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Using Modified QbD to Develop a Novel Pediatric Formulation of EzogabineThe epilepsy treatment, Potiga, has been used off-label to treat specific types of epilepsy in some children. However, it has never been formally evaluated in pediatric clinical trials. Using a modified QbD approach, the authors have developed a granular formulation suitable for use in clinical trials involving infants and children.
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Building a Greener Supply Chain: Key Considerations for Cold ChainWith the majority of large pharmaceutical manufacturers aiming for carbon neutrality by 2030, reusable packaging remains a largely untapped approach in achieving measurable ESG gains.
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A Flexible Future: Adopting Reclosable, Flexible Pouches for Pharmaceutical PackagingFlexible packaging benefits align with challenges including an aging population, compliance requirements, e-commerce, serialization, and a need for recyclability.
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Strategies for Overcoming Common Challenges in Tech TransferThe complexities of tech transfer may be overcome by data-driven approaches, digital tools, and effective communication.
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Rentschler Biopharma: A 50-year Legacy of Exceptional CDMO ExpertiseExplore how Rentschler Biopharma duels biopharmaceutical innovation, spanning from pioneering biological products to cutting-edge cell and gene therapies
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Accelerate Clinical Trial Success with Genomics ExpertsWebinar Date/Time: Thu, Mar 2, 2023 1:00 PM EST
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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.
