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Quality Management Systems for Small Biopharmaceutical OrganizationsWhat small biotechs need to know about quality management systems.
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Strategies for Optimizing the CMO-Client RelationshipPartner with a contract manufacturing organization that integrates best practices from project management, customer service, and Lean.
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Myriad Decision Places Biotech at a CrossroadsIn light of the new ruling, patent licensees may want to re-evaluate the strength of their licensed patents.
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Quality by Design: The Case for Change (Part II)A rigorous cost-benefit assessment can help to chart a cost-effective path forward.
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Development of a Novel Rolling-Tube Cell Culture Platform and Demonstration of System FeasibilityRolling-tube system balances scale-up accuracy and thoroughput.
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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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Outsourcing A Survival Strategy or a Tool for Speed to Market A Case StudyOutsourcing is becoming increasingly widespread and essential in the biopharmaceutical industry. Its imprint on biotech world business and on the development of biopharmaceutical drugs is becoming ever more pronounced. It is estimated that almost one-half of biopharmaceutical companies contract out at least part of the production of their products. On the other hand, those companies that do not outsource production often contract out some of their development activities.
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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).
