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IPQ Monthly Update – September/October 2019 in Review

The issue begins with an exploration of how USP is evolving its standard setting approach for the new generation of biologic products and processes, and follows with a complementary review of the challenges in raw material and excipient use in biologics, in particular. The next two stories focus on the regulator and industry learnings, respectively, in gaining experience with the unique considerations that cell and gene therapies present in facility and operation management.

Industry Experience with Autologous Cell Therapies Underscores Need for Upfront Planning on Integrating Facility Design, Operations, and Supply Lines

Industry experience with autologous cell therapies is matching up with that of regulators in underscoring the importance of comprehensive integrated planning – encompassing internal operations and facility design as well as the complexities of the supply chain – to be able to meet future capacity needs.

The Processing and Formulation Complexities of Therapeutic Biologics Compel Heightened Focus on Excipient Needs

The processing and formulation complexities of the new generation of therapeutic biologics are compelling industry and regulators to take a hard look at the risks and requirements of the raw materials and excipients involved.

USP Views Early Broad Stakeholder Engagement as Essential in Developing Performance-Based Standards for Biologics

The U.S. Pharmacopeia (USP) views expanded early engagement with key stakeholders through workshops, roundtable meetings/studies, and Pharmacopeial Forum (PF) Stimuli articles as an essential component in advancing performance-based standards for biologic products.

CBER Advice on CGT Process and Facility Management Includes Early Consideration of Engineering and Capacity Needs

As its experience grows with reviewing cell and gene therapy (CGT) processes, equipment and facilities, CBER is strongly recommending that firms start early in thinking about the engineering and capacity needs of a commercial facility.

IPQ Monthly Update – August 2019 in Review

The three stories in the Monthly Update for August explore facets of the intense discussions that are now taking place at industry/regulator forums on the CMC challenges that need to be faced en route to realizing the promise of cell and gene therapies. In focus are: ● the dialogue at the NIIMBL annual meeting on these challenges and the industry/agency/academia collaboration needed to meet them, and ● an exploration by CBER and industry experts on the added CMC pressures created for CGTs by accelerated development and review timelines and how these pressures can be dealt with.

Preparing for CMC Changes is Difficult but Pivotal to Accelerating CGT Development, Industry Experts Are Stressing

Cell and gene therapy (CGT) sponsors are wrestling hard with how to prepare for having to make CMC changes throughout the development, submission, and post-approval stages, while facing accelerated timeframes and significant knowledge limitations.

CBER Reviewers Are Working with Sponsors in Exploring CMC Flexibility for Cell and Gene Therapies

Reviewers with FDA’s Center for Biologics Evaluation and Research (CBER) are working with sponsors to determine how and where flexibility can be applied in the type and extent of CMC information expected at the time of cell and gene therapy (CGT) product submissions.

CBER and CDER Directors Offer Insights on Overcoming Hurdles to Biomanufacturing Innovation at NIIMBL Annual Meeting

Among the ways that public/private collaborations could play a critical role in advancing cell and gene therapy (CGT) manufacturing would be helping create a non-proprietary set of adeno-associated virus (AAV) vectors, CBER Director Peter Marks proposed at the third annual meeting of the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL), held in Crystal City, […]

IPQ Monthly Update – July 2019 in Review

The first story in IPQ’s Monthly Update for July explores the FDA/CDER efforts to make its quality review process more standardized, transparent, streamlined, IT rich, and knowledge management friendly through its interrelated KASA and PQ/CMC initiatives. The second story explores the attention industry and regulators are now giving to the complex web of issues that come into play in the effective use of preservatives in pharmaceuticals.
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