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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....

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....

EMA Update on Adaptive Pathways Pilot Project

In an article published in Clinical Pharmacology and Therapeutics in December, EMA and its scientific committee members advocated using adaptive licensing pathways where appropriate in lieu of those used for traditional marketing authorizations. The article notes patients demand for timely access to medicines for unmet needs, a better understanding of pathologies for subgroups of patients, […]

Implementation Challenges for ICH’s New M7 Guideline on Mutagenic Impurities Will Present Themselves at Both the Development and Post-Approval Levels

Among the challenges that will present themselves to pharma companies in implementing ICH’s new M7 guideline on mutagenic impurities is the use of quantitative structure-activity relationship [QSAR] predictions in assessing the risks during development and for post-marketing changes....

FDA Equivalency Testing of Generic Cardio Drugs Starts with Metoprolol

In early May, FDA began an initiative to compare the bioequivalency of generic blood pressure medicines with innovator products. Starting with metoprolol succinate, the initiative will test nineteen other generic cardio products.

A Well-Thought-Out Immunogenicity Clinical Evaluation is Needed to Overcome Prediction Limitations for MAbs, NIBSC Expert Cautions

A well-thought-out clinical evaluation of the immunogenicity of monoclonal antibodies is a critical component of the regulatory clearance pathway and making predictions and generalizations short of this clinical analysis is dangerous, UK’s National Institute for Biological Standards and Control Biotherapeutics Group Head Robin Thorpe cautioned the attendees at a PDA MAb workshop in Basel, Switzerland in September....

EMA’s IMP Guideline Will Provide Shelf-Life Flexibility and EU Harmonization

Two key thrusts of EMA’s “Guideline on the Requirements for Quality Documentation Concerning Biological Investigational Medicinal Products in Clinical Trials” will be to provide flexibility in shelf-life determination for IMPs and to facilitate harmonization of the clinical trial application process across the EU....

Communication Between CMC and Clinical Groups is Key in IND Phase, FDA says

FDA Center for Drug Evaluation and Research (CDER) is stressing that communication problems between the CMC and clinical groups working in Phase I can result in important risks not being identified and can impede IND/Phase I progress....

Preparing for and Communicating Manufacturing Changes During Late Stage Development Smoothes Biotech Clearance Process with FDA

Comparability studies for changes which inevitably occur during Phases II and III for biotech products must be planned for by the firms conducting them, FDA is stressing. The agency is also cautioning that communication with FDA during the end-of-Phase-II and pre-Biologic License Application (BLA) meetings and through the submission and preapproval inspection important to understand common expectations and make it easier to work through issues that will arise due to these changes....

FDA Views Clinical Linkages as Key QbD Implementation Gap

As quality-by-design (QbD) implementation progresses, FDA is becoming aware of the scientific gaps that still need to be filled in. One area in particular that has generated considerable attention among industry and regulators is “understanding the link between what that product is and how it works in the patient – that is, integrating the field of biopharmaceutics into QbD,” ONDQA Acting Deputy Director Christine Moore stressed at a recent conference.

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