Manufacturing

President Obama's Fiscal Year 2010 (FY 2010) budget includes support for a regulatory pathway for follow-on biologics.

On March 3, the US Food and Drug Administration released a draft guidance for Industry entitled "Clinical Pharmacology Section of Labeling for Human Prescription Drug and Biological Products: Content and Format."

In a press release dated Feb. 25, 2009, the US Food and Drug Administration charged that Ranbaxy Laboratories's (Gurgaon, Haryana, India) Paonta Sahib facility falsified data and test results in approved and pending drug applications.

Also, Schering-Plough's vaccine unit, Nobilon, formed an agreement with the World Health Organization; Ore Pharmaceuticals named president and CEO; more...

Ultra high performance liquid chromatography is advantageous in a contract laboratory because it is faster, more sensitive, and relies on smaller volumes of organic solvents than HPLC.

USP's Stage 2 heparin monograph revisions address identification, potency, and impurities.

The authors investigate the effects of a polyethylene glycol plasticizer and water on cellulose acetate film properties.

Broader disclosure of drug prices and conflicts of interest are central healthcare reform issues.

Industry has changed, but its basic tenets have not. INTERPHEX's RJ Palermo discusses a 7-step process to keep pharma moving forward.

The source of a problem reveals itself after some investigation, or it may crash down on you.

Small- and large-molecule drugmakers debate whether they can replicate other industries' success with just-in-time manufacturing.

Editors' Picks of Pharmaceutical Science & Technology Innovations

Brief pharmaceutical news items for March 2009.

Contract manufacturers of APIs and intermediates report gains, but express caution.

Integrated lines, flexible machines, and high-barrier materials enhance packaging options.

The author tests the ruggedness of VRL viewing conditions and defines optimal viewing conditions.

An updated book provides essential information for scientists who monitor microbial quality.

Pharmaceutical Technology's annual survey on equipment and machinery shows fewer companies increased spending in 2008 and still fewer will increase spending in 2009 as overall economic conditions affects purchasing decisions.

The authors present a simple and material-sparing approach for estimating the powder-flow performance of previously uncharacterized single-component bulk powders when only particle-size distribution data are available.

With the economy down and multinational firms capitalizing on patents in developing countries, India's R&D sector still has a long way to grow.

After a year of increased attention on the pharmaceutical supply chain in Asia, what will be the region?s short? and long?term role?

When applied as part of a structured approach, predictive modelling can provide deep process and product understanding, and can enable true, continuous process validation as envisioned by ICH guidelines.

PAT guidance has been available from FDA for more than 4 years, but there have been no apparent breakthroughs in large-scale upstream production. Will companies consider using on?line chromatography to change this?

Enshrined in the concept of Quality by Design is the premise that optimized pharmaceutical manufacturing requires detailed understanding of products and processes. With this in mind, many benefits can be achieved by combining modern powder characterization techniques with real processing experience.

This month's expert examines the most appropriate technique for checking raw material quality. What technique would you recommend for quality checking of raw materials?