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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.
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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.
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CPhI Worldwide 2017Latest:
Improving Content Uniformity of Morphologically Challenging APIs by Excipient ChoiceWebinar Date/Time: Tues Jan 14, 2025 11:00 AM EST
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Treating Halogenated Hydrocarbon Emissions from Pharmaceutical ProductionRegenerative thermal oxidation (RTO) has become a common solution to treat volatile organic compounds (VOC) and hazardous air pollutants (HAP) present in the emissions of many pharma production processes. Regenerative thermal oxidation devices used to treat halocarbons should be designed to prevent corrosion. Anguil Environmental Systems explains best practices for addressing potential fail points in the materials of construction when designing process emission handling systems.
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Avoiding Investigational Failure/Discrepancy-Related Form 483 ObservationsInvestigational failures and discrepancies can be avoided through the proper execution and documentation of investigations.
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Speeding Time to Market With Better Pharmaceutical Project ManagementElevating the project management function can improve transparency and enable companies to react faster to internal and external change.
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Understanding the Potential of Artificial Intelligence Across the Pharmaceutical LifecycleArtificial intelligence offers a number of opportunities in pharmaceutical drug development and manufacturing, but there are barriers to overcome, notably around how well and how quickly the regulatory environment can adapt and keep pace with to the rapid changes.
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A Continuous Improvement Metric for Pharmaceutical ManufacturingStatistical methods and novel indices can be used to monitor and benchmark variability, and guide continuous improvement programs in late-stage drug development.
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Lifecycle-Based Process Validation Emphasizes the Need for Continued Process VerificationA year’s worth of FDA warning letters suggest that API and finished drug manufacturers should strengthen their approach to continued process verification.
