Authors
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From Early Development to Commercialization: Strategies for Successful Cell Therapy ManufacturingDr Rupa Pike, Sr. Director & Global Head Strategic Alliances and Field Scientists for Cell Therapy, Catalent, shares insight on de-risking cell therapy programs using streamlined development and manufacturing platforms.
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Contamination Control for Cell and Gene Therapies Needs New AnalyticsAnalytical methods need a boost to ensure quality control for cell and gene therapies.
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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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The Evolution of Cell & Gene Therapy: Development and Manufacturing Insights and the Role of CDMOsDavid McErlane, Group President of Biologics, Catalent, reacts to trends in cell and gene therapy development and manufacturing and comments on Catalent's ESG strategy to support people, the environment, and communities.
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Harnessing cell line engineering capabilities to enhance biotherapeutic productsExplore the potential of next-generation genome editing tools for driving the success of monoclonal antibodies for biotherapeutics.
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Overcoming Challenges to Biopharmaceutical Development and Manufacture with Science- and Risk-Based StrategiesMany biologic drug manufacturers encounter similiar challenges; precompetitive collaboration can help resolve these issues. Representatives of the IQ Consortium’s Biologics CMC Leadership Group describe efforts to address the safe handling of biologic drugs in closed-system transfer devices in healthcare settings and the need for phase-appropriate specifications.
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Modified Release: A Pathway to More Patient-Friendly MedicationModified-release dosage forms present new opportunities for drug developers and can help overcome challenges, such as short biological half-life or poor bioavailability due to degradation in the stomach.
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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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Determination of Shelf-Life from Stability Data: From Replicates or from Averages?A statistical analysis for determining an expiration date can be applied to replicates or their corresponding averages as suggested in industry guidelines.
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Beyond GenAI: The Training-Free Discovery Potential of LLMs in a Drug Safety and Regulatory ContextLife sciences data sets can be vast and complex to process, but up to now bringing intelligent automation systems up to speed and validating them has felt debilitatingly onerous. Large language models tackle these barriers head on. Ramesh Ramani and RaviKanth Valigari, technology innovators at ArisGlobal, explain.
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Converging InformationTechnology & Automation TeamsGetting IT, engineering, and manufacturing on the same page requires a delicate balance.
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Thermogelling Matrix-Containing Platelet Lysate-Loaded Elastic Liposomes as a Potential Treatment of WoundsThe purpose of this article was to demonstrate the application of a new thermogelling matrix in the healing of wounds.
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An All-Round Excipient For Direct CompressionUsing new co-processing technologies, the authors show that it is possible to formulate an 'all-round' excipient.
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Staffing Shortages: Major Hurdle for Bioprocess Contract Manufacturing Services in 2023More than a third of CMOs are struggling to keep skilled technical and production staff.
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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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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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Delivering on the Potential of mRNA TherapeuticsThe complexity of the RNA production process creates challenges.
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Effective and Efficient Weighing of Potent CompoundsThe advantages of using an automated powder dispensing system in a ventilated balance enclosure for efficient handling and effective containment of potent compounds are discussed.
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Accelerating Workforce Training on Single-Use TechnologiesTraining is crucial for supporting GMP operations in commercial-scale bioprocessing.
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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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Patient Journey as a key to develop Inhalation combination products v3Discover why integrating Human Factors and patient activities from early device to manufacturing is essential to develop a patient-centric inhaler.
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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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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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Looking Beyond mRNA-based COVID-19 Vaccines to Innovative TherapeuticsmRNA technologies offer great promise in immunotherapy and non-immunogenic applications.
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Piramal Pharma Holds Groundbreaking at Kentucky Facility, Part of $90 Million Investment PlanThe expansion of the Kentucky site accounts for $80 million of the announced investment, with the remaining money earmarked for facilities in Michigan.
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Using Excipients In Powder FormulationsDuring the past few years, we've seen a growing interest in direct oral application products, evidenced by the large amount of products already available on the market.
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Process Performance as a Means of Quality ManagementProcess performance metrics of eight different mechanical devices were assessed to evaluate compliance with regulatory and compendial criteria.
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Harnessing Predictive Simulation to Improve MixingPredictive computational methods are finding wider use in pharmaceutical solid dosage development, particularly in mixing and blending, to improve tech transfer and equipment selection, and speed the acquisition of process understanding.
