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Moisture-Activated Dry GranulationMoisture Activated Dry Granulation (MADG) was developed in response to the difficulties experienced with wet granulation, in terms of endpoint, drying and milling. Wet granulation process endpoint is very sensitive to granulation time and shear. The wet granules need to be dried to a narrow range of moisture contents, which is difficult. The dried granules need to be milled, but the milled granules often have either too many fines or too many coarse particles (or both) - an undesirable bimodal distribution.
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Application of the Risk Evaluation Matrix as per USP <665> and <1665> for Evaluation of Leachables Risk from Single-Use Components Used in BiomanufacturingDetermining E&L risk from single-use components can be used to build the level of extractable profiling and PERLs.
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Addressing Developmental Challenges of Gene Therapy Viral VectorsSignificant improvements have been developed to tackle the challenges in viral vector manufacturing at each stage.
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Seven Trends Shaping the Future of Pharmaceutical Formulation DevelopmentEmerging new technologies and disruptive manufacturing concepts are providing new opportunities for pharmaceutical companies.
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Multivariate data analysis easily retrieves insight from a wealth of dataStatistics are often viewed as confusing and complicated, but multivariate data analysis (MVA) methods can be used to amass knowledge simply.
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Dissolution’s Next Challenge–NanoparticlesNanoparticles are increasingly being used to overcome low solubility and poor permeability.
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Inside USP: USP Metals Testing: A Workshop ReportAttendees at a recent workshop endorsed new methods to detect metals in drugs, dietary supplements, and food ingredients.
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The Role of Dendrimers in Topical Drug DeliveryThis review provides an update of how dendrimer technology is being applied to the development of novel systems for various topical delivery applications.
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The Role of Dry (Water-free) Process Equipment Cleaning in Continuous Pharmaceutical ManufacturingThe growing use of continuous manufacturing in the pharmaceutical industry merits a review of the application of dry cleaning and sanitization methods, especially for non-sterile oral solid drug product manufacturing of dry powders.
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Due Diligence Assessment of CMC ActivitiesFor planned acquisitions or licensing, a careful analysis of CMCl factors is vital to ensure no problem areas are overlooked.
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Navigating a New Standard in Microbial Protein ExpressionKBI Biopharma has created a platform E.coli resulting in a PURE, efficient platform expression strain - PUREcoli™ - to reduce impurities and reach higher titers.
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Trends and challenges of biopharma manufacturingThe whole pharma/biopharma industry is under pressure to deliver cost-effective new drugs; however, the number of new drug applications is getting lower as the size of investment is increasing.
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How Pure is Pure? Understanding Reagent Purity GradesAs interest in cell and gene therapies continues to grow, the need for safe and consistent reagents to support research, development, and manufacture efforts also increases.
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Designing An Effective PAT-Driven Scale-Up Of Lyophilization ProcessesThis article examines the difficulties in designing lyophilisation processes that can be faithfully scaled up to production volumes and suggests the most effective ways in which this can be achieved.
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Manufacturing Considerations for Sourcing GMP Fermentation ServicesThe authors describe the critical aspects of an ideal fermentation services provider.
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Colorless and Soluble High-Performance PFAS-Free Polyimide Materials from Aliphatic AnhydridesSara Greco, R&D Chemist at Valsynthese, part of the SSE Group, covers the beneficial properties of polyimide materials and the key role that aliphatic anhydrides play in the enhancement of those properties.
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Growth in Cell and Gene Therapy MarketBiopharma focuses on streamlining biomanufacturing and supply chain issues to drive uptake of cell and gene therapies.
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Detecting Apparent Total Nitrosamine Content in Pharmaceutical DrugsScreening for apparent total nitrosamine content with a thermal energy analyzer offers a rapid way of identifying contaminated drug products.
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Perspectives and Challenges of Nanomedicine in Gene SilencingAdvances in nanomedicine have provided several potential candidates for safe and effective delivery of siRNA.
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How Integrated Project Delivery Enables Speed: A Phase-By-Phase GuideBy eliminating the waste involved in traditional approaches to project set-up and execution, integrated project delivery helps innovators in the European life sciences market meet their fast-track delivery targets.
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A Harmonized Approach to Performing a Risk-Based Audit Trail ReviewThe IQ Working Group has defined a pragmatic risk-based approach to audit trail review, where it is only required for high impact GxP data.
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Single-Cell Proteomics Enable Advancements in Disease ResearchInnovations in single-cell analytics have advanced the progression of cell biology research, which has brought new understanding of disease mechanisms.
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Collaborative Efforts Address Key Data Integrity ChallengesMaintaining a quality culture across the diverse functions in a bio/pharmaceutical company is difficult. Representatives of the Quality Coordinating Committee of IQ Consortium report on collaborative efforts to address data integrity and the modernization of FDA’s good laboratory practice regulations.
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Process Impurities Clearance in BiologicsThis white paper discusses developing optimal platform analytical methods with partner CDMOs for effective process impurities clearance in biological drug substances.
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Simplify Patient-Centered Clinical Trials With Trusted Data Foundation and Machine Learning PracticesA common obstacle life sciences organizations face during clinical trials is obtaining the right patients and promoting consistent engagement. High-quality data and technology can be used to streamline clinical trials and enable omnichannel experiences.
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Viewpoint: Precompetitive Collaboration Drives Pharma Industry InnovationThe IQ Consortium marks a decade of impactful innovation of collaboration through a network of pharmaceutical companies driving change for the bio/pharmaceutical industry.
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The Importance of Titrations in Pharmaceutical Analysis: From the Basics to the Modern Method***Live: Wednesday, February 24, 2021, 1pm EST | 10am PST | 6pm GMT | 7pm CET*** Titration plays an important role in pharmaceutical analysis. Despite the recent attention given to chromatographic methods, several applications are only feasible by titration, making it a fit-for-purpose method for many analytes. For example, distinguishing between carbonate and bicarbonate or monobasic and dibasic phosphate salts can only be accomplished by titration. *** On demand available after final airing until Feb. 24, 2022.***
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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.
