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Driving Consistency in Validation ManagementWith data integrity regulatory violations on the rise, there is a need for better and more consistent validation management practices.
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Industry 1VQ Solutions: Replace Identity (ID) Testing of Incoming Liquid Drug Substance with ID by Visual VerificationA Post Approval Change (PAC) to replace identity (ID) testing of incoming liquid drug substance with ID by visual inspection is considered a low risk provided questioned listed in this example have been answered favorably. In that case the PAC can be downgraded from a prior approval to a notification to health authorities, and managed in the PQS with immediate implementation effect.
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An Alternative to the USP Disintegration Test for Orally Disintegrating TabletsThe authors propose an alternative to the USP disintegration test method. The method embraces physiological conditions of the oral cavity, as a screening tool for developing ODT products.
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Enhancing Process Validation for Sterile Liquid and Freeze-Dried Forms: Part 1AFI representatives of the process validation working group explore and define key elements for an enhanced approach to process validation for sterile liquid and freeze-dried forms.
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Extrapolating Data from Adult Clinical Trials to Advance Pediatric Drug DevelopmentExtrapolating data from adult clinical trials to a pediatric population is a proven method to avoid unnecessary pediatric clinical trials. Representatives of the Pediatric Working Group of the IQ Consortium share case studies that demonstrate how adult clinical trial data can be used to support the dose selection and regimen—or waive the need for a placebo control arm—for pediatric studies.
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The Future of Pharmaceutical Environmental Monitoring in EuropeA blended approach to newly revised regulatory guidance to inform environmental monitoring programmes is essential.
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Spray Drying as an Enabling Technology for Inhalation Drug DeliveryParticle performance in a DPI can be optimized by fine-tuning the formulation and manufacturing process parameters.
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Comparability in Accelerated or Stressed Stability Studies Using a Quality RangeA statistical procedure based on a quality range is proposed for demonstrating comparability between pre-change and post-change process slopes in an accelerated or stressed stability study.
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Computational Fluid Dynamics in Upstream Biopharma Manufacturing ProcessesAdvances in simulation and the development of digital twins.
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Antibody-Based Therapeutic Development Made EasyExpand your mAb NBE candidate pipeline numbers by leveraging ProtaGene's flexible analytical capacities. Get a complete overview of ProtaGene's end to end services.
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Advancing Oral Drug Development Using MIFDModel informed formulation development uses in-silico modeling and simulation to identify and/or refine promising formulations faster and cheaper, support formulation strategy and increasingly, demonstrate virtual bioequivalence and obtain biowaivers.
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Developing a Method to Learn Capper Settings to Handle Component VariationsOne of the causes of crimp variation that can lead to integrity failures due to poorly sealed vials has been reported to be component dimensional variation. Critical dimensions of the components of a vial system (vial, stopper, and cap) can vary within manufacturing tolerances, but these ranges of variation may require adjustments to the capper settings to ensure a proper package seal.
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Polymer Influence on the Rheological Properties of Co-Processed Microcrystalline Cellulose and Sodium CarboxymethylcelluloseIn this study, researchers evaluated the colloidal microcrystalline cellulose (cMCC) suspending agent—a co-processed material of microcrystalline cellulose and sodium carboxymethyl cellulose (NaCMC)—by using a representative pharmaceutical-grade commercial version of cMCC.
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Collaborative Efforts Address Key Data Integrity ChallengesMaintaining a quality culture across the diverse functions in a bio/pharmaceutical company is difficult. Representatives of the Quality Coordinating Committee of IQ Consortium report on collaborative efforts to address data integrity and the modernization of FDA’s good laboratory practice regulations.
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Optimizing Loss-in-Weight Feeding of Poorly Flowing MaterialsPrior to use in a continuous manufacturing system for oral solid dosage forms, loss-in-weight feeders need to be tested and validated to understand the performance capabilities of a given material–feeder combination. In this article, the proper strategy for set-up and optimization of a loss-in-weight feeder is demonstrated for a range of materials. The optimized set-up of the feeders was demonstrated to provide suitable performance for even the most challenging, poorly flowing materials.
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Formulation of Sustained-Release Ketorolac Tromethamine PelletsThe authors evaluated the effect of polymer composition on the drug-release profile and the effect of storage conditions on dissolution characteristics.
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Facing the Latest Patent CliffOver the course of the next five years, the bio/pharma industry is expected to see the patents of multiple blockbuster drugs expire, impacting some key industry players.
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Evaluating Okra Gum in a Floating Tablet Formulation as a Novel Drug Delivery SystemThe potential for okra gum as a polymer candidate for new oral drug formulations was evaluated.
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Determining Water Content with a Novel Karl Fischer Titration ApproachA new approach to testing water content in biologics is needed that will give a more accurate determination of actual water content in the biologic.
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Formulation of Modified Liquid-Solid Compact for Dissolution Enhancement of Raloxifene HydrochlorideThe purpose of this research was to formulate modified liquisolid compacts (MLSC) of RLX for improved dissolution in immediate-release tablet formulations.
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Inside USP: USP Metals Testing: A Workshop ReportAttendees at a recent workshop endorsed new methods to detect metals in drugs, dietary supplements, and food ingredients.
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Rapid Sterility Methods for CAR T-cell TherapiesA combination of rapid sterility methods with the industry standard compendial method should ensure maximum safety.
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Characterizing A Nasal Spray Formulation From Droplet To API Particle SizeThe way in which a suspension nasal spray product interacts with the body depends not only on the droplet size of the delivered droplet, but also on the particle size of the suspended API.
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A Four-Phased Approach for Evaluating a Quality Risk Management ActivityUsing the four-phased method to assess QRM can ensure continual improvement and that regulatory requirements are met.
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IVPT Data Analysis with FDA Statistical Approach to Assess BioequivalenceThis article describes the in-vitro permeation test study data processing procedures and FDA statistical mathematics of evaluating a generic topical drug product, acyclovir cream, against its reference product.
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The Ideal PharmacopeiaThis position paper describes a model for the future that would provide appropriate standardization, facilitate drug registration and support regulatory agencies.
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Do emerging markets provide the answer to the pharmaceutical industry?The emerging markets represent an attractive investment opportunity for the pharmaceutical industry because of the countries' growing economies and unmet medical needs.
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Digitalization of QbD Risk AssessmentsQuality-by-design risk assessment workflows can be laborious and have limited capacity to connect with vast volumes of prior knowledge generated by organizations. Their digital transformation can improve efficiency, reduce human errors, and facilitate integration within a much broader digital ecosystem.
