Emmanuel Adu-Gyamfi, Ph.D.’s Post

https://lnkd.in/emFZWqgS Please leave a comment on potency assurance for cell and gene therapy products. Unlike active drug ingredients cell and gene therapy products suffer to show the “dose” or “correct strength” due to packaging during downstream or upstream in biomanufacturing or there are not adequate markers to check the load/ effectivity.

As a perfect way to end 2023, the FDA released draft guidance on "Potency Assurance for Cellular and Gene Therapy Products." This comprehensive document underscores the pivotal role of potency assessment in ensuring the efficacy and safety of cell and gene therapy products. For those of us who work in the biomanufacturing industry, understanding FDA draft guidance documents is imperative to ensure regulatory compliance, uphold product quality, and navigate the evolving landscape of standards, fostering both innovation and patient safety. I think these are the key highlights: 1️⃣ Precision in Potency Evaluation: The guidance emphasizes the need for precise and standardized methods to assess potency, enhancing the reliability of therapeutic outcomes. 2️⃣ Risk Mitigation Strategies: It outlines strategies to identify and mitigate risks associated with potency variations, fostering robust product development and manufacturing processes. 3️⃣ Patient-Centric Focus: With a focus on patient outcomes, the guidance underscores the importance of consistent potency to optimize therapeutic benefits and minimize risks. In the current landscape of cell and gene therapies, this guidance couldn't come at a more critical time. As the industry witnesses unprecedented growth and innovation, the document provides a crucial roadmap to ensure the potency and effectiveness of emerging therapies. Do the reading! https://lnkd.in/euCydsvT #FDA #celltherapy #genetherapy #innovation #healthcareadvancements

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'CGT actors and process maps: Who does what in the supply of different cell and gene therapies', was published in April 2022. https://lnkd.in/eQYQj2yt This toolkit identifies and describes the organizational units, process blocks, and customer-critical paths for several CGT modalities and is an essential step in promoting understanding of the complexity of CGT delivery. It observes that, due to the customer-critical pathway on allogeneic and autologous cell therapy, there is a requirement for a control tower actor to coordinate delivery. Our new 'Cell and gene therapy outbound supply chain tool' picks up this journey by demonstrating the different value chains that CGTs have in the outbound supply chain, making it clear what different therapy classifications mean and their supply chain ramifications. https://lnkd.in/eKY6-dJj Both publications provide a common language, facilitate clear communication, and provide a better understanding of the challenges. Designed to help educate communities in this space whether just entering the CGT field or more established, they are tools by which industry can find common ways of working. #celltherapy #genetherapy #supplychain #biopharmaceuticals Information Technology BioPhorum

Nice to read, the newest draft of “potency assurance strategy for CGT products” 😊😊

The FDA have issued draft guidance on ‘Potency Assurance for Cellular and Gene Therapy Products’, along with a very informative webinar highlighting key aspects of the guidance. This guidance will replace the 2011 guidance for ‘Potency Tests for Cellular and Gene Therapy Products’ In this new guidance the FDA acknowledge the challenge that industry faces in developing suitable potency assays for CGT and thus recommend a multi-faceted potency assurance strategy following a science and risk-based approach. Key stages of this strategy include: ·      Develop a QTPP ·      Identify potency-related CQAs ·      Conduct a risk-assessment for each of these CQAs ·      Mitigate against identified risks through appropriate design and control of the manufacturing process and materials that impact these CQAs ·      Implement phase-appropriate appropriate release assays The guidance emphasises the possibility of a clinical hold at any stage of product development if an adequate potency assurance strategy is not implemented. FDA welcome feedback on this guidance, with comments due 27 March 2024. Given the importance of potency assurance for CGT products and the challenges we face developing suitable assays it is certainly worth spending time reviewing this comprehensive guidance and submitting any comments and suggestions. #cellandgenetherapy #fda #cber #potency

Cell Therapy Industry Looks for Ways to Sustain Growth Cell manufacturing trends should encourage optimism. The number of approved cell and gene therapies is bound to rise from today’s total, which is about 30 in the United States, because thousands of cell and gene therapy candidates are being evaluated in clinical pipelines. Besides contributing to the clinical success of cell and gene therapies, cell manufacturing represents an expanding market. According to Vantage Market Research, the global cell and gene therapy manufacturing market should maintain an annual growth rate of 18.2% through the rest of the decade, attaining a value of $15.4 billion by 2030. https://ow.ly/nJuL50QmbgQ

The landscape of gene therapy is burgeoning with possibilities, offering promising advancements to patients with genetic disorders. In a revealing conversation with European Pharmaceutical Review Magazine, Roger Palframan, head of U.S. research at UCB, sheds light on the current trends, key developments, and future disruptors in gene therapy. His insights offer a glimpse into the potential of gene therapies. You can read the full interview 👉https://lnkd.in/exhVR3kp

With the many successes we've seen in cell therapy over the past few years, it is little surprise that people are anticipating that the industry will see solid growth for the rest of the decade. To maintain this growth though, the industry must tackle a variety of challenges, more general issues like automation, talent acquisition, and supply chain management. This also extends to various industry-specific issues, such as managing product pipelines encompassing autologous and allogeneic cells, which have become increasingly complex and diverse. #CellTherapy #CellManufacturing #Bioprocessing

As many of you are aware, in late December the FDA announced the availability of a new draft guidance for advanced therapies, which provides recommendations for developing a science- and risk-based strategy to help assure the potency of human cellular therapy or gene therapy products. A potency assurance strategy is a multifaceted approach that reduces risks to the potency of a product through manufacturing process design, manufacturing process control, material control, in-process testing, and potency lot release assays. Understanding a product’s potency from the start is incredibly valuable… ensuring patients receive the full extent of a product's intended therapeutic effect. Laser Force Cytology analytics are a very important piece of an advanced manufacturing strategy due to the technology’s ability to deliver real-time insights, highly precise and reproducible data and all without the need for labels or florescents. Real-time PAT data insights hold the key to improved production and product consistency… it is great to see the increased focus on the need for precision analytics earlier in process development so that through a matrix approach, these data can allow for better understanding and rapid optimization throughout the manufacturing process. #CellTherapy #GeneTherapy #FDA #CGT