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2022 ISPE Annual Meeting & Expo

SES114 - Concurrent Session: Challenges and Opportunities in Plant to


Oct 31, 2022 3:30pm ‐ Oct 31, 2022 5:00pm


Description

Innovation in challenging times has reshaped the global pharmaceutical manufacturing supply infrastructure. The speed and scale of investment into pharmaceutical industry manufacturing capacity brings novel advances to new modalities and digital solutions and with those innovations come challenges with implications for manufacturers worldwide. An integrated and collaborative project execution approach involving various internal and external stakeholders is required to overcome these implications.

This Session will recognize ISPE FOYA 2022 Award Winners in the Pharma 4.0, Supply Chain, Social Impact and Project Execution categories. Takeda’s TaSiVa project exemplifies how the application of innovation in advanced digital technologies leads to improved outcomes in terms of safety, product quality, and productivity in a pharmaceutical manufacturing facility. Takeda has demonstrated the industry’s ability to use IoT solutions to bring manufacturing rights to the patient to overcome shelf-life challenges which may be presented with new and novel products in the coming years.

Janssen is a J&J biopharmaceutical production and laboratory testing facility who utilized its existing vaccine launch facility (VLF) for an opportunity to enable large-scale COVID-19 vaccine drug substance manufacturing by building a new, 25,000 square-foot sterile manufacturing facility adjacent to the existing VLF. This presentation will describe the current manufacturing capacity environment, explain the new modalities and the processes involved in their production, their supply to patients, and provide a perspective on how the industry can most effectively reallocate capacity and future-proof facilities. This was critical to resolving an unmet medical need during the COVID-19 pandemic by providing the world with a single shot COVID-19 vaccine available on a not-for-profit basis for emergency pandemic use. An integrated and collaborative project execution approach involving various internal and external stakeholders was required to meet these challenging deadlines.

Syntegon presents a case study that expresses how the number, speed, and scale of manufacturing investments in these COVID-19 vaccines reflect both the proven potential of ATMP modalities as well as the vast implications for bio-manufacturers as they seek to simultaneously meet current demand and future-proof their manufacturing infrastructure. Syntegon discusses the new modalities, describes the specific processes involved in their production, and provides a perspective on the challenges involved in, and solutions needed for, successfully adapting today’s manufacturing infrastructure.

Speaker(s):

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