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Pharmaceutical Stability: Scientific and Regulatory Considerations for Global Drug Development and CommercializationA two-day workshop on the "science behind pharmaceutical stability" was held in conjunction with the Annual Meeting of American Association of Pharmaceutical Scientists (AAPS) on Oct. 21-22, 2011 in Washington, DC.
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Oman pharma wins European approvalWhile the Gulf region has already become well-known for its globally accepted infrastructure, and large projects in tourism and other service areas, major investments in healthcare or pharmaceuticals have failed to develop as well.
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USP faces up to analytical realityWhen 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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Disposable bioreactors based on wave agitation technologyOver 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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A guide to EFPIA's Mock P.2 documentEFPIA'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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Dry powder inhalers: challenges and goals for next generation therapiesThere have been significant advances, especially in understanding the role of carrier properties on the aerosol performance of the API.
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PAT — a place for separation scienceWith appropriate standardization from an interfacing point of view, separation science will find a broader audience in PAT.
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20th Anniversary Special Feature: Robot remedies for pharma's fraught futureRobotization 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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The New Biopharmaceutical Blueprint: Service-Oriented Architecture in ManufacturingMore than ever, drug makers need to be fleet and flexible-and they need their software to be the same.
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A new system for the rapid transfer of sterile liquid through a containment wallSterile 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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Aspects of process development for virus vector production to improve quality and quantityThe 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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Keeping clean rooms compliantClean 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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Static electricity in solid dosage manufacturingThe 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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Particle design using fluidized hot melt granulationFluidized 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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A guide to EFPIA's Mock P.2 documentEFPIA'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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Practical guidelines for qualifying purified water systemsA 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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The Neglected Pharmaceutical Supply ChainsIncreased 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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Disposable bioreactors based on wave agitation technologyOver 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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Terahertz applications for the analysis of solid dosage formsThis 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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QbD for Drug Packaging and DeliveryWith 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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Monitoring processing-induced crystallinity changesThe 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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Preparing Requests for Quotations for Commercial Pharmaceutical ManufacturingBy following a step­by­step process for preparing a request for quotation, one can easily prepare a bid for outsourcing a project.
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Dissolution testing and good manufacturing practicesMissed 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 Formulation and Evaluation of Topical Berberine-Hydrochloride ProductsThe 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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How To Prevent Tablet Coating ProblemsEffective design of the tablet core and the coating process can help prevent film coating problems.
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IMS Limit Test Improves Cleaning Verification and Method DevelopmentA 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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Multimodal HPLC screening of polysaccharide-based chiral stationary phasesHigh-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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The Power Of X-Ray AnalysisX-ray powder diffraction (XRPD) is a versatile, non-destructive technique that reveals detailed information about pharmaceuticals.
