Cell and Gene Therapy: Taking a New Facility from Construction to Production

Cell and Gene Therapy production is one of fastest growing areas in biotechnology. There is increased demand to bring manufacturing spaces online quickly and with enough flexibility to accommodate process changes, especially for contract manufacturers. While this is becoming easier to accomplish through single-use technology and plug-and-play vendor packages, there are certainly pitfalls to navigate to ensure projects are delivered on-time and within budget.

This webinar will focus on the common pitfalls encountered during the startup phase of cell and gene therapy facilities, with special emphasis on lessons learned in the CMO space. Topics of discussion include:

• Design Flexibility: Key elements to incorporate into facility design to add manufacturing flexibility in the future, especially for CMOs
• C&Q strategy development: Following a risk-based approach is key to delivering a compliant package within tight time constraints. How can you tailor the C&Q to be flexible and fit the needs of multiple clients and/or processes?
• Scheduling Do’s and Don’ts: How to avoid project delays and how to accelerate certain phases

By paying special attention to these 3 items, projects can be delivered more quickly and in a compliant fashion, greatly reducing business risk and ultimately leading to a more profitable operation. Topics of discussion will stem from both direct project experience and industry guidance from organizations such as ISPE. The use of a risk-based approach will be highlighted, as this is one of the most key elements to reducing cost and adhering to schedule. While this oftentimes means early involvement from various groups, establishing risks to the product/process early in the project lifecycle reduce costly design changes and allow for a compliant, hyper-focused C&Q plan which can meet tight schedule constraints. More attention to this at the beginning of a project ultimately saves time at the end when adherence to schedule is much more critical.

Cell and Gene Therapy projects are especially challenging. The cutting-edge nature oftentimes makes for tight timelines, but also requires a lot of flexibility considering how rapidly technology is changing. This impacts all areas of the project lifecycle, and this webinar will discuss some of the areas where key improvements can be made to save time and money.

Speakers

Forrest Brown, Engineering Services Manager - Northeast Region, Sequence, Inc.

Forrest serves as the Engineering Services Manager – Northeast Region for Sequence. He has experience working on a variety of large greenfield and facility retrofit projects. Key skills include project management, HVAC/utility commissioning, and automation integration/validation. Most recently, Forrest and his team were tasked with delivering a gene therapy facility retrofit project to add several production suites, a fill finish suite, and MFG support suites. Though tight timelines were encountered, the team was able to deliver the facility on time using some of the strategies discussed in this webinar. Key decisions oftentimes hinged on the fact that this client is a CMO, which requires greater process flexibility and can complicate the qualification process. Ultimately, a balance is achieved between fully qualified solutions across all process ranges and client specific qualification that leads to additional work in the future.

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Jarred Christofaro, Engineering Services Manager - Southeast Region, Sequence, Inc.

Jarred Christofaro is a biomedical engineer who currently serves as a project execution lead on a large greenfield gene therapy project in the southeast. His current project involves the procurement, installation, and verification of over 100 single use unit operations to support production, filling, and packaging of a gene therapy product. His key expertise is in leading multi-disciplinary teams to design, commission, and verify equipment in a fast paced risk-based environment. Jarred’s focus on product quality and patient safety in a demanding project setting has proven to be a valuable attribute in his ability to lead a team to achieve critical milestones.

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