Authors
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Coating and Taste Masking with ShellacThe authors describe the background and applications of fully formulated aqueous shellac for film-coating systems.
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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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Setting Cleaning Validation Acceptance Limits for Topical FormulationsThere is a need for current cleaning validation methods to be used for topical formulations. The authors highlight the issues and challenges encountered.
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Pelletization: Revolutionizing Drug Formulation and DeliveryPelletization, a popular oral drug delivery method in pharmaceuticals and nutraceuticals, offers numerous benefits. This article delves into the critical parameters for formulation development and technological consideration in pelletization, elucidating its significance in advancing pharmaceutical solutions.
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Delivering added value in auto-injectors through strategic supply chain partnershipStevanato Group’s integrated offering addressing mAbs challenges includes Aidaptus®, a 2-step single-use auto-injector accommodating 1mL and 2.25mL PFSs in the same base device, supporting a range of drug viscosities for reliable delivery.
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Establishing a Framework for Reliable Pharma LabelingBy taking a strategic and evidence-based approach, companies can leverage the insights gained from stability studies to establish robust labeling.
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Coating and Taste Masking with ShellacThe authors describe the background and applications of fully formulated aqueous shellac for film-coating systems.
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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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Digital Transformation in Pharmaceutical ManufacturingLeveraging computerized maintenance management systems software can enhance efficiency, improve quality control, ensure accurate documentation, and strengthen data integrity.
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New Year, Same Challenges: Pharma’s Ongoing Struggle with FDA 483sThe authors examine common FDA 483 findings and outline strategies to address and prevent regulatory non-compliance.
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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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Dosage Form Compounding in the Workplace EnvironmentAn ordered pharmaceutical compounding process for use in 503A pharmacies, 503B outsourcing facilities, pharmaceutical industry, and other applications.
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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.
