Authors
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Transformations in Drug Development for Cell and Gene TherapiesAs a recognized leader in immunophenotyping for clinical trials, Kevin Lang from PPD discusses how spectral flow cytometry is transforming drug development, particularly in cell and gene therapies like CAR-T. He also dives into his award-winning research, including his 2024 WRIB Poster Award-winning work, and his insights from presenting at AAPS PharmSci360.
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GMPs for Method Validation in Early Development: An Industry Perspective (Part II)IQ Consortium representatives explore industry approaches for applying GMPs in early development.
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Early Development GMPs for Drug-Product Manufacturing of Small Molecules: An Industry Perspective (Part III)IQ Consortium representatives explore industry approaches and practices for applying GMPs in early development.
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Mitigating the Risk from Excipient VariabilityThis article reviews sources of excipient variability, including raw materials and processing, both of which may vary from supplier to supplier and from plant to plant for a single manufacturer.
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Mitigating Risk for Single-Use Assemblies in Sterile FillingRisks associated with single-use technologies, such as product loss and sterility assurance, are magnified in the filling operation because of its closeness to the product in its final form. A thorough evaluation of the assembly design process, manufacture, and use can assist in identifying and mitigating these risks.
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Validation of a Clean-in-Place System on a Capsule Filling MachineThe aim of this study was to validate the automated clean-in-place (CIP) system installed on a capsule filling machine to determine its ability to adequately eliminate contaminants. The results obtained from the proposed cleaning validation trial showed that all the soluble tracer was removed after the washing procedure. At the end of the CIP procedure, the discharged water had the same pH, phosphate content and total organic content as the supplied water. Lack of cross-contamination in the product was also demonstrated and a recovery trial highlighted the complete elimination of the tracer from the machine.
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Best Practices for Restricted Access Barrier SystemsRestricted access barrier systems (RABS) maximize product control but minimize operator interaction in aseptic manufacturing.
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Rebranding Lipophilic ExcipientsSolubilizers play an important role in dissolving poorly soluble molecules. As the number of poorly soluble lipophilic and/or hydrophobic molecules increases-whether as "brick dusts" or waxy substances-the industry is struggling to identify the appropriate lipophilic excipients (surfactants, solubilizers, solvents or polymers) that can be used to develop such poorly soluble formulations into solid dosages and other forms of pharmaceutical products.
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Early Development GMPs for Drug-Product Manufacturing of Small Molecules: An Industry Perspective (Part III)IQ Consortium representatives explore industry approaches and practices for applying GMPs in early development.
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Live Report From ACHEMAWith ACHEMA entering its penultimate day and many visitors preparing to return home after a busy stay in Frankfurt, PTE editor Jo Watts gives her closing thoughts on the show.
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A Real-World Approach to Evaluating Cleanroom GarmentsTraditional methods of testing cleanroom garments fail to test for dynamic conditions in the cleanroom. A holistic approach considers particulate shedding and heat load during processing, as well as the impact of laundering on garment life cycle.
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FDA and the Importance of ConfidentialityRecent news stories have reported that FDA scientists have been suspected of leaking confidential, commercial, and trade secret information to the media.
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Rebranding Lipophilic ExcipientsSolubilizers play an important role in dissolving poorly soluble molecules. As the number of poorly soluble lipophilic and/or hydrophobic molecules increases-whether as "brick dusts" or waxy substances-the industry is struggling to identify the appropriate lipophilic excipients (surfactants, solubilizers, solvents or polymers) that can be used to develop such poorly soluble formulations into solid dosages and other forms of pharmaceutical products.
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Dessicants for Pharmaceutical ApplicationsThis article examines the different types of dessicants avaliable to the pharmaceutical industry. It provides information on choosing the right type, and how and when it should be used.
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Saving the Next Generation of Regulatory ScientistsNew educational programs are key to the industry's future and to safe, available drugs.
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GMPs for Method Validation in Early Development: An Industry Perspective (Part II)IQ Consortium representatives explore industry approaches for applying GMPs in early development.
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Tools for Enabling Process Analytical Technology Applications in BiotechnologyIn this paper, the authors review the various analytical methods that can enable use of PAT.
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Pan Coating and Scale-Up: a Practical Guide Based on First PrinciplesThere are various theories about how to scale up a solid dosage coating operation in a pan coater. This article provides a basic process understanding and scale-up theory based on first principles.
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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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Is Pharma Getting the Best out of Social Media?With social media receiving increased focus as the pharma industry strives to make the most of new communication technologies, we speak with Cognizant?s Bhaskar Sambasivan to find out where pharma is when it comes to social media implementation and what more should be being done.
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GMPs for Method Validation in Early Development: An Industry Perspective (Part II)IQ Consortium representatives explore industry approaches for applying GMPs in early development.
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Changing Demand For Modular CleanroomsA modular cleanroom construction is typically a freestanding, solid and robust structure that is suitable for use within an existing cleanroom, laboratory, manufacturing area or warehouse.
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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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The Validation and Implementation of a Chromatography Data SystemThis article describes the approach used to upgrade a chromatography data system. The upgrade was required to meet the current regulatory requirements for good laboratory and good manufacturing practice. Compliance with 21 CFR Part 11 for electronic records and electronic signatures was also a major consideration. The procedures used for this project followed the software development life cycle (SDLC) and involved the co-ordination of personnel from the software vendor, the user department, information technology and quality assurance.
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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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How to Manage Effective Leadership when Change is the Only ConstantA disciplined approach to changing behavior can achieve change agility.
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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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Energy Conservation in Pharmaceutical ManufacturingThe authors discuss opportunities for energy efficiency in pharmaceutical manufacturing.
