticals, according to an EMA press release.

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.

The biotechnology company Biogen Idec (Weston, MA) announced last week a major restructuring program that will refocus the company's research and development (R&D) programs, consolidate facilities, and reduce its workforce.

PQRI and FDA present Process Drift Workshop, and More.

The US Food and Drug Administration's Puerto Rico district office "may be having difficulty exercising oversight on the numerous pharmaceutical manufacturing facilities on the island," according to Rep. Edolphus Towns (D-NY), chair of the US House of Representatives Committee on Oversight and Government Reform.

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