In this presentation, the attendee will learn how to create a winning Operational Advocacy execution plan and how to avoid common pitfalls. By taking advantage of emerging technologies to facilitate front-end design (digital twin, VR/AR, etc.) one can avoid surprises from of overlooked design details. By employing the recommendations, one can provide the operational advocacy needed to produce the fastest output from one’s next facility. A proper advocacy strategy ensures critical continuity of operations-focused information from the beginning of the design effort through the completion of production ramp-up activities. Leveraging learnings from real-life manufacturing plant designs, start-ups, and operations is the most impactful means to create a right first-time facility. Traditional plant design process focuses on engineering and architectural requirements; the resultant facilities are typically quite capable, however, the day-to-day operability of a new plant is subject to high variability. The resultant rework (“operational enhancements”) necessary to meet operational ramp-up goals can be significant. By identifying operational advocates, and then defining an advocacy strategy that weaves these resources into the right project management and facility start-up structure, one can make an impactful execution strategy that maximizes the output to market from any new plant.

Major issues affecting the drug product industry include long lead times, high equipment costs, and a reliance on modified legacy technologies that introduce operational compromises. To meet the unprecedented demand for pharmaceuticals, the industry needs to adopt a more responsive, modular, technology approach that overcomes the major issues affecting the industry.

This presentation introduces a paradigm shift in Fill Finish technology (to be made public in Q2 2022). Using the backdrop of a collaboration case study between three international companies, each offering something very different, it describes the innovation journey from vision to solution. By starting with first principles and adopting a range of technologies such as robotics, smart manufacturing, modular design and construction, the presentation will describe how the companies combined their knowledge and skill sets, and modified existing product offerings, to design and build a flexible equipment offering that is unique within the industry. This pre-engineered, pre-qualified, and cost effective solution, offers the industry a scale-out, in-country solution that will enable wider filling opportunities.

Similar to Operation Warp Speed where industry demonstrated how collaboration resulted in delivering unimaginable results, this presentation reinforces the notion that collaboration between companies, can deliver enhanced outcomes for the benefit of the industry.

Category: Honorable Mention

Strategies for Building Next Generation Autologous Cell Therapy Facilities – A case study of Iovance Biotherapeutics Journey in building, qualifying and providing clinical patients with TIL therapy. Building an advanced commercial therapeutic manufacturing facility, let alone an autologous cell therapy product is extremely complex, highly customized and has many unique considerations that have to established prior to program execution. 

Iovance Biotherapeutics will share the challenges they faced when building a cutting-edge cell therapy manufacturing facility from site selection to build-out to operational readiness and execution. 

Key insights into the company’s approach to mitigating risk under accelerated timelines and through the Coronavirus pandemics will also be discussed.

• Building successful project workstreams and executing under tight timelines and complex deliverables
• Explain the site selection process including a “make vs. buy” business case analysis utilizing modular and single-use technology
• Share insights into building out infrastructure, quality and technical systems
• Learn about phased implementation, commissioning, and qualification strategies, change management, and regulatory approval processes