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The News in Depth

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....

IPQ Monthly Update, January/February 2015

During January and February, IPQ explored several impactful initiatives that are underway in different areas of the pharmaceutical manufacturing and control arena to create standards and databases that will make both industry and regulators more effective and allow them to communicate better.  These include the efforts of: ● the industry-driven Allotrope Foundation to create lab data standards and the “lab of the future”● FDA in cooperation with industry to continue to implement the 2013 Drug Supply Chain Security Act ● regulators, industry and academia to upgrade pharmaceutical excipient databases, and ● Asian regulators, in line with those in the US and Europe, to address a new generation of regulatory challenges....

Asian Agencies Report on Progress in Addressing Emerging Regulatory Challenges at CASSS Biotech CMC Strategy Forum in Japan

Asian medicines agencies are joining those in the US and Europe in seeking to address the emerging regulatory challenges posed by: ● new classes of products such as cell-based regenerative medicines and engineered antibodies ● accelerated approval pathways ● biosimilars ● international convergence, and ● validation lifecycle management....

Allotrope Analytical Lab Data Standardization Effort Gaining Momentum with Better Analytical and Control Processes at Stake

The industry-based Allotrope Foundation is picking up momentum in its ambitious effort to create a framework for standardizing and sharing lab data, with more effective analytical and manufacturing control processes at stake....

Allotrope’s Vision of the Laboratory of the Future Aligns Closely with FDA’s Regulatory Objectives, Senior Industry Players Maintain

The effort of the Allotrope Foundation to create a common lab data format that is instrument and vendor “agnostic,” allowing for more efficient and compliant analytical and manufacturing control processes, aligns closely with FDA’s lab regulatory objectives, senior industry players involved are stressing....

Comment Review, Public Meetings, Supply Chain Pilot to Follow 2014 Bolus of FDA DQSA Track & Trace Guidances

In the wake of having issued a series of guidances in the latter part of 2014 to enable implementation of the 2013 Drug Supply Chain Security Act (DSCSA), FDA is now concentrating on: ● reviewing the comments and finalizing the guidances ● issuing required regulations ● scheduling public meetings ● performing a supply chain pilot program, and ● developing a licensing program for the various trading partners in the supply chain....
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