This is an opportunity to earn up to 3.0 PDH on the morning of the ISPE DVC Symposium & Exhibition. The program has two track (each with two sessions), and a panel discussion. Breakfast and lunch are provided. Located in the South Lounge Suites.

Please plan on joining us from 9:30 am - 10:00 am for breakfast and networking prior to the start of the sessions

TRACK 1 - Facilities Managment

Session A

10:00 am - 10:50 am 

Facility Programming for a Flexible Multi-product Cell Therapy Facility

Over the past decade the landscape of the pharmaceutical industry has changed with the innovations of new technologies, like ATMPs. It has never been more important for the industry to react to ever changing future capabilities. This presentation will discuss the importance of facility programming to develop a thorough conceptual design that sets the project on the right path of an efficient design that meet schedule and cost targets. The programming approach will walk through the development of a layout and challenges of defining criteria for a flexible facility. A case study of a Cell Therapy facility will follow to demonstrate the approach and key drivers for the facility design of a CDMO. The facility drivers focused on a flexible suite for multiple products, multiple clients and accommodation of all levels of therapy life cycle including clinical and commercial production considerations.

Speakers:

Christine Holbrook; Facilities & Engineering Lead, Center for Breakthrough Medicines

Christine Holbrook is the Facilities & Engineering Lead for the design and build out of Cell Therapy Manufacturing operations. This role includes input and review of facility detailed design, specification of process utilities, and equipment and facility CQV. Additionally, her role includes support of new Cell Therapy client tech transfers and configuration of the Cell Therapy suites to support new processes. Christine has previously worked as a consultant in Project Management and Process Engineering roles to start up operations, support CQV execution, and perform technology transfers in new Medical Device, Biologics, and Cell Therapy facilities. Most recently, Christine supported the MES design and build out as a process engineering SME for a commercial Cell Therapy product.

Kristina Pumphrey, PE; Director of Process Engineering, Precis Engineering

Kristina Pumphrey is the Director of Process Engineering at Precis Engineering, Inc. She is an accomplished process engineer with over 20 years of experience in the pharmaceutical and biopharmaceutical industries. Her broad knowledge base spans across several industry technologies. At Precis, she is responsible for translating user requirements into a working facility by specifying the equipment, controls, and interconnecting piping into an efficient layout that meets cGMP and regulatory requirements and results in a quality product. A certified Lean Six Sigma Black Belt, she uses her lean manufacturing expertise to help clients plan for the future by improving operational efficiency. She extends her pharma industry leadership to the professional community as a member of ISPE Biotech COP Steering committee and has spoken extensively about pharmaceutical facility design. She holds a Master of Science in Management and Technology from Widener University and a Bachelor of Science in Chemical Engineering from the Pennsylvania State University.

Session B

11:00 am - 11:50 am

Futureproof Your New Manufacturing Capacity Using Flexible Design and Modular Construction             and Operations

In this session you will learn how to create a “futureproof” manufacturing capacity based on using agile modular operations. The current approach for designing biopharmaceutical manufacturing facilities is to configure the layout around the process’s unit operations to provide smooth and efficient flow of in-process materials from one unit operation to another. The resulting layout optimizes the facility to a specific process’s requirements. However, the resulting facility is usually relatively inflexible for making significant changes in the process’s unit operations, execution sequence, or capacity scale. This inherent inflexibility makes the introduction of new products or the scale up or scale out of existing capacity difficult to achieve without making significant, costly, and time-consuming physical modifications to the facility.

As the biopharmaceutical manufacturing landscape becomes more complex with larger portfolios of products, decreasing product lifespans, high product failure rates, decreasing time to market requirements (e.g., pandemic therapies), the industry needs manufacturing capacity that can efficiently and rapidly accommodate a much broader range of process types, scales, and configurations. This session describes how a facility can be designed to support a wide variety of process configurations by being designed to rapidly adapt to different process configurations without requiring modifications to the facility’s layout.

Specifically, we will present how one can take general manufacturing process requirements and quickly turn them into a flexible, multi-purpose facility design utilizing 3D "digital twin" modeling software. The end result is a virtual walkthrough of the facility concept which will be demonstrated during the session. Further, we will present how one could utilize offsite construction activities to deliver the facility using a modular concept that should generate significant time savings from concept approval to the start of manufacturing activities. Lastly, we will demonstrate how the concept would allow for the rapid addition of "processing arms" to the facility during or post construction as a response to one of the many ever changing demand drivers introduced during the session.

Speakers:

Brant Bulgarelli; SME – Drug Product Fill/Finish at Exyte

Brant has more than 25 years of experience in the design, construction, and operation of Drug Product Fill/Finish facilities for clinical, contract, and commercial manufacturing. He holds a BS in Chemical Engineering from Drexel University in Philadelphia, Pennsylvania. Brant has completed a variety of projects including multiple award-winning greenfield/brownfield projects and has a significant end-user/operational leadership experience in the areas of clinical, commercial, and contract manufacturing (CMO). He is focused on advanced equipment and processing technology concepts and their implementation into drug product processes to make them more robust and safer for operations staff and the patient.

Mark Witcher; PhD; SME – Drug Product Fill/Finish at Exyte

Mark has 40 years of biopharmaceutical experience in executive, consulting, and engineering positions. Prior to joining Exyte, Mark was part of NNE’s Strategic Manufacturing Concept Group working on feasibility and conceptual design studies for advanced biopharmaceutical manufacturing facilities. Mark was an independent consultant for more than 25 years on operational issues related to: Process and product development; strategic business development; clinical and commercial manufacturing planning; tech transfer; and facility design and construction. He was previously the Sr. Vice President, Manufacturing Operations for a CMO Covance Biotechnology Services. Prior to Covance, he was Vice President of Manufacturing at Amgen, Inc.

TRACK 2 - Contamination Control

Session A

10:00 am - 10:50 am

Visible Particulate Contamination Control Strategies: Regulatory Expectations and Risk Management Techniques

The EU and US have recently provided updates to their regulatory expectations for visible particulate control and monitoring in parenteral products. This presentation will summarize those updates and industry trends for visible particle control and testing for traditional biopharmaceutical manufacturing and advanced therapy medicinal products (ATMP).

Speaker:

Stephen Langille; Principal Consultant, ValSource Inc.

TRACK 2 - Session B

11:00 am - 11:50 am

Contamination Control Strategy Development through Risk Assessment Tools & Assessment of Procedures

Owners are requesting engineering services to support development of a Contamination Control Strategy (CCS) Risk Assessment. The CCS will unify disparate contamination controls into a unified framework, as specified by current EudraLex Vol. 4, Annex 1 and in alignment with US FDA, PIC/S regulations as well as guidance documents issued by ISPE, PDA, and ICH.

CCS isn’t a new thought. Risk Assessments have always addressed the core aspects of preventing contamination and looking at facility design and potential impacts to product. What is new is evaluating the cohesiveness and the effectiveness of all the procedures and design documents as a whole – how they are each supported by and built upon by the other documents and how they work together to ensure the facility and operations are designed to operate in a way that prevents contamination of the product.

Speakers:

Jeff Odum, CPIP, Practice Lead for ATMPs and Biologics, Genesis

Jeff Odum is a globally recognized SME in Biomanufacturing Facilities that has over thirty years of experience in the design, construction, and commissioning of facilities in the biotechnology, and pharmaceutical industries. A recognized expert in biopharmaceutical manufacturing assets, Mr. Odum has authored over 60 published articles and four Industry reference books on subjects related to project management, GMP compliance, process improvement, and the design and construction of biopharmaceutical manufacturing facilities. He is a welcomed speaker at numerous international industry forums and conferences, presenting on topics relating to next generation facility design, bioprocess manufacturing, project management and GMP compliance. Mr. Odum, a Certified Pharmaceutical Industry Professional (CPIP), served as the North American Education Advisor to the International Society of Pharmaceutical Engineering (ISPE), is the serving Chair of the ISPE Global Biotechnology Community of Practice, and a contributing author to numerous industry baseline and reference guides focused on ATMP and biotechnology manufacturing, process development, project management and commissioning and qualification. He is a member of the ISPE technical training faculty and is a Teaching Fellow in North Carolina State University’s BTEC graduate program in biomanufacturing and a Guest Instructor for the North Carolina Community College System BioNetwork Program. He has led training efforts in fifteen countries in over 100 sessions, including training for global regulators from the US FDA, Health Canada, and the Chinese SFDA

David Raab, Senior Process Engineer, Genesis AEC

David Raab has facilitated GMP risk assessments for manufacturers in APIs, excipients, biopharma, cell and gene therapy, nutritional products, and personal care products. David is currently leading CCS development for Genesis AEC clients seeking to comply with the latest guidelines of Annex 1.

"Speed to Market" Panel Discussion - 12:10 pm - 1:00 pm

(Included in Ticket Purchase for Education Events)

Emerging Companies as well as established companies are challenged in the industry to accelerate the time from when the business decision is made for a new facility to support the strategic goals of the business to actual occupancy of the facility for the offices, R&D, clinical trials, manufacturing and CQV.

Emerging companies leaving incubator space are challenged to find sites, establish program and budget to build the spaces with the pressure of schedule and budget.

Schedule, Budget, and Quality are key components of every project. Can these three be achieved?

The key question we hear from emerging companies (as well as existing companies ) as they exit incubator spaces  and need facilities to accommodate their growth for offices, R & D, Clinical Trials, and Commercial Manufacturing is...  How fast can we be in the new space?

The format to address this issue is a lively interactive panel discussion involving the key players in the industry who will help the audience determine how to achieve this goal; the "real issues and road blocks" to an accelerated project plan will be discussed.

Moderator: 

Terry Jacobs , AIA; JacobsWyper Architects

Eric Bohn; JacobsWyper Architects

Tim Conrey; Scheer Partners, Inc.

Timothy Kelly; The Norwood Company

John Laino; Vaxart, Inc.

For more information on ISPE-DVC's 31st Annual ISPE DVC Symposium, Click Here

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