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A Study of Leachables for Biopharmaceutical Formulations Stored in Rubber-Stoppered Glass VialsA systematic approach facilitates formulation component selection.
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Final Word: Riding on the Coattails of US PatientsIn general, people in other countries pay less for brand-name prescription drugs than people in the US. As a result, some Americans travel to Canada or Mexico to get their prescriptions, and an increasing number are using the Internet to buy drugs from other countries.
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Analytical Tools for Process and Product CharacterizationSelect the best approach to determine critical quality attributes.
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Mathematical Programming for the Design and Analysis of a Biologics Facility-Part 2An algorithmic approach to fine tune facility design and predict capacity.
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An Alternative Platform for Rapid Production of Effective Subunit VaccinesAdjuvant activity can be greatly improved by appropriate formulation of cytosine-phosphorothioate-guanine oligodeoxynucleotides (CpG ODNs).
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Tangential Flow Filtration for the Recovery of Acellular Pertussis Vaccine ComponentsMembrane-based TFF technology can ease scale-up and provide a higher recovery percentage compared to conventional purification methods.
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Technology Licensing — From First Steps to Executing a PlanCarefully prosecuted patent applications lead to patents with valid and enforceable claims that provide broad coverage for your technology.
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Using Simulation to Address Capacity LimitationsModeling tools help process engineers optimize a biopharmaceutical facility’s capacity.
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Scale-Up and Comparison Studies Evaluating Disposable Bioreactors and ProbesProcess performance was comparable across all scales, and fiber optic sensors appeared interchangeable with conventional probes.
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Supplier Quality Management: A Risk-Based ApproachA systematic classification system makes supplier quality management feasible, even if you are dealing with hundreds of suppliers worldwide.
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Build Versus Buy in the Current Biotech Market EnvironmentHow current economic conditions affect your build-or-buy decision.
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Quality by Design for Biotechnology Products—Part 3Regulatory flexibility can make continuous improvement possible.
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Ensuring Product Quality and Managing Risk: Validate, Verify, ImplementBiopharmaceutical companies must follow an active approach to managing their supply chains.
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Quality by Design for Biotechnology Products—Part 3Regulatory flexibility can make continuous improvement possible.
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Best Practices for Formulation and Manufacturing of Biotech Drug ProductsHow to maintain product stability and prevent particulates.
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Media Development for Mammalian Cell CultureOnce a necessary "magic ingredient" of media for mammalian cell culture, serum is rapidly being eliminated from media for biotherapeutic processes.
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Using NMR Spectroscopy to Obtain the Higher Order Structure of Biopharmaceutical ProductsSimple methods can characterize polysaccharide vaccines and recombinant cytokines at high resolution.
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Scale-Up and Comparison Studies Evaluating Disposable Bioreactors and ProbesProcess performance was comparable across all scales, and fiber optic sensors appeared interchangeable with conventional probes.
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Use of Contract Analytical Laboratories: A Pfizer Global Biologics PerspectiveBy following key strategies, companies can reduce the risk and increase the benefits of outsourcing analytical development and testing
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An Alternative Platform for Rapid Production of Effective Subunit VaccinesAdjuvant activity can be greatly improved by appropriate formulation of cytosine-phosphorothioate-guanine oligodeoxynucleotides (CpG ODNs).
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Analytical Tools for Process and Product CharacterizationSelect the best approach to determine critical quality attributes.
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New Approaches to Improved Vaccine Manufacturing in Embryonated EggsRecombinant vector technologies can improve the yield and lower the cost of egg-based influenza vaccine production.
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Rapid Assessment of Molecular Similarity between a Candidate Biosimilar and an Innovator Monoclonal Antibody Using Complementary LC–MS MethodsIntact protein LC–MS detected a mass variance of 62 Da and peptide mapping located a difference of two amino acids.
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Quality by Design for Biotechnology Products—Part 3Regulatory flexibility can make continuous improvement possible.
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Effective Auditing of CMOsIt is important that all stages of the audit be given an equal measure of attention.
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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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QbD: A Roadmap to AdoptionThe nimbleness of biotechs makes them well suited to implementing QbD. Here's how to get started.
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High-Cell-Density Culture to Produce Plasmid DNA for Gene Therapy in E. coliHow to produce Plasmid DNA in a high-cell-density culture.
