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Is There A Need For Stringent Regulations For Excipients?Excipients should be regulated to manage risk. Although, excipients are an integral part of a finished pharmaceutical product, the issue of regulation is complex.
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Inside USP: Metrology and USP DissolutionThe United States Pharmacopeia emphasizes mechanical calibration and a performance test to esnure integrity of the dissolution procedure.
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Patentability Considerations for Antibody-Related InventionsStringent patentability requirements present a challenge to obtaining broad-based antibody claims, so companies should develop a strategy based on multiple reinforcing layers of protection.
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The Marriage of RNA and Mass SpectrometryConsiderable efforts have been made over the years to resolve the key issues of stability and delivery of RNA-based therapeutics.
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Planning for Success: Navigating Regulatory Strategy and Design Verification for Combination ProductsWebinar Date/Time: Wed, Sep 18, 2024 11:00 AM EDT
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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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Considerations for Method ValidationSusan J. Schniepp, distinguished fellow for Regulatory Compliance Associates, and Shiri Hechter, senior lab operations manager for Nelson Laboratories, provide a simple approach to validating analytical methods.
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Launching And Commercializing BiosimilarsMany hurdles lie between a biosimilar and success on the market. In particular, there are three main questions that companies will be asking themselves.
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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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At the Heart of Pharma: ESG has Arrived as a Central StrategyPharma supply chains are no longer hidden beyond the reach of ESG agendas, making it important for companies to accelerate adoption of new manufacturing processes and environmental technology
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Formulating to fight a global pandemicPartnering with Spark Global and Stanford University, startup CDMO, Bravado Pharmaceuticals, uses a creative approach to survive during the Covid pandemic.
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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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DyadPalladate™ pre-catalysts: Cross-coupling made simpleThis technical brief will start by outlining the importance of cross-coupling catalysts in the industry. It will then weigh up the benefits of existing in situ and pre-formed catalysts. The remainder of the technical brief introduces Johnson Matthey’s DyadPalladateTM pre-catalysts as a cost-effective and greener alternative to traditional in situ systems.
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Formulation of Sustained-Release Ketorolac Tromethamine PelletsThe authors evaluated the effect of polymer composition on the drug-release profile and the effect of storage conditions on dissolution characteristics.
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Enabling the Virtual Human Through Physiologically-based Pharmacokinetic ModelingBasic principles of physiologically-based pharmacokinetic (PBPK) modeling and its impact in streamlining the drug development process are reviewed.
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When Is It Appropriate to Outsource Bioanalysis Work to a CRO?When considering whether to outsource work to a CRO, there are a number of factors to assess, including the type of work that may be outsourced, regulatory considerations, and needs for the study.
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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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Optimizing Quality by Design in Bulk Powders and Solid DosageCase studies on the manufacture of a bluk powder and the development of a tablet show the application of QbD principles.
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Navigating International PharmacovigilanceInternational pharmacovigilance for biotechs brings about a particular set of challenges, especially for small companies, which face the same rigour as large pharma companies.
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Development of Orally Disintegrating Tablets Based on a New ExcipientThe authors examine the effectiveness of an excipient comprised of mannitol, polyvinyl acetate, and crospovidone using model actives loperamide hydrogen chloride and caffeine.
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Leverage the Power of Recipe-Driven Execution and StandardizationStandardized manufacturing through a Recipe-Driven Execution environment and digital twins minimizes effort duplication while simplifying operations, harmonizing production processes, and accelerating speed to patient.
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Large-Scale LNP Process Conversions: The many hurdles of LNP scale-up and what to considerLipid nanoparticle (LNP) formulation development begins on a small scale, often with homemade or benchtop setups, using syringe pumps and easily accessible micro-mixing systems. Once a promising formulation has been identified, the next step is to transition to standardized large-scale impingement mixing systems, such as the high flow T-mixing pumps that were used to produce the COVID-19 vaccines (Sealy 2021). Formulators need to consider a number of factors when scaling up novel LNP systems. These include flow rates that affect LNP particles, solvent removal, risk factors when changing equipment, and the impact of tangential flow filtration sensitivity. In this technical note, we discuss these factors and what needs to be considered when developing a cost- and time efficient large-scale process.
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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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How a Lack of Critical Thinking is Hindering Regulatory ComplianceWhy critical thinking must be applied before technology to ensure regulatory compliance.
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Determining Efficacy and Proper Methodology in Cleanroom CleaningIt is vital to consider optimal cleaning and disinfection practices when operating a cleanroom.
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Report From: IndiaWhile the world pulls itself out from one of the worst crises in decades, Indian pharmaceutical companies are trying to capitalize on falling company prices by increasing their takeovers.
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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.
