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Physical Nanoformulation for Solubility Enhancement of Poorly Soluble DrugsNano PharmaSolutions developed a new nanoformulation for improving solubility of drug molecules, which can save several months of preclinical stage of drug development.
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Selecting and Optimizing the Right Manufacturing PartnerOptimizing the use of partners for clinical trials depends on selecting the right contractor.
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FDA Grants Approval to Kedrion to Produce PLGD-1 Therapeutic at Bolognana PlantFDA's approval will allow Kedrion to manufacture Ryplazim (plasminogen, human-tvmh), the only FDA-approved therapy for treating PLGD-1, at facility in Bolognana, Italy.
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A Novel Cell Lysis Method to Improve the Viral Vector Manufacturing ProcessResearchers demonstrated a new cell lysis method using a novel solution to improve viral vector production.
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Variables Affecting Reconstitution Time of Dry Powder for InjectionThe authors describe the factors affecting reconstitution time of dry powder for injection and classifies them as intrinsic and extrinsic parameters.
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High-Quality Communication Enables High-Quality Drug ProductsUser fee programs have improved FDA’s approval timeline for important therapies.
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Accelerating Scientific Research Using the CloudThe “cloud lab” is a virtual laboratory setting that can enable scientists to more quickly advance research.
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Nitrosamine Impurities in Medicinal ProductsIndustry should improve the standards on application of risk management tools in light of the cases of nitrosamine impurities.
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Pharmaceutical Compounding Calculations in a Workplace EnvironmentAn ordered process describing calculations activities for compounded dosage forms is described.
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Addressing the complex demands of cell line developmentHaving a robust Cell Line Development (CLD) strategy is the foundation of biologic production that can propel a project, helping to streamline production while mitigating risk. A tailored and optimized cell line can be instrumental in overcoming development and manufacturing challenges and achieving a competitive advantage in the market with streamlined manufacturing processes. In this eBook, Bora Biologics describes how a robust CLD strategy can help biologics developers anticipate and overcome challenges and streamline production.
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Restructuring Method Transfer Through Global SitesMethod-transfer kits help simplify analytical method transfer for global site certifications.
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Fluid Pharma and Mikart Partnership: ODT microparticles improve acceptability in patients with DysphagiaSustained Release Orally Disintegrating Tablets (ODTs) Comprising Coated Microparticles to Improve Acceptability in Patients with Dysphagia
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The Global Regulatory VillageHarmonization of global regulations fosters innovation and ensures quality medicines.
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Design of an Aseptic Process SimulationThe authors suggest a design strategy for an aseptic process simulation that focuses on the basic repeating unit of the process, establishing alert and action criteria for the unit itself, and using worst-case simulations to establish routine operational parameters for the manufacturing process.
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Control Strategy: A Feedback-Feedforward ‘Controls Hub’ for Risk, Knowledge, and Product Lifecycle ManagementA control strategy can function as a powerful “hub” to gain a comprehensive understanding of the consolidated set of controls that are necessary to ensure consistent delivery of quality product.
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Overcoming Data Gaps in PharmacovigilanceBy leveraging certain strategies, organizations can effectively close data gaps and achieve more accurate and effective machine learning models in pharmacovigilance.
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STARMAP® Online: Empowering Therapeutic Development with Sparse-Data AILearn how STARMAP® Online cultivates an advantageous outlook for customers through accessible CESS®-powered nanoparticle technology. This platform can reduce the time, cost, and risk of drug development, as well as use AI to assure data privacy and streamline decision-making for patients.
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Michael J. Hennessy: MM&M 40 Under 40 AwardMichael J. Hennessy Jr., president and CEO of MJH Life Sciences™, parent company to Pharmaceutical Technology, named to MM&M’s second annual 40 Under 40 list.
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Mitigating Third-Party Risks: The Benefits of Extending Quality to the Supply ChainThe functionality of a digital quality management system (QMS) provides visibility into critical supplier activity and helps ensure a high-quality product.
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Assessment of Nanosuspension Formulation for Intranasal AdministrationResearch suggests that intranasal nanosuspensions offer a promising way to formulate and deliver drugs that are poorly soluble in water to patients with chronic conditions.
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Mitigating the Risk from Excipient VariabilityThis article reviews sources of excipient variability, including raw materials and processing, both of which may vary from supplier to supplier and from plant to plant for a single manufacturer.
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Using Novel Biomarkers to Facilitate AI-Driven GlycoproteomicsWith the evolution of scalability of peripheral blood protein glycosylation, research has expanded for new biomarkers.
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Risks and Rewards of Investing in RNA-based Genetic Medicine ManufacturingCollaboration is a key component to achieving long-term success with genetic medicines.
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Innovative Start-Ups at CPHI BarcelonaThe Start-Up Market at CPHI Barcelona will bring together 27 start-ups, innovators, and small enterprises from across the pharma landscape.
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Mitigating Pharmaceutical Production Risks Using Hot Water for Injection and Pure SteamWebinar Date/Time: Wed, Feb 7, 2024 10:30 AM CET (4:30 AM EST)
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Don’t Derail Drug Development: 5 Common Issues to Identify and Avoid With a First-Rate Quality ProcessWebinar Date/Time: Wed, Jun 14, 2023 11:00 AM EDT
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Continued Innovation is Key for COVID-19 RecoveryMore work is needed to educate businesses on the value of innovation and the availability of funding.
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Automated Vial Inspection for Maximum Product SafetyHow automated visual inspection monitors the packaging quality of vaccines
