INSIGHTS ON FACILITY DESIGN

• Audience Q&A

  Every Cell & Gene Live dedicates time to answering real-time questions from the audience. During “Building An In-House Cell & Gene Manufacturing Facility – Best Practices & Lessons Learned,” panelists Will Junker, Head of Vector Manufacturing Quality at Kite Pharma and Mitch Lower, SVP of Technical Operations at Kriya Therapeutics provided thoughtful and detailed responses to audience questions on everything from utilizing pre-fab units, exit strategies, risk mitigation, and much more.

• The Role of Automation in Manufacturing

  In transitioning from lab bench processes to manufacturing, underestimating scalability is common. Automation, for example, can eliminate the variable human factor of manual processes. Automated instruments promote process and product standardization because they are programmed to operate with consistency. During this segment of Cell & Gene Live “Building An In-House Cell & Gene Manufacturing Facility – Best Practices & Lessons Learned,” panelists Will Junker, Head of Vector Manufacturing Quality at Kite Pharma and Mitch Lower, SVP of Technical Operations at Kriya Therapeutics, the panelists cover how automation and robotics can address the complexity of manufacturing life-saving therapeutics.

• Speed to Clinic

  Does or should speed to clinic impact a company’s decision to build versus buy? When it comes to capacity and anticipated demand, what were some of the things Kite accomplished with its facility that are now considered best practices? What about lessons learned regarding capacity and meeting anticipated demand? Panelists Will Junker, Head of Vector Manufacturing Quality at Kite Pharma and Mitch Lower, SVP of Technical Operations at Kriya Therapeutics Junker tackle these questions and more during this segment of Cell & Gene Live “Building An In-House Cell & Gene Manufacturing Facility – Best Practices & Lessons Learned.”

• Building the Team

  When building a production line from lab-based processes, sometimes staff primarily familiar with research might not know the specifics of regulations relating to late-stage drug production. During this segment of Cell & Gene Live “Building An In-House Cell & Gene Manufacturing Facility – Best Practices & Lessons Learned”, panelists Will Junker, Head of Vector Manufacturing Quality at Kite Pharma and Mitch Lower, SVP of Technical Operations at Kriya Therapeutics talk us through how to build a team that has the skillset needed to run a GMP facility.

• Timelines and Milestones

  6/7/2023

  During this segment of Cell & Gene Live “Building An In-House Cell & Gene Manufacturing Facility – Best Practices & Lessons Learned”, panelists Will Junker, Head of Vector Manufacturing Quality at Kite Pharma and Mitch Lower, SVP of Technical Operations at Kriya Therapeutics talk to the audience about some of the major milestones and timelines that must be met throughout the building process.

• Cost Versus Labor Model

  6/7/2023

  During this segment of Cell & Gene Live “Building An In-House Cell & Gene Manufacturing Facility – Best Practices & Lessons Learned”, panelists Will Junker, Head of Vector Manufacturing Quality at Kite Pharma and Mitch Lower, SVP of Technical Operations at Kriya Therapeutics explain how companies can balance the cost and labor model, as an empty GMP facility costs a great deal of money.

• The Why Behind Build in “Build Versus Buy”

  6/7/2023

   

  Cell & Gene Live’s audience is comprised of companies of different sizes, business models, and needs. Manufacturing looks different to each company, but in-house manufacturing offers the appeal of having complete control over your product and can provide long-term cost benefits. Are you and your team ready to take on the demands of Good Manufacturing Practices (GMP), compliance, and regulatory approval?

• How To Best Optimize mRNA Production Workflows

  4/11/2023

  Multiple steps in the mRNA manufacturing process can appear more complex than they have to be. Learn how to simplify your approach and produce the best possible mRNA vaccines and therapeutics.

• Embracing GMP Manufacturing To Meet Pharma’s Future

  3/24/2023

  As pharma companies aim to overcome development obstacles, it is important to incorporate GMP expertise alongside novel technologies that can enhance the properties of APIs and dosage forms.