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Biopharmaceutical Outsourcing Trends: The Next Decade
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Eric S. Langer
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New outsourcing industry sectors have become multibillion-dollar industries.
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Considerations in Biopharmaceutical Outsourcing
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Erik Greb
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Amy Ritter, PhD
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Because of the complexity of the manufacturing processes for biologics, transfer of these processes to a contract manufacturer presents challenges.
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Meeting Challenges in Contract R&D
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Angie Drakulich
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Representatives from leading CROs weigh in on key challenges tied to the biopharmaceutical R&D, including issues regarding bioequivalence, platform technologies, process analytics, and more.
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Biotherapeutics Outpace Conventional Therapies
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| By
Victor Coker
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Growth in infrastructure and process-development capabilities will be required to support the biologics market.
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Empire State Drug Development
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Peter Soelkner
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An architectural wonder teaches the biopharmaceutical industry a valuable lesson in project management.
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Key Considerations for Development and Production of Vaccine Products
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Anurag S. Rathore
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Suresh Jadhav
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Mahesh Bhalghat
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Shiraz Kandawalla
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Suma Ray, PhD
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Ashok Kumar Patra
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Challenges of vaccine development include regulatory, technical, and manufacturing hurdles in translating a vaccine candidate into a commercial product.
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Smart Outsourcing: Strategic Alignment, Risk Management, and New Relationships
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William Schmidt
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Ian Uydess
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Outsourcing in the pharmaceutical industry, until recently, has been largely confined to commercial manufacturing, packaging, and support for clinical trials.
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Managing the Quality Relationship for a Contractual Agreement: A CMO Perspective
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Susan J. Schniepp
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The author describes an equation that can be used to define the Quality relationship between a contract manufacturing organization and a client, including how to factor in both party's needs and regulatory commitments.
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