August 03, 2021
Cover Story
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Dosage form priorities are shifting to focus on user-friendliness, leading to greater engagement with outsourcing partners earlier in development timelines.
August 03, 2021
Peer Reviewed
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A robust selection of which product(s) and equipment to validate for cleaning is the cornerstone of a successful cleaning validation program. A strategy for selection of products and equipment for cleaning validation is presented.
August 03, 2021
Development
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Data sharing facilitates traceability, transparency, and accuracy while driving efficiencies and boosting quality of active pharmaceutical ingredients.
August 03, 2021
Development
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Amorphous solid dispersions can overcome the pH effect encountered with oral oncology medications.
August 03, 2021
Manufacturing
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An effective data structure and simple communication between production, logistics, and sales are essential for delivering this level of accountability, traceability, and security.
August 03, 2021
Manufacturing
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Controlling conditions and preventing contamination are crucial for cell growth.
August 02, 2021
Quality/Regulations
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Consider how to apply ALCOA+ to a building management system in non-clinical laboratories.
August 02, 2021
Outsourcing
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Collaborative partnerships can foster success in formulation development projects.
August 02, 2021
Operations
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Pharma and biotech supply chain companies are working together to help facilitate the transition of the pharma industry to net zero emissions compliance.
August 02, 2021
Regulatory Watch
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Full approval of COVID-19 vaccines may increase public confidence, but better coordination in development and review is needed.
August 02, 2021
From The Editor
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Excessive drug pricing is being scrutinized across Europe, as hefty fines are set to send out a clear message of intolerance to anti-competition conduct.
August 02, 2021
From the Editor
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Congress questions FDA on plans to catch up and move forward with facility inspections.
August 02, 2021
Ask the Expert
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Experts Susan J. Schniepp, distinguished fellow for Regulatory Compliance Associates, and Steven J. Lynn, executive vice-president, Pharmaceuticals for Regulatory Compliance Associates, provide answers to frequently asked regulatory questions about advanced therapy medicinal products.
August 02, 2021
Product Spotlight
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Eppendorf's CryoCubeF440 freezer has been redesigned to promote sustainability through various green features.
August 02, 2021
Product Spotlight
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ROSS Dual-Shaft Mixer is designed to place intense shearing and homogenization at the forefront.
August 02, 2021
Product Spotlight
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Syntegon's Syringe Inspection Line utilizes an AI vision system for the inspection of syringe flanges, stoppers, and cylinders.
August 02, 2021
Product Spotlight
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Bürkert's Fluid Control System offers customers scalable hydrogen peroxide disinfection.