At the end of this month, two of my colleagues and I have the opportunity to speak at the IBC Life Sciences Cell Therapy Bioprocessing and Commercialization Conference in Alexandria, Virginia.
On September 30 during the conference, I will be giving a presentation entitled, “Partnering with a CMO along the Road to Commercial Cell Therapy Manufacturing.”
From me, you’ll be hearing about the three main hurdles to a commercial future for cell therapy:
1) The current state of manufacturing potentially leading to unsustainable products
2) Idle capacity in cleanrooms and manufacturing facilities driving cost of goods to unreasonable levels
3) Scalability from clinical- to commercial-level manufacturing
For each of these challenges, PCT offers strategic, practical recommendations to help cell therapy developers work towards successful commercialization. Topics I’ll cover include:
- Deliverability
- Comparability risk
- The need for strategic commercial manufacturing planning
- Challenges of a single-product manufacturing facility
- Commercial quality and cGMP infrastructure systems implementation
- The consortium model for commercial manufacturing
I look forward to discussing each of these points in more detail during the IBC conference, and I hope to see many of you at the event.
In addition to my presentation, two of my colleagues will also be speaking at IBC:
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On October 1, I will be moderating a panel on which my colleague, Ann Daus, PhD, Vice President, Quality Assurance and Quality Control, will be speaking on the topic of “Alignment with Commercialization: Addressing the Fundamental Challenges of Bringing Cell Therapies to Market”
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Also on October 1, my colleague Brian Hampson, Vice President, Global Manufacturing Sciences and Technology, will be delivering a presentation entitled, “What Can Automation Do for You and When – Strategic Considerations, Examples and Lessons Learned”
To request a download of the complementary PCT presentation, “Partnering with a CMO Along the Road to Commercial Cell Therapy Manufacturing,” click on the button below. Once you request the download, your presentation will be delivered to you after the IBC conference.
