| FORMULATION |
Felicity Thomas
As biologics continue to push boundaries, the industry needs to take a holistic approach to formulation to ensure success.
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|MANUFACTURING: SOLID DOSAGE|
Michael Avraam
Containment valves and smart monitoring can keep employees safe and improve manufacturing efficiency when handling potent APIs, intermediates, and solid-dosage drugs.
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| MANUFACTURING: REFURBISHED EQUIPMENT |
Matt Bundenthal
Identify the warning signs and follow best practices for refurbishment to improve tablet press yields.
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| PEER-REVIEWED RESEARCH |
Matthias Wolfgang, Patrick Wahl, Stephan Sacher, Elen Gartshein, Johannes G. Khinast
This article summarizes results of a study that looked at optical coherence tomography as a way to monitor pharmaceutical spray coating processes in-line for tablets and pellets.
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| ANALYTICS |
Felicity Thomas
Harmonization of best practices and regulatory requirements will enable developers to find the best stability testing approach.
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| QUALITY |
Agnes Shanley
While allogeneic therapies can use existing regulatory and quality frameworks, autologous treatments will require pharma's adoption of true just-in-time and right-first-time concepts, says consultant James Blackwell.
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| FROM THE EDITOR |
Rita C. Peters
Do patients get what they pay for when they demand cheaper drugs?
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| US REGULATORY WATCH |
Jill Wechsler
FDA expects more than 200 investigational new drug applications for cell and gene therapies by 2020, causing the agency to strengthen its regulatory program.
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| OUTSOURCING OUTLOOK |
Ilene Roizman, Eric Langer
Single-use systems can be a cost savings for CMOs, and these savings can be passed on to clients and, ultimately, to patients.
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| ASK THE EXPERT |
Siegfried Schmitt
Simplification is crucial to maintain data integrity, according to Siegfried Schmitt, PhD, vice-president, technical at PAREXEL Consulting.
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