Authors
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Biologics: Can There Be Abbreviated Applications, Generics, or Follow-On Products?In this question-and-answer discussion of "generic" biologics, the authors contend small changes in manufacturing of biologics dramatically affect the safety and efficacy of the therapeutic molecule.
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Bringing Innovation to Neglected Disease R&DA new report highlights the industry's contributions to neglected diseases and calls for further collaboration.
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The Challenges of Adopting Single-Use TechnologyInsights on single-use systems implementation and exploitation in biopharmaceutical manufacturing and processing, based on a QbD approach.
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Performing Hydrogen/Deuterium Exchange with Mass SpectrometryIn HDX studies, data are produced across multiple time points, multiple species, and with replicates.
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Tools for Enabling Process Analytical Technology Applications in BiotechnologyThe authors review the various analytical methods that can enable use of PAT.
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Development of an Alternative Monoclonal Antibody Polishing StepMAb polishing using salt tolerant interaction membrane chromatography.
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Correlating Product Lifecycle and Manufacturing Site Characteristics with Product DeviationsMIT survey results address product and site characteristics that statistically correlate with quality performance.
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A Robust CAPA System for a Global Supply ChainEnterprise quality management systems can help shift the quality emphasis from corrective to preventive actions.
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Preparing For the New ChinaChina's healthcare reforms generate uncertainty for its domestic pharmaceutical market.
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Integrating CMC Document Preparation into the Development Process for Vaccine INDsVaccine process development is complex, and so are the documents required before clinical trials begin. Technical writers and editors can effectively coordinate the timely authoring, reviewing, and auditing of regulatory documents, minimizing filing delays.
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Smart Outsourcing: Strategic Alignment, Risk Management, and New RelationshipsOutsourcing in the pharmaceutical industry, until recently, has been largely confined to commercial manufacturing, packaging, and support for clinical trials.
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How to Manage Effective Leadership when Change is the Only ConstantA disciplined approach to changing behavior can achieve change agility.
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Correlating Product Lifecycle and Manufacturing Site Characteristics with Product DeviationsMIT survey results address product and site characteristics that statistically correlate with quality performance.
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Modeling of Biopharmaceutical Processes. Part 2: Process Chromatography Unit OperationA review of some recent contributions in process chromatography.
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A New Way to Think About Outsourcing PartnershipsFuture sponsor-contract provider relationships will require more integration.
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Correlating Product Lifecycle and Manufacturing Site Characteristics with Product DeviationsMIT survey results address product and site characteristics that statistically correlate with quality performance.
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Vaccine Packaging at the Clinical Interface of Vaccine, Healthcare Worker, and PatientPackaging vaccines using prefilled syringes can increase dosing efficiency, reduce costs, and improve patient safety. This article is part of a special section on vaccines.
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Putting Risk-Based Decision-Making Where It BelongsFocusing on how risk affects the entire organization can improve the business bottom line.
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Bringing Innovation to Neglected Disease R&DA new report highlights the industry's contributions to neglected diseases and calls for further collaboration.
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Scale up of Fed-Batch Culture to Produce Plasmid DNA in Escherichia coli (Peer Reviewed)The authors present scale-up from a 5-L fermentor to a 50-L pilot-scale using the criterion of constant power consumption per unit liquid volume.
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Integration of a Single-Use Platform Process within an Innovative Facility DesignThe combination of single-use platform technology with modular facility construction is a template for flexible manufacturing.
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Bioprocess Manufacturing Tool Preview: A First Look at ISPE's Baseline Guide for BiopharmaceuticalsWith the biotechnology industry in the early phases of commercialization, many bioprocess companies are just beginning to build and operate commercial-scale production facilities.
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Overcoming Challenges in the Reconstitution of a High-Concentration Protein Drug ProductThe authors present approaches used to reduce reconstitution time of a lyophilized high-concentration protein drug product.
