Authors
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Extractables and Leachables Testing for Inhaled MedicinesFollow guidelines for E&L studies of an orally inhaled and nasal drug product formulation in its delivery device.
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Stage 2 Process Validation: Regulatory Expectations and Approaches to Determine and Justify the Number of PPQ BatchesThe authors summarize the current regulatory expectations regarding the number of PPQ batches required and provide potential approaches that can be used to determine and justify the number of PPQ batches.
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Overcoming Concerns to Adopting Continuous ProcessesDespite the benefits of continuous processing adoption has been slow, except for a few process areas.
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Working Smarter: Establishing an Effective Serialization ArchitectureThe author shares his opinion on the challenges presented by the Internet of Things and what companies need to consider when choosing suitable architectures to manage serialization data.
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Drug Spending Not Driving Rising Health Care CostsNew reports indicate that drug prices are slowing compared to other healthcare costs.
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Analysis of Sub-Visible ParticlesNovel analytical methods may help biologics manufacturers respond to stricter regulations on particulate matter.
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Patheon OneSource™Patheon OneSource™ helps small and emerging pharmaceutical companies lower risk and drive more predictable outcomes by integrating drug substance and drug product development decisions within a single CDMO.
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Construction Approach of a Phosgenation Laboratory and GMP Plant at ValsyntheseThe author describes the construction approach of a phosgene R&D laboratory and a medium-scale commercial phosgenation plant at Valsynthese.
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FDA Perspectives: Understanding Challenges to Quality by DesignDirectors from FDA's Center for Drug Evaluation and Research summarize findings in an FDA-commissioned report on QbD and propose actions the agency can take to encourage full-scale QbD implementation.
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The Fine Chemicals MarketThe increased trend of outsourcing coupled with a relatively strong economy has seen the fine chemicals market grow at a very high level when compared to historical data.
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Enhancing API Solubility During API Processing and Formulation Development MilliporeSigmaUnderstanding the impact of API solubility on the performance of a given drug product and determining ways to enhance dissolution rates is critical to ensuring your product makes it to market, into the hands of patients and clinicians, is well absorbed and provides its intended therapeutic effect. Selecting the best formulation strategy to address challenges for each API, however, can be time-consuming, costly and complex.
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ABITEC CorporationABITEC is a global leader in the development and manufacture of specialty lipids and surfactants. Through our world-class technical, scientific, regulatory and manufacturing expertise, we deliver the highest quality solutions in solubilisation, emulsification, and lubrication. Our mission is to develop and manufacture functional lipids to meet and exceed the application demands of the Pharmaceutical, Nutritional, and Specialty Chemical industries.
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Coatings Sweeten Pharma Tablet ProductionMaterials and equipment innovations have advanced tablet coating from sugar to copolymers and simplified pharma production.
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A 30-Year History of PLG Applications in Parenteral Controlled Drug ReleasePoly(lactide-glycolide) has been used for drug-delivery applications because of its beneficial physicochemical properties, long safety record, and reliable commercial supply.
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History Guides Future CMO StrategiesAs pharma models changed during the past 40 years, contract manufacturing capacity and services evolved to meet demand.
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The Commitment ContinuesPharmaceutical Technology marks 40 years covering the bio/pharma industry.
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Analysis of Total and Transferrin-Bound Iron from Serum SamplesIncorporating structural constraints into pharmacokinetic studies of iron sucrose formulations.
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Analysis of Total and Transferrin-Bound Iron from Serum SamplesIncorporating structural constraints into pharmacokinetic studies of iron sucrose formulations.
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Determining Protein Oxidation Induced During Fill-Finish OperationsThe effect of absorbed vapor-phase hydrogen peroxide on a lyophilized product Protein Z, was studied by spiking experiments with different amounts of hydrogen peroxide.
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Maxims of Electronic Records IntegrityManaging and controlling e-records is vital for maintaining CGMP data integrity.
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Determination of Eight Nitrosamine ImpuritiesThis application note demonstrates that the Agilent 6475 triple quadrupole LC/MS system can confidently quantify nitrosamine impurities at the low concentration levels specified by regulatory requirements. This method can be used to quantify these impurities in different ARB drug products, with some changes in chromatographic conditions based on the elution pattern of the drug product.
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Want Faster and Cheaper with Higher Quality? Get it Right the First TimeWeak or faulty quality systems can hurt a company at every stage of a product’s lifecycle.
