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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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From the Chairman: Technology Advances Foster New TherapiesTechnology advances foster new therapies.
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Inside Experic: Revolutionizing CDMO & Clinical Packaging ServicesDave Wood, CEO at Experic, discusses how decades of expertise with advanced technologies helps pharmaceutical and biotech partners bring products to market faster.
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Developing an Optimized Risk Assessment Portfolio—The Quality Risk Management Master PlanA thoughtfully constructed QRM Master Plan translates the strategy and enables a risk-based approach.
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Are You Ready for REMS?A book offers a detailed introduction to the new area of risk evaluation and mitigation strategies.
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Analytical Strategies for Cell and Gene Therapy DevelopmentDeveloping bioassay methods requires a new approach for cell and gene therapy drug development.
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Liposome ExtrudersLiposome extruders are mainly used for the liposome formulation and achieving uniform size distributions. It is an ideal instrument to generate nanoscale liposome formulations, and to prepare exosomes and artificial cell membranes. By utilizing the tracked-etched filter membranes, the liposome extruders are capable
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Outsourcing: The Indian PerspectiveIndia has evolved from a low-cost region to an area with extensive technical capability and high quality standards.
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The Benefits and Challenges of PEGylating Small MoleculesPolyethylene glycol (PEG) conjugation is a highly effective technical and commercial strategy to develop macromolecules. The authors explain the benefits and process of PEGylation and how it may be applied to small molecules.
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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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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, Part One–Non-Salts, Salts, and Policy-Exception SaltsCalculating the amount of drug needed for compounding requires different considerations for respective drug types and forms.
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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.
