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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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Clinical And Cost Considerations Of Developing A BiosimilarBoth biosimilar and generic drugs have an abbreviated approval process; however, the clinical trial requirements differ enormously.
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A Four-Phased Approach for Evaluating a Quality Risk Management ActivityUsing the four-phased method to assess QRM can ensure continual improvement and that regulatory requirements are met.
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Method Development and Impurity Control in Late-Phase API ManufacturingOnce APIs move into later phases of development, an advanced impurity control strategy is vital and demands a comprehensive analytical methods approach.
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Running a Marathon in Flip-Flops – Part 2: The Value of Incorporating Prerequisites into Equipment QualificationEquipment qualification is a critical step in ensuring that a product or service is provided accurately and consistently with regards to manufacturing and testing. The time-saving attribute of adding prerequisites to a qualification program, along with the benefit of gaining the ability to track and trend problem areas, make the addition both worthwhile and cost-effective.
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Manufacturing OSD Forms: Key Trends Shaping the IndustryThe latest manufacturing technologies are essential for helping pharmaceutical formulators meet up-and-coming trends in OSD treatments.
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Reducing Packaging Costs for Prefilled SyringesBlow-fill-seal (BFS) technology presents an economical option for single-unit dose delivery of vaccines.
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QMM for Pharmaceutical Manufacturers– Implications for Drug Manufacturers, API Suppliers and Contract ManufacturersQMM principles and practices can positively influence a sustainable drug supply and bolster the bottom-line of drug manufacturers, API suppliers, and CMO/CDMOs.
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QMM for Pharmaceutical Manufacturers– Implications for Drug Manufacturers, API Suppliers and Contract ManufacturersQMM principles and practices can positively influence a sustainable drug supply and bolster the bottom-line of drug manufacturers, API suppliers, and CMO/CDMOs.
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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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Stability Studies: An Essential Step for Quality Management in Drug DevelopmentSufficient stability studies show a drug product meets regulatory requirements, therefore ensuring the drug reaches the patients who rely on it.
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An Alternative to the USP Disintegration Test for Orally Disintegrating TabletsThe authors propose an alternative to the USP disintegration test method. The method embraces physiological conditions of the oral cavity, as a screening tool for developing ODT products.
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REACH: has the cloud of confusion cleared?The pharmaceutical industry must understand its responsibilities to improve the safety of chemicals as defined by the REACH initiative.
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Tackling Cybersecurity Challenges in Legacy SystemsOngoing and emerging cyber-risks to legacy operational technology systems in bio/pharmaceutical manufacturing must be addressed.
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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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Automated Inspection of Pre-filled Syringes and Biologics During Fill/FinishShifts in pharmaceutical packaging have spurred tremendous growth in the pre-filled syringe fill/finish industry.
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Self-Emulsifying Drug Delivery SystemsThis review article explains how self-emulsifying drug delivery systems can increase the solubility and bioavailability of poorly soluble drug.
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Empowering Pharmaceutical Quality Control Laboratories through Strategic Change ManagementChange management is central to the evolution of quality control laboratories, but what factors can maximize patient outcomes?
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BioSpectra Announces Launch of New Class 6 Manufacturing SuiteBioSpectra Launches Class 6 Manufacturing Suite for Sterile filtered, GMP bulk Solutions, utilizing sterile, SUT packaging. First product launch: 5M NaCl solution made with WFI and multi-compendial salt.
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Looking Ahead to Factors Shaping Market ActivityDespite the market challenges caused by COVID-19, M&A activity in the life sciences sector is recovering well.
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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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Dose Administration, Compatibility, and Clinical Usability of BiologicsWebinar Date/Time: Mon, Nov 18, 2024 11:00 AM EST
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Navigating the Formality Spectrum in ICH Q9(R1)The degree of formality in a risk management process should be customized to the organization’s particular needs and the risks involved.
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Viral Vector API Characterization of Product-Related ImpuritiesFDA’s final CMC guidance sets expectations for manufacturing and quality for human gene therapy INDs. This article reviews existing analytical applications, focusing on viral vector characterization of impurities.
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Assessing environmental risk of pharmaceuticalsAn environmental risk assessment (ERA) is now required for all new pharmaceutical product marketing authorisation applications. The author outlines the steps to this procedure.
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How to Evaluate a CDMO’s Commitment to QualityWhat do you need to ask during the vetting and selection process to ensure your clinical or commercial program won’t be derailed by a quality-related problem?
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Leveraging Cygnus Technologies Quality with Fully Automated CHO HCP Assays on Ella: whitepaper:In this application note, we pair Simple Plex Assays on Ella with Cygnus 3G CHO antibodies for superior sensitivity and data reproducibility throughout bioproduction.
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Data Matrix Barcodes: Print Quality and Popularity On The UpThe 2D Data Matrix barcode is a familiar sight for most pharmaceutical manufacturers as printing is implemented to meet certain regulations.
