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Demystifying Complex Clinical Trial Kit PreparationBest practices can help ensure supply chain flexibility and viability for biologic drugs in clinical trials.
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Dissolvable Films: Dissolvable Films for Flexible Product Format in Drug DeliveryFor pediatric and geriatric patients, fast-dissolving drug-delivery systems provide an easier way to take medications and vitamins. Oral thin films have evolved to provide systemic delivery of active pharmaceutical ingredients for over-the-counter and soon, prescription drugs. The authors review the practical benefits of dissolvable films, their manufacture, and their market potential.
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Exploring Best Practice Tech Transfer Methods for CGTsBest practice methods for the tech transfer of CGTs can increase process and analytics robustness while remaining scalable.
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A Harmonized Approach to Performing a Risk-Based Audit Trail ReviewThe IQ Working Group has defined a pragmatic risk-based approach to audit trail review, where it is only required for high impact GxP data.
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Development of a Validated Method of Testing for NDMA in RanitidineThis article describes a validated method, using liquid chromatography/mass spectrometry, for detecting the carcinogenic impurity NDMA (N-nitrosodimethylamine) in ranitidine that meets and exceeds FDA’s limit of detection and limit of quantitation requirements.
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Is Collaboration the Key to Accelerating Biotherapeutic Development?Vendors are finding ways to address the increasingly complex analytical challenges in the biopharmaceutical industry to further biotherapeutic development.
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Evaluating the Impact of Fatty Alcohols on Permeation of Clotrimazole from Topical CreamsStudy results indicate that fatty alcohols may plausibly enhance the skin permeation of clotrimazole.
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Manufacturing Considerations for Sourcing GMP Fermentation ServicesThe authors describe the critical aspects of an ideal fermentation services provider.
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Characterization of the Performance of Bin Blenders-Part 3 of 3: Cohesive PowdersIn this final part of a series of three articles, the results from experiments involving cohesive materials are discussed in terms of mixing performance, agglomerate comminution, and lubrication of powder mixtures.
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Understanding the Variability in Bioburden Test Results in BiomanufacturingThis article explores the impact of test volume, microbial distribution, and dilution errors on bioburden testing variability. It presents statistical approaches to estimate percentage error and discusses strategies to optimize microbial enumeration techniques in biopharmaceutical quality control.
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Using Quality by Design to Develop Fixed-Dose Combination TabletsIn the present investigation, the fixed-dose combination (FDC) tablet of Atorvastatin calcium and Ezetimibe was prepared by a quality-by-design approach using two-level factorial design.
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New Year, Same Challenges: Pharma’s Ongoing Struggle with FDA 483sThe authors examine common FDA 483 findings and outline strategies to address and prevent regulatory non-compliance.
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Safe, Smart, and Sustainable Packaging for the Healthcare IndustryColbert Packaging specializes in safe, smart, and sustainable paperboard packaging for the pharmaceutical and healthcare industries, differentiating itself through industry-focused investments and a commitment to environmental responsibility.
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Polysorbates: Part(icle) of the Problem?A comparison between polysorbates and HPβCD determines the better stabilizer for biologics formulation.
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Reliance-Based Waivers Become the Predominant Trend in In-Country Testing of Pharmaceutical ProductsThis study reviews changes in in-country testing (registration testing, import testing) requirements and analyzes current trends. In the context of international harmonization of good practices and standards as well as the improved information exchange between national regulatory authorities, in-country testing is considered outdated and redundant in many cases.
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Master File Submission of StructuresThe SD File format offers benefits for KASA and cheminformatics to support regulatory submissions.
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A throughput benchmarking study of Supor™ Prime filters (July 2024)See how Supor Prime filters performed against two comparable products in filtering fluids with antibody concentrations of 70 g/L to 220 g/L. And be sure to request a sample!
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ICH Q6B for AnalyticsICH Q6B provides expectations and a clear framework for the structural characterization of biopharmaceutical products.
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2020 Bio/Pharma Virtual Congress*** Live: Wednesday, November 11, 2020 | 8:30 AM EDT – 4:00 PM EDT *** 2020 Bio/Pharma Virtual Congress: Join Pharmaceutical Technology® and BioPharm International® for this online event that will explore the latest developments in formulation, manufacturing, and innovative drug dosage forms, as well as detailed discussions about crucial topics impacting the industry. ***On demand available after final airing until 11/11/2021
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Determining Low PPB Levels of Nitrite in Polymeric ExcipientsIn this paper, the authors introduce a method that combines ion exchange chromatography with an easier-to-perform, simpler one-step post-column derivatization that is selective to nitrite and visible spectrophotometric detection to allow high sample loading volumes without affecting resolution.
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Use Of RFID Asset Management Systems For Monitoring Analytical InstrumentationUtilizing integrated active radio frequency identification (RFID) and real-time asset management systems can yield commercial and compliance benefits.
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Change management: common failures and a checklist for improvementThough the pharma industry has improved its change management processes, there are still opportunities for improvement.
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Integrated Approach Facilitates Inhalation Drug DevelopmentThe choice of delivery platform for inhaled drug products is contingent on API-related factors, as well as the development stage of the product.
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Viral Vector API Characterization of Product-Related ImpuritiesFDA’s final CMC guidance sets expectations for manufacturing and quality for human gene therapy INDs. This article reviews existing analytical applications, focusing on viral vector characterization of impurities.
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Application of the Risk Evaluation Matrix as per USP <665> and <1665> for Evaluation of Leachables Risk from Single-Use Components Used in BiomanufacturingDetermining E&L risk from single-use components can be used to build the level of extractable profiling and PERLs.
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Advancing Spray-Dried Dispersion Formulation DevelopmentIn-vitro and in-silico tools can help predict in-vivo outcomes for low-solubility drugs formulated as spray-dried dispersions.
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Drug Shortages and Complying with FDA’s 21 CFR 211.110 GuidanceSusan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Rona LeBlanc-Rivera, PhD, principal consultant, Regulatory Affairs at Regulatory Compliance Associates, answer some questions about FDA’s January 2025 21 CFR 211.110 guidance document.
