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EPCAM: A Strategy to Enable Manufacturing-Process Control TransformationEnterprise process control and management (EPCAM) is a new strategy for healthcare manufacturers based on recent process-control breakthroughs in the electronics industry.
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Clinical And Cost Considerations Of Developing A BiosimilarBoth biosimilar and generic drugs have an abbreviated approval process; however, the clinical trial requirements differ enormously.
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Seven Trends Shaping the Future of Pharmaceutical Formulation DevelopmentEmerging new technologies and disruptive manufacturing concepts are providing new opportunities for pharmaceutical companies.
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Choosing the Right CDMO for CGT ProgramsWhether biologic manufacturers decide to outsource or develop products internally, the quality of a CDMO partnership is critical to success, especially for cell and gene therapy products.
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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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EPCAM: A Strategy to Enable Manufacturing-Process Control TransformationEnterprise process control and management (EPCAM) is a new strategy for healthcare manufacturers based on recent process-control breakthroughs in the electronics industry.
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Peer-Reviewed Technical Note: Influence of Common Excipients on the Crystalline Modification of Freeze-Dried MannitolMannitol is the most commonly used bulking agent in freeze-drying formulation design. The benefit of using mannitol is that it crystallizes during freezing and permits drying processes at higher product temperatures, and thus with higher sublimation rates relative to purely amorphous systems (1). Mannitol, however, is known to form different crystalline modifications which compromises reproducibility of product characteristics and storage stability due to phase transformations (2, 3).
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AST’s Aseptic Fill/Finish EquipmentAST’s VP of Business Development, Josh Russell, discusses the company’s impact on the pharmaceutical industry using innovative fill/finish equipment.
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Printable Medicines: A Microdosing Device For Producing Personalized MedicinesThe authors describe a new method for the production of personalised medicines utilising ultra-precise microdrop printing technology.
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Industry 1VQ Solutions: Change of Lot or Extension of Shelf-life of Reference StandardChange of lot or extension of reference standard shelf-life is considered low risk and should be downgraded from prior-approval to being managed in the Pharmaceutical Quality System (PQS) only based on a science and risk-based approach.
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Biologics Quality Control: The Growing Need for Accessible ProteomicsThere is a great need for sensitive, precise, and easily accessible analytical detection techniques for protein sequencing.
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Key Factors in the Development of Data Analytics for Industrial Pharmaceutical EquipmentDigital maintenance solutions can help visualize the value and key activities provided by the equipment vendor from inception to utilization.
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Considerations for Cleaning Lipid NanoparticlesThis article explores the concerns with cleaning pharmaceutical products utilizing LNP delivery vehicles and provides a general cleaning recommendation based on laboratory and field testing.
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Remdesivir interactions with sulphobutylether-β-cyclodextrinsThis paper presents results from an orthogonal study using isothermal titration calorimetry measurements and biased molecular dynamics simulations.
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Science and Technology of Bioadhesive-Based Targeted Oral Delivery SystemsNovel hydrophobic bioadhesive polymers and dosage designs are now available to effectively achieve tailored release kinetics of a broad range of drugs to meet the clinical needs.
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Seven Trends Shaping the Future of Pharmaceutical Formulation DevelopmentEmerging new technologies and disruptive manufacturing concepts are providing new opportunities for pharmaceutical companies.
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Chewable Tablets: A Review of Formulation ConsiderationsThis paper reviews considerations for the formulation of chewable tablets including sensory characteristics, chewability assessment, and drug release.
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When Is It Appropriate to Outsource Bioanalysis Work to a CRO?When considering whether to outsource work to a CRO, there are a number of factors to assess, including the type of work that may be outsourced, regulatory considerations, and needs for the study.
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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: US Pharmacopeia Guideline for Pending MonographsUSP's guideline for pending monographs can speed up publication of monograhs and time to market.
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Handling Challenging Powders in Tableting OperationsTests evaluated commercial rotary tablet presses to see how effectively they deal with problems such as poor flow, overlubrication, and capping.
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Using Modified QbD to Develop a Novel Pediatric Formulation of EzogabineThe epilepsy treatment, Potiga, has been used off-label to treat specific types of epilepsy in some children. However, it has never been formally evaluated in pediatric clinical trials. Using a modified QbD approach, the authors have developed a granular formulation suitable for use in clinical trials involving infants and children.
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Toxicology: Guaranteeing Drugs are Safe for PeopleAccelerated drug development timelines must accommodate all crucial elements of nonclinical safety studies.
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Enabling the Virtual Human Through Physiologically-based Pharmacokinetic ModelingBasic principles of physiologically-based pharmacokinetic (PBPK) modeling and its impact in streamlining the drug development process are reviewed.
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Is There A Need For Stringent Regulations For Excipients?Excipients should be regulated to manage risk. Although, excipients are an integral part of a finished pharmaceutical product, the issue of regulation is complex.
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Inside USP: Metrology and USP DissolutionThe United States Pharmacopeia emphasizes mechanical calibration and a performance test to esnure integrity of the dissolution procedure.
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Patentability Considerations for Antibody-Related InventionsStringent patentability requirements present a challenge to obtaining broad-based antibody claims, so companies should develop a strategy based on multiple reinforcing layers of protection.
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The Marriage of RNA and Mass SpectrometryConsiderable efforts have been made over the years to resolve the key issues of stability and delivery of RNA-based therapeutics.
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Planning for Success: Navigating Regulatory Strategy and Design Verification for Combination ProductsWebinar Date/Time: Wed, Sep 18, 2024 11:00 AM EDT
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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.
