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When the United States Pharmacopeia (USP) announced a delay to the proposed implementation date of July 2007 for General Chapter <467> Residual Solvents, pharmaceutical companies supplying the US market welcomed the interim reprieve. However, meeting the new implementation date will prove challenging as the requirement applies to all existing products covered by the USP and companies must still work hard to prepare for July 2008 when <467> will finally come in.

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Over the past decade, disposable technologies have become a reality in biotech processes. The use of disposables in research and manufacturing allows high flexibility.

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EFPIA's 'Mock P.2' document aims to show how the role of 'quality risk management' and process analytical technology as an enabler for quality by design can be presented in a common technical document format. This article summarizes the main features of this document, and explains the key concepts and principles used.

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There have been significant advances, especially in understanding the role of carrier properties on the aerosol performance of the API.

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With appropriate standardization from an interfacing point of view, separation science will find a broader audience in PAT.

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Robotization of end-of-line packaging systems enables manufacturers to maintain high production rates while accommodating flexible and varied product packaging requirements.

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More than ever, drug makers need to be fleet and flexible-and they need their software to be the same.

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Sterile liquids are frequently transferred during the processing of sterile liquid drugs such as injectables or ophthalmic drops. Several types of transfer can be performed, each requiring a validated method to ensure the desired sterility-assurance levels are achieved.

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The use of viral vectors as gene delivery and vaccine vehicles has developed rapidly during the last two decades owing to several viral properties. Viruses can infect cells efficiently, often have a broad tissue tropism and can achieve very high levels of either stable or transient transgene expression. Furthermore, their intrinsic immune-stimulatory properties can have adjuvant effects during the treatment of cancer or infectious disease and, importantly for manufacturing scale-up, some viruses can be grown to very high titre (.1012 particles/mL). The development of robust production procedures is essential to move therapeutics that utilize viral vectors into clinical trials, and to make them cost effective for market supply. Here, we describe some of the aspects of production that must be considered and optimized when producing virus vectors on an intermediate or large scale. By drawing examples from our experience of vector production, we show that upstream and downstream processes must be designed..

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Clean rooms are critical areas in bio/pharma facilities, and it is essential that users are responsible for their care and upkeep, and familiarize themselves with the relevant regulations.

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The same phenomena that create lightning and thunderstorms are around us every day, producing incredibly high voltages, which cause sparks and shocks. Static electricity is a mighty force. Each year excessive electrical charge build cause explosions in the grain industry.1 Look around any flammable storage area and you will see both grounding bars on the wall and cables, from the grounding bars connected to the drums of solvents. Take any material safety data sheet (MSDS) for a powder and look in section V; it highlights that any dry powder has the potential to attract and store a charge.

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Fluidized hot melt granulation (FHMG) is an emerging technique combining the advantages of both dry and wet granulation methods, and represents an innovative continuous granulation process capable of mixing and agglomerating excipients and active pharmaceutical ingredients (APIs) to produce uniform blends of particles suitable for use in the manufacture of pharmaceutically elegant solid dosage forms.

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EFPIA's 'Mock P.2' document aims to show how the role of 'quality risk management' and process analytical technology as an enabler for quality by design can be presented in a common technical document format. This article summarizes the main features of this document, and explains the key concepts and principles used.

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A well-devised QPP, which has been agreed on and signed by both parties, saves time and makes it easier to complete activities such as design, installations and tests.

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Increased competition, industry consolidation and proliferation of products are just a small number of factors putting pressure on pharmaceutical companies to change their traditional business methods. There is a growing focus on improving supply chain efficiencies as a means of optimizing operating margins and financial performance. This article outlines three supply chain types, all of which are identifiable by their product delivery time requirements, which may help pharmaceutical companies streamline supply chain processes and reduce costs.

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Over the past decade, disposable technologies have become a reality in biotech processes. The use of disposables in research and manufacturing allows high flexibility.

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This article investigates pharmaceutical applications of terahertz technology, specifically using techniques for solid dosage form analysis such as pulsed spectroscopy (to generate physical information and detect API changes) and pulsed imaging (to locate formulation impurities, and regulate tablet coating quality and thickness).

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With most biologics in development taking injectable form, drug makers are increasingly exploring the use of prefillable syringe and self-injection systems for their administration; the adoption of QbD principles helps to ensure that components are engineered with stringent and specialized needs in mind.

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The crystalline structure of pharmaceutical solids can sometimes be altered during processing. X-ray powder diffraction and near infrared spectroscopy can be used to determine the amorphous and crystalline content of a model substance. The two techniques' precision, accuracy, detection limit and the speed of analysis are compared.

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By following a step&#173by&#173step process for preparing a request for quotation, one can easily prepare a bid for outsourcing a project.

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Missed or late calibration dates can accumulate, and even if the equipment is labelled appropriately, it can suggest poor management of resources and priorities.

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The authors sought to prepare a topical formulation of berberine hydrochloride for the effective and controlled management of inflammation and skin infections.

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Effective design of the tablet core and the coating process can help prevent film coating problems.

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A limit test using ion mobility spectrometry (IMS) has the potential to dramatically reduce the time required for cleaning verification and cleaning method development. The traditional approach to cleaning verification, often using HPLC, is relatively resource intensive and can lead to significant delays in reporting results. The main advantage of IMS is that results are seen virtually instantaneously, so any necessary re-measurement can be done very quickly. If the results demonstrate cleanliness, production can resume in a matter of hours not days.

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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.

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X-ray powder diffraction (XRPD) is a versatile, non-destructive technique that reveals detailed information about pharmaceuticals.

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Raman spectroscopy has become a commonly used technique for physicochemical analysis that possesses many advantages over other analytical techniques. It is a very attractive characterization tool, not least because it enables measurements in water. However, very few examples of its application in an aqueous environment exist in literature. This paper provides some recent applications of Raman spectroscopy in pharmaceutical material and process characterization when water is present.

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Virus safety of biotech- and plasma-derived therapeutics is ensured through complementary manufacturing and quality control measures that include the control and monitoring of raw materials, the validation and implementation of effective virus clearance technology and the monitoring of final filled product for the presence of virus. Virus filtration, which is considered a robust and effective virus clearance technology, is a common unit operation in the manufacture of biologicals. In this article, we review the points that must be considered when selecting a virus-retentive filter. The areas covered include regulatory considerations; selecting, optimizing and validating a virus filtration step; and process scale implementation - areas that are critical to users of virus filters.