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PRODUCTION TRENDS
A data exchange program between GE Healthcare and Amgen aims to improve biologics manufacturing through analysis of how raw materials affect the process.
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MORE ON USING PROCESS DATA
Moving from paper-based to digitalized processes is the first step to enabling quality management and manufacturing to work in sync.
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While the multiple attributes method gains ground and traditional lab methods improve, broad efforts are underway to determine biopharmaceuticals' most significant critical quality attributes and enable real-time release.
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New technologies enhance quality, efficiency, and flexibility.
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IN THE NEWS
A solar panel installation at Novo Nordisk's North Carolina facility was initiated in March 2019 as part of the company's commitment to zero environmental impact globally.
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The latest expansion to the Pennsylvania facility represents the third phase of development of its biotechnology center of excellence.
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PACKAGING
INTERPHEX 2019 presented solutions for ophthalmic containers, materials, and equipment for forming primary containers, child-resistant and tamper-evident cartons, and cold-chain packaging.
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Exclusive Video
New Advancements in Capsule Filling Equipment
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EDITOR'S PICKS
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Lonza's fully automated plate-based PyroTec PRO Robotic Solution accelerates endotoxin testing of parenteral pharmaceuticals.
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The FactoryTalk Analytics LogixAI module from Rockwell Automation detects production anomalies.
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Equipment Showcase
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Leistritz manufactures twin screw extruders and systems for continuous mixing/devolatilization of API's with excipients. Lab scale and production scale equipment is available, and applications include melt extrusion and granulation. A variety of upstream and downstream equipment is available. Services include a process NJ development laboratory and ongoing training/workshops.
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UPCOMING WEBCASTS
Overcoming Challenges in Ophthalmic Drug Delivery Including Bioavailability and Sterility
Wednesday, June 19, 2019 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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Impact of New FDA Guidance on Bioanalytical Testing on Drug Development
Thursday, May 30, 2019 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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Requirements for Fully-Integrated Service Offerings in a HPAPI and Cytotoxic Environment
Two Live Events: Tuesday, May 28, 2019, at 10am JST | 9pm EDT | 6pm PDT
Tuesday, May 28, 2019, at 5pm JST | 10am CEST
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Designing Amorphous Dispersion Formulations for Poorly Soluble Drugs
Thursday, May 23, 2019 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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Technologies to De-Risk Biologic Candidates to Successfully Transition from Research to Clinic
Wednesday, May 22, 2019 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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EVENTS
June 3–6, 2019 | Philadelphia, PA
June 12–13, 2019 | Clinton, NJ
June 18–20, 2019 | Boston, MA
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eBOOK
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The editors explore new tools for bio/pharma lab studies—such as robotics, augmented reality, and advanced instrumentation—as well as best practices for method development, multiple attribute monitoring, lab mixers, and raw material testing.
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