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Optimizing Process Development Early – A critical factor in successful viral vector scale up and large scale manufacture

Optimizing Process Development Early – A critical factor in successful viral vector scale up and large scale manufacture

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 In this podcast, I spoke with John Ketz and Denis Kole about viral vector production, including current manufacturing challenges, navigating the road to commercialization, and successful scale up strategies. We began the interview by discussing the strides made in cell and gene therapy. Denis shared information about the several approved therapies and the more than 2,000 ongoing clinical trials. Denis added that while the immense potential of these personalized therapies is becoming more and more clear, the challenges and bottlenecks surrounding their development and manufacturing are also becoming a reality. This is especially true when it comes to producing and delivering sufficient amounts of these complex therapies in a reasonable timeline. He explained that patient demands are increasing and the increase in IND applications for cell and gene therapies is resulting in increased demand as well as competition for resources. Access to qualified labor has become a significant bottleneck and likely will continue to remain so, at least for the foreseeable near future. He went on to say that the lack of standardized approaches for gene therapy modalities is another challenge that can increase the risk of failure. It can result in increased process complexity due to the need to screen large numbers of variables and can result in extended development times, which in turn affect the time to market for these needed therapeutics. In addition, the availability of manufacturing capacity is also becoming quite limited with the field currently reporting a significant backlog that can extend as much as 16 to 18 months. John added that he also sees capacity issues and it is something that Andelyn Biosciences® is trying to address. He also said that they are working on increasing speed and consistency. There are a lot of challenges that need to be addressed when moving from small flask or bench top scale into larger production scales. These may be challenges that you are not aware of or don’t encounter at small scale. It is important to be mindful of this during scale up. ADDRESSING CURRENT MANUFACTURING CHALLENGES To continue the discussion, I asked them to share the best way to address these challenges moving forward. Denis began by sharing that the demand for clinical and commercial manufacturing for advanced therapies is expected to continue to increase as more drug development companies entering the space and new therapies continuing their development journey. As a result, the manufacturing backlog currently observed will likely continue to remain present, if not expand. So, while large pharma and a few larger biotech companies may have the resources to internally support their clinical development and manufacturing needs, most of the smaller and medium sized drug development companies will continue to face challenges associated with quick access to qualified labor and access to extensive process expertise and available manufacturing capacity. He went on to say that this is where groups like Pall’s AcelleratorSM process development services and Andelyn Biosciences can play an important role with support through partnerships and collaborations. These types of collaborations really can provide the necessary resources and support for therapy developers to target shrinking the development timelines, reducing the risks associated with process development, and scaling to commercial scale. In addition, Pall and Danaher’s integrated single use bioprocess offerings, provide scalable solutions that can reduce some of the risks associated with the development and manufacturing of therapeutics. These solutions really aim to alleviate some of the bottlenecks and risks associated with the lack of a standardized approach. John added that at Andelyn Biosciences, they focus on creating a robust small scale model to ensure the consistency of the product when they move into larger scale. By doing this they can try to account for any of the differences that they might have, and can identify and define all of the critical process parameters throughout the whole process. Then they test the limits of all of these parameters in their model creation. He shared that working with a group like Pall, they have more consistency and confidence in the platform, so when they scale up, they know that it can work the first time and they don’t spend multiple rounds on large scale experimentation. John continued by saying that to address capacity issues, Andelyn is currently building a new manufacturing facility that will be able to handle additional large scale manufacturing for gene therapies that are coming online. CHOOSING A SCALE UP PLATFORM I then asked them if they could talk a little bit about the key factors that developers should consider in deciding which is the right technology for scale up. Denis replied that where the industry stands today, it is important to realize that there’s currently no one size fits all approach ...
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