Analytics

How do you answer an inspector's questions? How do you validate analytical methods? One book has answers for compliance professionals.

"May you live in interesting times," goes the allegedly ancient Chinese curse. Well, these have been "interesting times" indeed for those working in the pharmaceutical industry.

Company and People Notes: ISP to raise prices, Patheon appoints CEO, more.

Company and People Notes: Cambridge Major Labs acquires ChemShop; Helix BioPharma restructures senior positions, more.

Company and People Notes: BASF raises prices on excipients; Verus Pharmaceuticals appoints president and CEO; more.

Submitting a safety update to European regulators, Novartis provided data showing its 100-mg once-daily dose of ?Galvus? (vidagliptin), an oral type 2 diabetes treatment, has more frequent liver enzyme elevations in patients than its already approved 50-mg once- and twice-daily doses.

Pfizer's Lipitor patent revoked in Germany, promotions at Charles River Labs, more.

Editors' Picks of Pharmaceutical Science & Technology Innovations

In this study, fault tree analysis applied to a water pretreatment and purification installation exposed cause-and-effect complex interrelations in possible fault events.

News and Views

Maintenance and service-related items are often the second-largest budget element in a laboratory after salaries and benefits. Within maintenance, preventive maintenance (PM) is a substantial portion of the budget. Traditionally, PM was an equipment maintenance philosophy based on replacing, overhauling or remanufacturing a piece of equipment at fixed intervals, regardless of its condition at the time. In essence, it involved fixing something that wasn't necessarily broken and this approach is still widely used in the pharmaceutical industry.

Company Notes: Gibraltar expands facilities; Allozyne appoints new president and CEO, more.

Company and People Notes: ImClone, BMS, and Merck form agreement; CRI Worldwide names new CEO, more.

Company and People Notes: Orexo acquires Biolipox, Avalon cofounder resigns, more...

Company and People Notes: Novartis and MIT to study continuous processing, GSK appoints Andrew Witty as CEO, more.

Company and People Notes: Thermo Fisher Scientific buys Priority Solutions International, Wyeth elects new president and CEO, more.

Carl Zeiss MicroImaging (Thornwood, NY) recently introduced its "Colibri" light-emitting diode (LED) light source for fluorescence microscopy. The product is "the only LED light source optimized for white-field microscopy systems," says Becky Homan, product manager for biomedical light microscopy.

To monitor and control processes or products, analytical methodology must be fit for purpose. An approach to apply quality by design principles to the design and evaluation of analytical methods has therefore been developed to meet these needs. This article features a downloadable template on which to conduct a failure mode effect analysis (FMEA).

Regulators and industry professionals provide a guide for identifying and measuring impurities.

Revisions to the United States Pharmacopeia's (USP) uniformity test require manufacturers to establish new acceptance limits. The authors present their method for calculating acceptance limits consistent with USP's revised content-uniformity test requirements.

High-performance liquid chromatography (HPLC) is a powerful tool for the enantioselective separation of chiral drugs. However, the selection of an appropriate chiral stationary phase (CSP) and suitable operating conditions is a bottleneck in method development and a time- and resource-consuming task. Multimodal screening of a small number of CSPs with broad enantiorecognition abilities has been recognized as the best strategy to achieve rapid and reliable separations of chiral compounds. This paper describes the generic screening strategy developed at Johnson & Johnson Pharmaceutical Research and Development to successfully develop enantioselective HPLC methods for chiral molecules of pharmaceutical interest.

The authors review methods for reducing analysis time and increasing throughput that are reliable and maintain data integrity.

Polysaccharide-based chiral stationary phases have been developed that comprise chiral selectors immobilized on their support rather than being physically coated. These materials are completely solvent stable, thereby increasing selectivity and and enabling the development of new chiral selectors that have been too unstable in a coated form for general use.

The combination of supercritical fluid chromatography with chiral separation media offers several analytival advantages over traditional liquid chromatography techniques.

Ultrahigh pressure liquid chromatography maximizes efficiency, but, as defined by the resolution equation, the stationary phase is still a crucial consideration when attempting to resolve mixtures of compounds.

High performance liquid chromatography has become an efficient technique at the production scale, and simulated moving bed chromatography provides several benefits during processing.

The authors consider the advantages of using rapidly dissolving films to accurately and effectively deliver pharmaceutical ingredients, with an emphasis on the importance of controlling moisture content and drug loading during formulation development.

To date, calorimetry has not been given a fair trial in the PAT arena. Recent advances in reactor technology and design will ensure that real-time calorimetry is the present and future of PAT.

Recent regulatory initiatives have emphasized the need to improve pharmaceutical manufacturing. PAT marked the beginning of a number of regulatory efforts to encourage innovation and a transition towards science-based manufacturing. This article reviews the progress of the regulatory initiatives and describes two significant research initiatives to develop a future pharmaceutical manufacturing environment based on scientific understanding of pharmaceutical materials and processes.

Company and People Notes: Evotec and Renovis enter agreement, Amgen to lay off 675 workers, more.