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Laboratory Equipment QualificationA summary of the conclusions of the PhRMA Workshop on Acceptable Analytical Practices describes equipment qualification practices and guidelines that are designed to help the pharmaceutical industry be consistent in meeting core requirements.
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The Impact of Automation on Aseptic ProcessingThe authors review the role of automation in aseptic processing and describe their experience in implementing advanced technologies, including the use of isolators and robotics.
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Monitoring Granulation Drying Using Near-Infrared SpectroscopyA novel probe design that reduces the variation in powder-sample density also allows moisture and solvent levels to be accurately modelled and predicted...
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Tackling waste water with nanofiltration membranesThe pharmaceutical industry must address the release of nonbiodegradable APIs into the environment.
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USP's Semi-Hemiquinquennial MeetingA recent USP gathering generated creative suggestions for the March 2005 USP convocation.
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Elevating laboratory informatics to assist decision-makingWith pressure to cut costs, shorten the pipeline life cycle and maximize return on investment, pharmaceutical manufacturers need tools that help them improve enterprise-wide communications, reach critical decisions faster and produce timely, accurate reports on how compounds are progressing.
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Dissolution Testing For Inhaled DrugsAlthough there are no regulatory requirements or established pharmacopoeial techniques for the dissolution testing of inhaled drugs, such testing can potentially open up the opportunity to tailor formulation properties.
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The African Markets Pharma Can’t IgnoreIn its new study on pharma market growth in Africa, IMS Health highlights three ‘rising star’ countries from the continent’s sub-Saharan region.
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The challenge of 21st century influenzaConventional influenza vaccines use an egg-based culture and harvest process. This is slow and inflexible compared with emerging cell culture-based approaches that respond rapidly to the influenza virus's inherent ability to 'drift' or, more dangerously, 'shift' - a critical factor that would arise in the event of a pandemic.
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Drinking from a fire hoseThe pharmaceutical industry is facing the perfect storm. Increasing healthcare costs, a changing regulatory environment and vigorous global competition coupled with the increasing complexity of small molecule and biotech drugs contributing to expensive discovery processes and clinical trials, as well as the resultant manufacturing challenges, all pose major threats to the industry.
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Enhanced brain drug delivery and targetingThe blood–brain barrier (BBB) forms an interface between the circulating blood and the brain, and functions as a tremendously effective barrier for the delivery of potential neurotherapeutics into the brain parenchyma. Conversely, the BBB possesses various carrier-mediated transport systems for the uptake of small molecules, such as essential nutrients and vitamins. These transporters have become an attractive target for drug/prodrug design in an attempt to ferry drug molecules across the BBB. Central nervous system (CNS) drug delivery is often limited by poor brain penetration of the potential drug candidate. As a result of its unique barrier properties, the BBB poses a huge challenge for the delivery of potential neurotherapeutics into the brain parenchyma.1 It is estimated that only 2% of small-molecule drugs and ,0.1% of novel protein and peptide pharmaceuticals developed for CNS diseases reach therapeutic concentrations in the brain.2,3 Many of the pharmacologically active drugs tend to fail..
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Outsourcing still the way forwardDuring the past two decades, outsourcing has become increasingly prevalent as the way to gain competitive advantage. This trend has led to a significant increase in the number of services and functions available for outsourcing, and there are emerging opportunities for niche outsourcing to contractors that provide specialized sets of tools and access to cutting-edge technology.
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Creating PVA copolymer capsulesWhen drugs are encapsulated, electrification (the electrostatic charge of the capsule) may sometimes cause problems, such as capsule adhesion during transportation or dispersion of the capsule content in the filling process.
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EC Reviews: An Executive Country Review on TurkeyIn the wake of economic growth, healthcare reforms, and large-scale industry investment, Turkish pharmaceutical companies are charting their own destiny.
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Information-Technology Criteria in CMO Selection and ManagementA sponsor company must investigate the manufacturing automation and systems, laboratory automation and systems, information-technology infrastructure, and business applications of each potential contract manufacturing organization.
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Changes to Vial Labels May Affect Patient SafetyUSP's revised chapter on injectables could harm anticounterfeiting efforts and drug administration.
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The new biopharmaceutical blueprintAs a skipping stone creates ripples in a lake, SOA can help create benefits that quickly ripple through many other areas of the organization and partners.
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Pushing for allergen labellingThe biggest benefit that has been brought about by the compulsory labelling of allergens in food is the greater degree of cooperation that has been established between food manufacturers and their suppliers.
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Using a Delphi Survey to Assess the Value of Pharmaceutical Process Validation Part II: Expert OpinionsEuropean expert opinions regarding pharmaceutical process validation were collected and studied by performing an Internet Delphi survey. In total, 36 experts from 10 countries representing the pharmaceutical fields of industry, regulation and academia participated in the survey. The overall attitude to process validation appeared to be positive; however, a number of concerns were raised. More education, better use of prioritizing tools and increased evidence of cost-effectiveness is needed to further develop and facilitate process validation.
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Current status in buccal drug deliveryThe adequate absorption and transport of drugs in the body is part of optimal therapy. Drug administration perorally is easy, common and traditional, but occasionally alternative routes are required.
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EC Reviews: An Executive Country Review on TurkeyIn the wake of economic growth, healthcare reforms, and large-scale industry investment, Turkish pharmaceutical companies are charting their own destiny.
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Packing-Line Improvement Based on a Fault-Tree Analysis ApproachThis article focuses on upgrading and improving a packing process to comply with current good manufacturing practices. The authors sought to maintain proper quality assurance for finished products.
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A detail often overlooked: goggles in aseptic productionHood, suit, faceplate, cover shoes, gloves: these are the necessary items of clothing when operating in A-and B-grade areas.
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Improved Mass Determination of Poly(ethylene glycols) by Electrospray Ion-Mobility Time-of-Flight Mass Spectrometry Coupled with Ion–Molecule ReactionsThe authors developed a method to accurately measure the average molecular weight of large poly(ethylene glycols) (PEGs) using ion-mobility time-of-flight mass spectrometry coupled with gas-phase ion–molecule reactions.
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Out of Africa: the pharma challengeManufacturing facilities must be inspected by members of regulatory bodies. However… these bodies are woefully inadequate at performing the task.
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20th Anniversary Special Feature: The time for process understandingWhen Pharmaceutical Technology Europe was established 20 years ago, PAT was not a hot topic in the industry. It was started in 2002 by FDA to modernize pharmaceutical manufacturing and increase the efficiency of manufacturing processes.
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Tackling waste water with nanofiltration membranesThe pharmaceutical industry must address the release of nonbiodegradable APIs into the environment.
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Narrowing the gap between clinical capsule formulations and commercial film-coated tabletsBased on formulation simplicity and blinding capability, hard gelatin capsules are preferrable compared with other oral solid dosage forms, including tablets, in the early clinical phases of drug development.
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Identification of Fungi Using Ribosomal Internal Transcribed Space DNA SequencesIdentification of fungi, especially filamentous fungi, has been a very difficult task. Because of the amount of experience required to accurately identify filamentous fungi to the species level, it has become acceptable to either identify these organisms to the genus level or, in some cases, simply identify them as "molds."
