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IPQ Monthly Update, March 2015

During March, IPQ focused on the dialogue that has been intensifying at public forums on the daunting manufacturing and control challenges regulators and industry face in guiding the expanding array of cell and gene therapy (CGT) products now under development to commercialization. The five stories in the Monthly Update for March explore the CMC issues the new therapies pose from the European, US and Asian perspectives and where the emerging approaches are converging and diverging. Two of the stories delve further into the especially challenging but critical task of developing potency assays for the advanced therapies, and another spotlights Novartis’ advancing efforts to adapt biotech manufacturing and control technology and systems to make CGT commercialization a reality....

FDA Urges Improving Characterization, Manufacturing Control, and Potency Assay Design for Cell and Gene Therapies

FDA is advising companies developing cell and gene therapy (CGT) products to focus on improving the characterization of products, control of the manufacturing process, and design of the related potency assays....

Novartis Exploring Boundaries of Biotech Manufacturing and Control to Make Cell and Gene Therapy Commercialization a Reality

Novartis is among the major global pharmaceutical companies that are taking a hard look at how the advancements in biotech manufacturing and control technology and systems can be adapted to help make cell and gene therapy (CGT) commercialization a reality....

Potency Assay Challenges and Pathways for Cell and Gene Therapies Explored by Industry/Regulator Expert Panel

Putting in place a QC-friendly potency assay to support commercialization of cell and gene therapy (CGT) products will require an iterative process that needs to be thought out early in development with regulator input, experts involved are advising....

Regulatory Approach to Manufacturing and Control of Cell/Gene Therapies Draws International Discussion

Regulators around the world have been taking the opportunity at recent international forums to benchmark on their respective efforts to create a viable framework for regulating the manufacturing and control of cell/gene/tissue therapies and to consider harmonization possibilities....

Advanced Therapy Classification System on Regulatory Front Burner in Europe as Product Wave Builds Globally

As the wave of highly diverse cell/tissue/gene therapies under development continues to build globally, establishing a viable and mutually agreed upon classification system has become a top regulatory priority....

Revised EMA Guidance on Advanced Therapy Classification Out for Comment

In late June, EMA released a revised version of its “Reflection paper on classification of advanced therapy medicinal products.” The revision provides further clarification on when medicines may be classified as ATMPs and when they cannot. Clarification is added on: ● what constitutes a substantial manipulation of cells or tissues ● what is considered a non-homologous use […]

EC Reports on Advanced Therapy Regulatory Uncertainties

In late March, the EC published a report about currently unaddressed issues for “advanced therapy medicinal products (ATMP),” such as gene therapy or tissue engineering. Of concern in the report is that only four ATMPs have been approved in Europe, despite numerous applications, and that different member states have come to different conclusions regarding the […]

International Panel of Regulators Spotlights Current Biotech CMC Regulatory Problems and Convergence Pathways

The limitations, constraints and disconnects in the current CMC regulatory processes around the world are emerging into high relief as the biopharmaceutical community wrestles with how to get new medicines that fill critical healthcare gaps more rapidly to patients and how to facilitate manufacturing adjustments that better assure the quality of marketed products....

Compressed Breakthrough Therapy Timelines Require Intensified Upfront Sponsor Dialogue on CMC Plans Internally, With Contractors and With FDA

FDA is stressing that the ability to meet the aggressive expedited review goals of the breakthrough therapy pathway will hinge on the sponsor intensifying its upfront CMC coordination and communication internally, with outside contractors involved with drug substance and product manufacturing, testing and packaging, and with the agency....
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