Search results for " CMC"
Article
Breakthrough Drugs Raise Development and Production Challenges
Achieving fast approval of a breakthrough therapy creates challenges for manufacturers looking to develop CMC data in roughly half the time, noted Brian Kelley, vice-president for bioprocess developme…
Article
Regulatory Requirements for Safe and Efficient Biologic Drug Development
Another good practice to think about is as you get in that commercialization and get the application ready, you're putting all the different pieces together—the clinical side, the CMC side, on and on.…
Article
Platform Technologies Improve Protein Expression
“Consequently, platform expression technologies may lead to substantial benefits in terms of speed to market, assuming CMC aspects are on the critical path, and reduced cost of goods manufactured (COG…
Article
Manufacturing Standards Key to Advancing Cellular and Gene Therapies
Manufacturing Standards Key to Advancing Cellular and Gene Therapies
FDA works with industry on strategies for assuring high-quality regenerative medicines.
By Jill Wechsler
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Article
Regulatory Challenges in the QbD Paradigm
Both offices share regulatory oversight and cGMP implementation of CMC standards as described in the biologics license application (BLA) and supplements. Both offices assess standards, inspect manufac…
Article
Moving Biosimilars Forward in a Hesitant Market
“As mentioned earlier, [companies] have to provide much more CMC [chemistry, manufacturing, and controls] data for biosimilars compared to the innovator, and that takes time. [Companies] have to estab…
Article
Driving Improved Access to Biosimilars
Thomas Linneman, head of regulation CMC customer solutions at Solvias, divides them into monoclonal antibodies, hormones, and Fc fusion proteins and cytokines (4). Although approved, these drugs are n…
Article
An Analytical Approach to Biosimilar Drug Development
The outlined step-wise approach involves a detailed evaluation of the proposed biosimilar product against the approved reference product, first with respect to extensive CMC [chemi st ry, manufacturin…
Article
FDA Seeks to Enhance Manufacturing of Cell and Gene Therapies
This update of a 2008 advisory describes how manufacturers should provide sufficient CMC information to assure the safety, identity, quality, purity, and strength/potency of investigational gene thera…
Article
Speed and Flexibility Are Dual Goals for Biopharma Operations
…r 2015), the agency outlined a process for biopharmaceutical companies to open a dialog prior to the CMC filing with the Emerging Technology Team (ETT) at the Center for Drug Evaluation and Research …