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The Ever-Changing World of Extractables and Leachables: Lessons learned and future challengesOctober 4, 2021 at 3pm BST | 10am EST | 4pm CEST Join global industry and regulatory experts as they discuss current hot topics in extractables and leachables (E&L) testing for pharmaceuticals, biopharmaceuticals and medical devices.
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Drug Digest: Emerging Therapies In all Shapes and SizesThursday April 28, 2022 at 11am ET | 10am CT | 8am PT In this new video series, Drug Digest, the Pharmaceutical Technology editors examine the topic of emerging therapies in more detail, covering subjects such as the challenges of scale, the potential benefits of drug delivery innovation, importance of early analytical studies, the evolution of the regulatory landscape, and differences between regional regulatory requirements. Join the editors as they speak with experts from Regulatory Compliance Associates (RCA), the European Confederation of Pharmaceutical Entrepreneurs (EUCOPE), and others.
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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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Validating Single-Use SystemsThere are a number of validation approaches that can be adopted for single-use systems - all of which incorporate an established approach.
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Pharma Services Sector Poised for Continued Growth and ConsolidationThe CRO market will see greater consolidation by both financial buyers looking to consolidate smaller players and larger CRO players wanting to expand into value-added specialty service areas.
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Public Trust in Medicine Quality as Public Health Challenges EmergePublic health challenges have highlighted the need for agility in maintaining the quality of medicines.
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Implementing Data Integrity Compliance in a GLP Test FacilityConsider how to apply ALCOA+ to a building management system in non-clinical laboratories.
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Improving Aseptic Processing and Manufacturing NeedsWebinar Date/Time: Thursday, August 24th, 2023 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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Consultation on Proposals for the Future of UK Clinical Trial LegislationMHRA has opened a consultation on the proposed changes to clinical trial legislation in the UK.
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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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Accelerating Workforce Training on Single-Use TechnologiesTraining is crucial for supporting GMP operations in commercial-scale bioprocessing.
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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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Drug Product SecurityHigh-cost-per-dose large molecules can make a big impact on cell and gene therapy supply chain management.
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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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The Influence Of Superdisintegrants On Immediate ReleaseWhen it comes to immediate-release tablet formulations, the choice of disintegrant can have a significant effect on the rate and extent of drug dissolution.
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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.
