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Variable Air Velocity within Stability Chambers A Possible Cause of Out-of-Trend Stability ResultsStability data that do not follow the expected trend in comparison with other stability batches or previous results collected during a stability study are considered out-of-trend (OOT) results. OOT stability results recently have gained the attention of regulatory agencies and as a result, the approach for identifying and investigating OOT results has become a topic of increased discussion. One example is a 2003 article by the PhRMA Chemistry, Manufacturing, and Controls Statistics and Stability Expert Teams, which was intended to initiate dialogue on how to address OOT results (1).
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What Does Drug Packaging Tell Us About its Contents?The content and quality of information supplied with drug products are among the most specifically defined areas associated with the products for sale. For patient or drug user, the information is presented in patient information leaflets (PILs) placed in the package. The readability testing of PILs is an important stage in the process of making the texts contained in the summary of product characteristics comprehensible to users, as this article discusses.
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Part VII GMPs for Small Molecule Drugs in Early Development Workshop SummaryThe authors explore and define common industry approaches and practices when applying GMPs in early development.
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Atomic Force MicroscopyAn analytical technique that is receiving increased attention in the pharmaceutical industry is atomic force microscopy. We interview Mark Leaper from the UK's De Montfort University to find out more about this technology.
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Mapping Sensor Placement and NumbersThis Rotronic Technical Note covers the basics of how to choose the correct number of sensors and where to place them for a proper cGMP mapping study.
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Retirement for Obsolete Heavy Metals TestsThis article discusses the retiring of Ph. Eur. and USP heavy metal assays as well as a means of updating related specifications with minimal regulatory burden.
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Designing a Clean-in-Place SystemAn efficient cleaning cycle begins with equipment and automation-system design.
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Solutol HS15 as a Novel ExcipientThe authors present an update to the Wyeth/BASF experience with the IPEC Novel Excipient Safety Evaluation Procedure.
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Designing a Clean-in-Place SystemAn efficient cleaning cycle begins with equipment and automation-system design.
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USP Publishes Monoclonal Antibody GuidelinesA General Chapter on mAbs will be published in USP-NF as biologics increase their role in healthcare.
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Risk-Sharing Agreements in the EU and Considerations for Moving ForwardThe authors look at key factors driving the risk-sharing agreements that have been implemented to reduce drug expenditures across Europe.
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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.
