Search results for "regulatory agencies"
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Good Manufacturing Practices: Challenges with Compliance
Muzzin (Emergent): It is important to stay abreast of the latest guidance from FDA and other regulatory agencies. To ensure a robust understanding of your product and process, engage early, with speci…
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The Importance of Partnering for Bioanalytical Studies
Additionally, while still in draft form, ICH M10 Bioanalytical Method Validation guidance (3) has been a decade-long collaborative initiative of analytical sciences and regulatory agencies around the …
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Reimagining Affordable Biosimilars
EMA regulations do not require animal immunogenicity studies, while FDA and several other regulatory agencies require preclinical results prior to initiating clinical trials (28).
Table II.…
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FDA Framework Spurs Advanced Therapies
Greater clarity on the application of existing regulations will accelerate development of cell and gene therapies.
By Cynthia A. Challener
Ibreakstock/Shutterstock.co…
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Innovative Therapies Require Modern Manufacturing Systems
FDA and industry see progress and challenges in bringing cutting-edge medicines to patients.
By Jill Wechsler
FDA set a 19-year record in 2015 in approving more new drugs and biologics, and …
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mAbs to Watch in 2016
By Randi Hernandez
Of the 45 new molecular entities and new therapeutic biological products approved by FDA in 2015, nine products were monoclonal antibodies (mAbs). And there may be many more o…
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The Bullish Outlook for Biosimilars
Feb 01, 2015
By Jill E. Sackman, PhD, Michael J. Kuchenreuther, PhD
BioPharm International
There are several important reasons for stakeholders to be optimistic about prospects for b…
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Challenges and Trends in Biopharma Facility Design
Experts discuss the future of modular manufacturing and the challenges that biopharma manufacturers face in facility design.
Sep 1, 2014
By: Susan Haigney
BioPharm International
Volu…
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Addressing the Challenges in Downstream Processing Today and Tomorrow
IMPLEMENTING QUALITY BY DESIGN
The past decade has witnessed an increasing emphasis—by both industry and regulatory agencies—on implementing Quality by Design (QbD) principles. In 2008, the FDA's Of…
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Moving PAT from Concept to Reality
Still on the learning curve
The biopharmaceutical industry and regulatory agencies have recognized the value of PAT. Although many large multinational manufacturers have adopted and implemented va…