Agenda
Our education program offers cutting-edge technical sessions, shedding light on the latest advancements in the pharma industry.
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Facility Design & Delivery
Mon, 27 Jan
1045 – 1115
Facility Design & Delivery
JP Bornholdt, Autodesk
Kerry Ann Matthews, BioPhorum
Since the definition of the ballroom concept was first introduced in 2013 via ISPE's Baseline Guide: Volume 6 - Biopharmaceutical Manufacturing Facilities, the industry has looked for opportunities to further build in flexibility for bioprocessing and biomanufacturing into facility design, yet maintain a standard approach to facility layout options to allow faster delivery time without re-engineering of design approaches. This presentation will cover common industry challenges, considerations, and best practices in achieving a standard facility design approach, and how this can be applied to single-product, multi-product, or multi-modal manufacturing facilities, including a case study reference to the recent ISPE Facility of the Year Award winner Roche Genentech (South San Francisco Clinical Supply Centre) and their use of recent BioPhorum publications and initiatives to achieve this, as well as other industry standards and consortia works. The presentation will also include survey results (provided via BioPhorum) on the market need for, and perceived or anticipated operational and regulatory challenges surrounding, the implementation of a multi-modal manufacturing facility (e.g. closed systems usages, material transfer types, plant maturity, etc.) from a range of anonymized biomanufacturers.
1115 – 1145
Facility Design & Delivery
Jeremiah Genest, Just Evotec Biologics
This presentation will explore the application of ASTM E2500 (Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment) in the context of a continuous manufacturing facility for monoclonal antibodies. We will discuss the challenges and opportunities in adapting this standard to the unique requirements of continuous bioprocessing and how Just-Evotec Biologics has implemented this in constructing two mAb facilities. This presentation will provide valuable insights for biopharmaceutical professionals involved in facility design, quality assurance, and regulatory compliance. Attendees will gain a deeper understanding of how to leverage ASTM E2500 to enhance the efficiency and quality of continuous mAb manufacturing processes.
1145 – 1215
Facility Design & Delivery
Matt Hottelman, CRB Group
Chad Hafer, Kindeva Drug Delivery
See the future of pharmaceutical facilities for yourself in this virtual tour of Kindeva's Bridgeton, Missouri facility. Freshly completed in 2024, Kindeva's new world-class sterile fill-finish location includes more than 155,000 sq. ft. of dedicated aseptic operations space, two labs, two formulation suites, and approximately 11,000 square feet of fill suites. Conference attendees will get to explore the building while learning about the strategic decisions an integrated team had to make to have the facility designed, built, and running in just one year. The session will delve into the innovative use of phased packaging and modular construction techniques, which allowed for simultaneous design, offsite fabrication, and onsite assembly, significantly reducing the overall project timeline. This virtual tour and case study will offer valuable insights into the collaborative efforts and strategic planning that drove the success of the Kindeva project, setting a new benchmark for rapid, efficient, and innovative pharmaceutical facility construction.
1345 – 1415
Facility Design & Delivery
Daryl Kern, PM Group
William Gantz, Bristol Myers Squibb
The pharmaceutical sector is in a state of constant development, currently focusing on creating and building facilities that can support a flexible array of products (in terms of variety, quantities, and sizes). Additionally, there is a growing interest among some stakeholders to manage the entire process from clinical to commercial stages, including full lifecycle products, within a single location, as well as the co-location of various different product modalities. These trends indicate a requirement for facilities that are more adaptable, enabling manufacturing operations to be quickly relocated, retrofitted, or expanded with efficiency. This adaptability not only enhances operational efficiency but also allows companies to respond swiftly to market demands and regulatory changes, ultimately fostering innovation and reducing time-to-market for new therapies. Bristol Myers Squibb aimed to establish a global standard for a new agile manufacturing concept that would facilitate multi-modality manufacturing across different products, volumes, and scales, while also enhancing future capacity decisions and regulatory adaptability. BMS collaborated with PM Group to create a standardized design that would separate the Building Shell from the interior layout, allowing for rapid deployment at both existing sites and new locations globally. In line with the design approach, the team aimed to standardize technology platforms and shift away from "purpose-built" designs to develop generic Process Modality floorplates (modules). The team leveraged a significant portion of BMS’s current product pipeline as a benchmark to appropriately size process capabilities and technologies that would be included in Flex Modules. These modules were then designed to meet Launch capabilities while also being versatile enough to expand and accommodate Commercial Scale capacities in the future. A nimble strategy will allow BMS to build globally adaptable shell structures within their network, irrespective of product choices. This will enable swifter market entry, while also allowing ease of future repurposing. This presentation summarizes the design methodology employed to bring the innovative Agile Manufacturing Concept to fruition.
1415 – 1445
Facility Design & Delivery
Andrew Tyner, SMRT Architects & Engineers
Chris McAllister, SMRT Architects & Engineers
Kevin Rosenthal, RayzeBio A Bristol Myers Squibb Company
The radiopharmaceutical field is rapidly transforming the treatment of life-threatening; however, this rapidly growing medical sector presents unique challenges and safety requirements in management and manufacturing, compared to other treatments. Radiopharmaceutical production necessitates highly specialized equipment and controlled environments equipped to safely store, prepare, fill, and package radioactive materials. Designing facilities to accommodate these critical processes demands a meticulous approach to safety, efficiency, and regulatory compliance. In addition, it is crucial for the design team to be embedded early in the process, with the client, as requirements vary from client to client and product to product. This dynamic session will explore essential considerations for creating a strategic framework that ensures the successful implementation of a radiopharmaceutical program. The owner and design team will share lessons learned and successes from designing RayzeBio's 63,000-square-foot manufacturing building in Indianapolis, IN. Attendees will leave the presentation armed with strategies and best practices for future building projects on their own campuses.
1445 – 1515
Facility Design & Delivery
John Kenneally, Bayer
Alfred Penfold, PM Group
Adapting a mAbs Production Facility for Production of a Gene Therapy
A study has shown that it is possible to adapt an existing mAbs drug substance facility for gene therapy production. The proposal was to use the existing mAbs facility for both mAbs and a gene therapy on a campaign basis with minimal changes to the facility. The study refers to the modifications that were required to accommodate both modalities and how the facility would operate differently to accommodate the gene therapy. Introducing an ATMP retrospectively in an existing mAbs facility presents a number of risks that had to be mitigated due to the additional segregation requirements needed for ATMPs. A meeting was held with the FDA to review the planned proposals, and it did not result in any major concerns.
A study has shown that it is possible to adapt an existing mAbs drug substance facility for gene therapy production. The proposal was to use the existing mAbs facility for both mAbs and a gene therapy on a campaign basis with minimal changes to the facility. The study refers to the modifications that were required to accommodate both modalities and how the facility would operate differently to accommodate the gene therapy. Introducing an ATMP retrospectively in an existing mAbs facility presents a number of risks that had to be mitigated due to the additional segregation requirements needed for ATMPs. A meeting was held with the FDA to review the planned proposals, and it did not result in any major concerns.
Speaker Qualifications
Speakers selected to present at ISPE events are leading professionals in their fields. However, it may be necessary to make substitutions. Every possible effort will be made to substitute a speaker with comparable qualifications. Every precaution is taken to ensure accuracy. ISPE does not assume responsibility for information distributed or contained in these events, or for any opinion expressed.
Agenda Changes
Agenda is subject to change. Last minute changes due to functional, private, or organizational needs may be necessary. The event organizer accepts no liability for any additional costs caused by a change of the agenda.