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Restructuring Method Transfer Through Global SitesMethod-transfer kits help simplify analytical method transfer for global site certifications.
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A New Route to Pharma GDP Compliance and StandardizationA consensus-based approach to GDP lies at the heart of a new industry-wide program seeking to rationalize, standardize, and harmonize the adherence to pharma transportation norms and regulatory guidelines.
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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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Shining a Light on Photochemistry in FlowThe ever-increasing interest in photochemistry has inspired the development of innovative, modular flow photochemistry reactors.
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Exploring Best Practice Tech Transfer Methods for CGTsBest practice methods for the tech transfer of CGTs can increase process and analytics robustness while remaining scalable.
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Preparing for the Future: Expanding Capacity and Facilitating Multi-modalitiesCDMOs need to consistently demonstrate agility as demand increases for newly developed therapeutic modalities.
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Small is a Powerful Ingredient for Patient-Centric FormulationsPatient centricity is driving change in drug discovery and development, leading to a a new dawn in therapeutics.
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Survey of QPs on Remote CertificationDespite some improved understanding of adapted processes in light of the pandemic, information is still not filtered throughout the qualified persons community fully and more work by authorities and associations is required to improve communications.
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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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Digital Transformation: Accelerating Small-Molecule Drug DiscoveryAdvancing digital transformation can significantly reduce R&D costs and shorten drug discovery timelines.
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Perceptions and Considerations for Adopting Closed ProcessingThe combination of modular facilities and closed processing offers significant advantages in the production of biopharmaceuticals and is becoming a compelling option for manufacturing.
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Spectrophotometric Determination of LeadThe authors developed a reliable spectrophotometric method for determining and measuring trace amounts of lead in various samples.
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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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Behind CURIS System: A Gaseous Biodecontamination Solutions ProviderCURIS® provides portable and fixed decontamination systems. CURIS® has revolutionized the biodecontamination world with efficacious hybrid hydrogen peroxide decontamination, which delivers a mix of vapor and micro-aerosols to each space at precisely calibrated intervals. Recent challenges in staffing for Life Sciences inspired CURIS® to help labs save time and money by creating a single system that completes multiple decontamination tasks in virtually any space, including as an integrated system for on-demand biodecontamination.
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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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Biological Tissue Analysis by Infrared Laster Imaging (QCL) v2The analysis of tissue samples as a typical application of FTIR microscopy in biology to identify diseased or damaged tissue. It has typically been limited in use for research purposes due to the large amount of time needed to obtain the spectral data. The new HYPERION II significantly reduces the time to collect data and can be utilized for endless applications.
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Personalizing cancer therapyWe have recently launched a novel personalised therapy clinical trial to treat patients with late-stage colorectal cancer at George Mason University's Center for Applied Proteomics and Molecular Medicine (CAPMM). This is one of the most cutting-edge personalised therapy clinical trials in the world for several reasons including
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Product Annual/Quality Review: US–EU Comparative Analysis and InterpretationsThere are significant differences between the United States and European Union requirements for the annual review of records related to the manufacturing and control for pharmaceutical products and active pharmaceutical ingredients.
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Is Collaboration the Key to Accelerating Biotherapeutic Development?Vendors are finding ways to address the increasingly complex analytical challenges in the biopharmaceutical industry to further biotherapeutic development.
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Using Quality by Design to Develop Fixed-Dose Combination TabletsIn the present investigation, the fixed-dose combination (FDC) tablet of Atorvastatin calcium and Ezetimibe was prepared by a quality-by-design approach using two-level factorial design.
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Industry 1VQ Solutions: Replace Identity (ID) Testing of Incoming Liquid Drug Substance with ID by Visual VerificationA Post Approval Change (PAC) to replace identity (ID) testing of incoming liquid drug substance with ID by visual inspection is considered a low risk provided questioned listed in this example have been answered favorably. In that case the PAC can be downgraded from a prior approval to a notification to health authorities, and managed in the PQS with immediate implementation effect.
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Compliance vs. Competency: Designing CGMP Training with Performance Outcomes in MindAlternative approaches to training design can better address the desired performance outcomes in a GMP environment while delivering relevant information to meet regulatory compliance.
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Optimizing Drug Delivery Methods With NanotechnologiesShaukat Ali, PhD, Senior Director of Scientific Affairs and Technical Marketing, Ascendia Pharmaceuticals, highlights the benefits of the company’s nanotechnologies in supporting formulation development of poorly soluble molecules.
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Steps Towards Demystifying Risk-Based Decision MakingIt is important to understand the differences between risk-based decision making and other decision making in a pharmaceutical quality system.
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Printable Medicines: A Microdosing Device For Producing Personalized MedicinesThe authors describe a new method for the production of personalised medicines utilising ultra-precise microdrop printing technology.
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Printable Medicines: A Microdosing Device For Producing Personalized MedicinesThe authors describe a new method for the production of personalised medicines utilising ultra-precise microdrop printing technology.
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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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Active Packaging Reimagined: Novel Technologies to Derisk Drug Product StabilityStability and moisture challenges are likely to increase with the development of more potent APIs, larger molecules, and modified-release tablets. Learn about innovative packaging solutions to address the increasing need to protect hydrophilic oral solid doses from moisture and preserve drug stability. Live: Thursday, Sept. 17, 2020 at 11am EDT| 8am PDT | 4pm BST | 5pm CEST On demand available after airing until Sept. 17, 2021
