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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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Successful manufacturing of dry powder media from development to large-scale cGMP production: A two-phase strategy (May 2024)Read about the process utilized and results gained from the use of a two-phase scale-up strategy to manufacture three complex dry powder medium (DPM) formulations. The success of these projects relied on consistently producing acceptable prototype and cGMP material within the customer’s specifications and manufacturing timelines.
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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.
