Recently added articles from Pharmaceutical Technology:
A New Start for New Cells
Jan 01, 2009; ... The incoming administration has renewed hope for stem cells, but less adequate copycats may follow. Now that the Obama administration is about to take office, you can feel the release of all that pent-up energy and frustration that has been building among researchers and drug developers ...
Will 2009 Bring Innovation?
Jan 01, 2009; ... Instead of hampering progress, cost pressures might inspire Big Pharma to get creative. Reducing healthcare costs, a priority for President Obama, will be important for everyone during our economic crisis. Promoting cheap generic drugs as alternatives to branded medicines is one possible ...
An Ounce of Rejection
Jan 01, 2009; ... True Life Cautionary Tales from the Files of "Control," a senior compliance officer Our readers discuss their best approach for handling (batch) rejection. Not so hot "We had an interesting process step that required a specific time and temperature profile," reports our ...
Report from: Pakistan
Jan 01, 2009; ... Although its domestic market is on the rise, Pakistan's market conditions have not proved welcoming enough to keep foreign investors. Pakistan's ambassador to the Philippines, Muhammad Naeem Khan, recently invited an official of the Philippine International Trading Corporation to visit ...
Zone in on: Regulation
Jan 01, 2009; ... European Commission Report: Originators Block Generics Competition The European Commission (EQ published a preliminary report in late November stating that competition in the pharmaceutical industry does not work as well as it should. The report cites evidence that originator companies ...
World Briefs
Jan 01, 2009; ... ASIA & PACIFIC Shenzhen Neptunus Interlong Bio-Technique (Shenzhen, Guangdong, China) and GlaxoSmithKline (London) signed an exclusive cooperation agreement as a preliminary step toward a joint venture between the two companies. The joint-venture team will focus on developing ...
Worth Attending
Jan 01, 2009; ... GPhA 2009 Annual Meeting Feb. 23-25, 2009, Naples, FL www.gphaonline.org Pittcon 2009 March 8-13, 2009, Chicago, ...
Worth Reading
Jan 01, 2009; ... Natural-Based Polymers for Biomedical Applications (CRC Press), Edited by RX. Reis This book reviews current research on natural-based biomedical polymers and ...
PharmTech Poll
Jan 01, 2009; ... What do you think is the most critical issue in supplying and/or sourcing pharmaceutical ingredients? 76% Achieving better transparency and visibility for improved supply-chain integrity 4% Escalating costs for raw materials and ...
Zone in on: Regulation
Jan 01, 2009; ... New Guidance for Biologics Manufacturing The US Food and Drug Administration released in early December Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologia, which finalizes the August 1999 draft The guidance provides information regarding various ...
IN THE SPOTLIGHT: AUTOMATION
Jan 01, 2009; ... Editors' Picks of Pharmaceutical Science & Technology Innovations Automation has improved efficiency and contributed to consistent quality in pharmaceutical manufacturing operations. Developments in information technology have allowed operators to record production data and improve ...
FDA at a Crossroads
Jan 01, 2009; ... Will more resources and new leadership fix FDA, or is a major overhaul in order? Last year was particularly tough for the US Food and Drug Administration. The international heparin crisis erupted just as the agency was digesting a scathing assessment of its capabilities from its advisory ...
Evaluating the Pieces of the Pharma Supply Chain
Jan 01, 2009; ... After a year of increased attention on the pharmaceutical supply chain in Asia, what will be the region's short- and long-term role? With low-cost production and a pool of scientific talent, Asia, spe- cifically China and India, has risen in pharmaceutical outsourc- ing and ingredient ...
Optimizing Small-Molecule Synthesis
Jan 01, 2009; ... Catalysis for olefin metathesis and aldol reactions and synthetic routes to natural products are some recent gains. Underlying the networking between pharmaceutical companies and custom manufacturers gathering at InformexUSA in San Francisco later this month will be the exchange of sound ...
Integration of Large-Scale Chromatography with Nanofiltration for an Ovine Polyclonal Product
Jan 01, 2009; ... The use of disposable nanofiltration technology for purification of multiple drug candidates can speed drug and process development in biopharmaceutical manufacturing. The authors examine the challenges of integrating a largescale chromatography and nanofiltration process for purification of a ...
Target Selection and Qualification: The Case of Blister-Filling and Packaging Systems
Jan 01, 2009; ... Industry associations and regulatory bodies indicate that qualification should be restricted to systems and equipment that have a direct effect on product quality. The literature does not provide guidelines for identifying critical equipment, however. The authors propose an approach for ...
The Postapproval Management Plan: A Tool to Apply Science- and Risk-Based Approaches
Jan 01, 2009; ... The concept of quality by design (QbD) has presented implementation opportunities and challenges to the pharmaceutical industry and regulatory bodies. Both groups agree that reporting of postapproval changes under a robust quality system should be based on demonstrated scientific understanding ...
Have a Say in USP Standards
Jan 01, 2009; ... The USP public-comment process exists for a reason. Industry needs to take advantage. I have been participating in activities of the US Pharmacopeia (USP) for several years, and I am continually disappointed by those in industry who claim that USPs standards are antiquated. The USP ...
Survival of the Fittest Companies
Jan 01, 2009; ... The financial crisis could lead to consolidation in the contract services industry. The pharmaceutical industry- and by extension the pharmaceutical services business - was once thought to be immune from general economic cycles, but that's not the case this time. The current global ...
PHARMA CAPSULES
Jan 01, 2009; ... Milestones Patheon Opens New US Headquarters Patheon (Durham, NC), a global provider of drug development and manufacturing services to the international pharmaceutical industry, opened its new US headquarters and analytical laboratories in the vicinity of Research Triangle Park, ...