INSIGHTS ON FACILITY DESIGN
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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.
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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.
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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.”
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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.
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Timelines and Milestones6/7/2023
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.
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Cost Versus Labor Model6/7/2023
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.
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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?
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How To Best Optimize mRNA Production Workflows4/11/2023
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.
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Embracing GMP Manufacturing To Meet Pharma’s Future3/24/2023
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.
FACILITY DESIGN SOLUTIONS
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1,500 mL max rotor capacity 100,000 max RPM 802,400 x g
With all the features you expect, along with many advanced functions you won’t find anywhere else, the Optima™ XE simplifies use while offering secure loading for efficient, worry-free separations.
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Address biomanufacturing capacity with flexibility, speed and confidence.
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PUREplatform offers a platform, a premium strain, and cutting-edge screening, which together yield optimal protein expression that is uniquely tailored to each project.
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Explore Single-Use Fluid Transfer Assemblies that can streamline your development and manufacturing by providing a high-quality, rapid, and disposable sterile fluid transfer solution.
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Explore how we can collaborate and customize our service types to help reduce your workload, decrease instrument downtime, and maintain quality standards to meet regulatory requirements.