| MANUFACTURING: LYOPHILIZATION |
Felicity Thomas
Technical advances in process understanding and control must be accompanied by a change in mindset.
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| PEER-REVIEWED RESEARCH |
John Wasylyk, Ming Huang, Bob Wethman, Kieran O’Connor
Spectroscopic-based control methods were introduced as equivalent alternative methods, first to a gas chromatographic method to monitor an in-process solvent exchange step and second to a potentiometric titration method to release a process input material for drug substance manufacturing.
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| TOPICAL DRUG MANUFACTURING |
Christopher Harrison, Sarah Pratt, Marc Brown, PhD
Using a QbD approach in the development and formulation of topical products will enable the drug developer to provide a robust control strategy for manufacturing.
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| COLD CHAIN |
Amber Lowry
Recent advancements in cold-chain technology offer improved transporting and storing of temperature-sensitive pharmaceutical products.
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| ANALYTICAL METHOD TRANSFER |
Agnes Shanley
When transferring a method from R&D to quality control, success hinges on discovering where "the best" and "the most reliable" intersect.
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| FACILITY DESIGN |
Eric Bohn, Magdalena Krapf
Storage and retrieval methods and the unique requirements found in building codes are crucial considerations.
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| REGULATORY UPDATE: ASEPTIC MANUFACTURING |
Agnes Shanley
Robotic isolators and single-use technologies are gaining ground, according to aseptic processing consultant Jim Agalloco.
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| BIOLOGICS |
Feliza Mirasol
The market for biosimilars in Europe remains consistently robust, with 16 new biosimilars approved in 2018.
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| SUPPLY CHAIN |
Felicity Thomas
A new initiative has been launched to help stimulate industry discussion on innovative tech for use across the drug supply chain.
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| EDITOR'S COMMENT |
Felicity Thomas
Political instability is causing uncertainty in Europe and wreaking havoc with US regulatory timeframes.
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| EUROPEAN REGULATORY WATCH |
Sean Milmo
Various groups and stakeholders from pharma, healthcare, and government are responding to a new draft environmental risk assessment guidance from EMA.
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| ASK THE EXPERT |
Susan J. Schniepp
Getting to the root of the cause can prevent future problems, says Susan Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates.
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