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Biologics Facilities: From now and into the future
Carl J. Carlson,
SME - Biopharma Process, Exyte

A Journey to Digitalization: Autolus Therapeutics 

Steve Chapman, Partner, Barry-Wehmiller Design Group

Strategies in Updating an Aging Pilot Plant Facility

Jennifer Jacob, Director, MERCK; Shane Helm, Mechanical Design Engineer, Precis Engineering, Inc.; Raymond Ducoat, Director, Process Operations, Merck & Co Inc

New Blender, Old Facility: A Case Study

Lonna Gordon, Senior Process Design Engineer, PM Group

Innovative Modular Facility Design

Peter Hanson, SME, Process Architecture, Exyte

Optimising Commercial Scale Autologous Cell Therapy Facility Design using Discrete Event Simulation

Philip Lyman, Director of Process Simulation, DPS

Plug & Produce: A case study of MODULAR PRODUCTION thanks to MTP (Module Type Package)

Giuseppe Menin, Industry Manager Pharmaceutical, Ing. Punzenberger COPA DATA GmbH

Is high voltage leak detection ready for Annex I and USP?

Andrea Sardella, PhD, Pharma Inspection Product Development, Stevanato Group S.P.A.

Modeling Defects during Tableting: Formation of Bubbles Resulting from Entrapped Air

Joseph Wright, Research Fellow/PhD Candidate, Drexel University

04:30pm - 06:00pm Eastern - November 1, 2022
Mr. Erich H. Bozenhardt, Session Leader, Lead Process Engineer, Regenerative Medicine, United Therapeutics; James Gannon, VP Quality, Trust, & Safety, PharmaLedger Association; Brian Richards, Session Leader, Cell & Gene Industrialization, Bayer Healthcare; Luciana Mansolelli, Director, Operations & Strategic Planning, Novartis

This panel discussion session will guide the audience through an exploration of distributed ledger (blockchain) technology and data interactions that are needed in the ATMP supply chain. Real life experiences related to ATMP data management with be discussed to support the topic. The panel will convey perspectives on the limits of applications of this technology and debate the use cases to provide a balanced view to attendees. 

This will inform attendees of possible considerations for implementation of distributed ledger technology. Following a brief introduction of distributed ledger technology, participants will hear from industry leaders about current use cases, the challenges, limits, and solutions to utilizing this technology for ATMPs.

04:30pm - 06:00pm Eastern - November 1, 2022
Ryan Mazur, Session Leader, Process Engineer, Genesis; Brant Bulgarelli, SME – Drug Product Fill/Finish, Exyte; Mr. Austin G. Lock, Technical Director, Group Head of Technology, PM Group; Mr. Sumit Verma, Senior Vice President, Commercial Manufacturing, Iovance Biotherapeutics, Inc.; Fabian Lugo Perez, SME - Engineering Operations & Capital Projects, Takeda Pharmaceuticals Inc.

With the increasing demand of personalized medicine, new technology is emerging that is at the forefront of front-end facility design that eliminates errors, cross-contamination, failure, and shutdowns; minimizes the timeline to market; and maximizes the output of any facility. The use of digital twins during design and the implementation of a robust operational advocacy campaign that combines the learnings from previous start-ups and operations with augmented reality (AR) design walk-throughs can lead to more effective first-time facility start-up’s and minimize the operational changes needed to bring facilities online faster. 

The use of this technology becomes imperative when the output of the facility is personalized medicine and there is only one chance of success within a confined timeline so there can be no errors or shutdowns with the facility design and its operation. Additional technologies used by such facilities identify those legacy technologies could lead to downtime so companies in the pharmaceutical industry are using collaboration to introduce new technologies that are more responsive, modular, and cost-effective than their legacy counterparts.

04:30pm - 06:00pm Eastern - November 1, 2022
Brant Bulgarelli, SME – Drug Product Fill/Finish, Exyte

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.

04:30pm - 06:00pm Eastern - November 1, 2022
Mr. Austin G. Lock, Technical Director, Group Head of Technology, PM Group

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

07:30pm - 10:30pm Eastern - November 1, 2022

Ticket Required

08:00am - 09:00am Eastern - November 2, 2022

10:45am - 11:00am Eastern - November 2, 2022