BEGIN:VCALENDAR PRODID:-//Microsoft Corporation//Outlook 16.0 MIMEDIR//EN VERSION:2.0 METHOD:PUBLISH X-MS-OLK-FORCEINSPECTOROPEN:TRUE BEGIN:VTIMEZONE TZID:W. Europe Standard Time BEGIN:STANDARD DTSTART:16011028T030000 RRULE:FREQ=YEARLY;BYDAY=-1SU;BYMONTH=10 TZOFFSETFROM:+0200 TZOFFSETTO:+0100 END:STANDARD BEGIN:DAYLIGHT DTSTART:16010325T020000 RRULE:FREQ=YEARLY;BYDAY=-1SU;BYMONTH=3 TZOFFSETFROM:+0100 TZOFFSETTO:+0200 END:DAYLIGHT END:VTIMEZONE BEGIN:VEVENT CLASS:PUBLIC CREATED:20240306T141950Z DESCRIPTION:Designing Tomorrow’s ATMP Facility: How to Leverage Emerging Technologies\n \nAdvanced therapy medicinal products (ATMPs) are breaking the boundaries of possibility for modern medicines\, but they are also dem anding innovation from the biopharma industry in every way—including in the facility’s design. The ATMP manufacturing process is highly complex and riddled with variability\, making everything from equipment quantity n eeds to minimum facility size difficult to determine. Overinvest and you r isk driving up your cost of goods\, underinvest and you risk operational b ottlenecks with limited treatments for patients\, so how do you right-size your operations?\n\nWith improvement in computing power\, Modeling and Si mulation techniques can be better employed to address the above-mentioned concerns. Computer modeling and simulations from an operational perspectiv e can support the development of an optimal facility design along with dev eloping operating strategies that will enable cell therapy manufacturers t o meet the needs of patient populations\, while better managing product qu ality and\, subsequently the cost of goods.\n\nIn this session\, Niranjan Kulkarni\, Ph.D.\, and Nicolas Bahler focus on two case studies where simu lations drove the design for significant client wins. In the first example \, they will share how they employed Discrete Event Simulations (DES) to r ight-size resource requirements to inform the design of an ATMP manufactur ing facility. In their second example\, they will demonstrate how a Comput ational Fluid Dynamics (CFD) model saved significant CapEx for another cli ent. Their real-world examples will be accompanied by strong visuals and l essons learned.\n\nLearning Objectives:\n\nUnderstand which modeling techn ique to use for specific problem instances.\n\nLearn how to improve facili ty design using operational models and computer simulations.\n\nAssimilate how to maintain these models as the process matures over time.\n \n \nSpe aker\nNiranjan Kulkani\, Senior Director\, Consulting Services\, CRB\nNico las Bahler\, Bioprocess Engineer SIM\, CRB Germany GmbH\n DTEND;TZID="W. Europe Standard Time":20240610T110000 DTSTAMP:20240306T141950Z DTSTART;TZID="W. Europe Standard Time":20240610T103000 LAST-MODIFIED:20240306T141950Z LOCATION:Frankfurt Messe\, Hall 3 Facette PRIORITY:5 SEQUENCE:0 SUMMARY;LANGUAGE=en-us:Designing Tomorrow’s ATMP Facility: How to Leverag e Emerging Technologies - Niranjan Kulkani\, Nicolas Bahler TRANSP:OPAQUE UID:040000008200E00074C5B7101A82E00800000000004BA1F9D76FDA01000000000000000 0100000002FB5AADD46A5B045960013FE4D03BDFB X-ALT-DESC;FMTTYPE=text/html:

Designing Tomorrow’\;s ATMP Facility: How to Leverage Emerging Techn ologies

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Advanced therapy medicinal pro ducts (ATMPs) are breaking the boundaries of possibility for modern medici nes\, but they are also demanding innovation from the biopharma industry i n every way—\;including in the facility’\;s design. The ATMP man ufacturing process is highly complex and riddled with variability\, making everything from equipment quantity needs to minimum facility size difficu lt to determine. Overinvest and you risk driving up your cost of goods\, u nderinvest and you risk operational bottlenecks with limited treatments fo r patients\, so how do you right-size your operations?

With improvement in computing power\, Modeling and Simula tion techniques can be better employed to address the above-mentioned conc erns. Computer modeling and simulations from an operational perspective ca n support the development of an optimal facility design along with develop ing operating strategies that will enable cell therapy manufacturers to me et the needs of patient populations\, while better managing product qualit y and\, subsequently the cost of goods.

In this session\, Niranjan Kulkarni\, Ph.D.\, and Nicolas Bah ler focus on two case studies where simulations drove the design for signi ficant client wins. In the first example\, they will share how they employ ed Discrete Event Simulations (DES) to right-size resource requirements to inform the design of an ATMP manufacturing facility. In their second exam ple\, they will demonstrate how a Computational Fluid Dynamics (CFD) model saved significant CapEx for another client. The ir real-world examples will be accompanied by strong visuals and lessons l earned.

Learning Objectives :

Understand which modeling technique to use for specific problem instances.

Learn how to improve facility design using operatio nal models and computer simulations.

Assimilate how to maintain these models as the process matures o ver time.

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Speaker

Niranjan Kulka ni\, Senior Director\, Consulting Services \, CRB

Nicolas Bahler\, Bioprocess E ngineer SIM\, CRB Germany GmbH

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