Authors
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Leveraging Integrated Patient-Centric Innovations When Developing Today’s BiologicsHeidi Casaletto, Vice President of Global Marketing, Catalent, comments on the significance of developing biologics with a 'patient first' philosphy.
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Recent Options for Phase 1 Formulation Development and Clinical Trial Material SupplyTo meet the demands of early-stage development, contract research organizations can evaluate various dosage-form options. The author examines various methods of capsule filling, including binary blends.
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Suitability-for-Use Considerations for Prefilled SyringesThe nature of their application and their mode of use mean that prefilled syringes meet the regulatory definitions of immediate packaging or container–closure systems.
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Ongoing Analytical Procedure Performance Verification—Stage 3 of USP<1220>Analytical procedure performance can be continually verified by risk-based monitoring of performance related data.
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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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Inside Lonza CHI’s Innovation Engine: Future-Ready Capsules for Complex DrugsHow Lonza Capsules & Health Ingredients (CHI) is redefining drug delivery with cutting-edge capsule innovation, customer-first service, and a strong commitment to sustainability
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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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Quality, Resilience, and Reinvention in Pharma ManufacturingThe pharma industry is focused on strengthening its foundation, embracing innovation, and future-proofing its path forward.
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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.
