Aseptic filling of parenterals is one of the most challenging tasks within pharmaceutical manufacturing. There is a wide range of challenges from engineer driven tasks like filling accuracy and machine performance to pharmaceutical key questions like how to keep the process sterile while staying compliant with the regulations and guidelines. All of this is influenced by new process methods and innovations in technology and at the same time trying to remain cost effective and make the right decisions quickly.
At the 2019 ISPE Aseptic Conference, you will learn firsthand from people within the industry who are facing these challenges and how they have dealing with them. The sessions, workshops, networking breaks, and social events give you a unique opportunity to discuss the challenges you’re currently facing and gain some actionable ideas and solutions to improve the manufacturing processes at your company.
For the first time, we will have a session for cell and gene therapy! Production systems for this application are challenging for manufacturing operations as the requirements are different from the traditional aseptic fill-finish process. Production limitations may include the culture of modified live cells and very small batch sizes (one patient/batch), as the therapies are highly specialized. In this session, we will cover case-studies from recently completed projects, including lessons learned and an outlook of what’s to come in the future.
An on-going area of interest is disposable equipment and how it is finding its way into the whole production chain and now conquering the last route, the fill/finish path. Sessions include:
I am honored to be the wingman of our chair, Jörg Zimmermann, for the aseptic track for the 6th year in a row and look forward to connecting with you at the 2019 ISPE Aseptic Conference.
The integration of data science in biopharmaceutical manufacturing, emphasizing data quality, tech transfer efficiency, and process optimization, is the heart of this track. Led by industry experts, discussions explore leveraging digital twins, predictive analytics, and continuous improvement initiatives. Additionally, interactive roundtable discussions provide attendees with a dynamic forum...
The pharmaceutical sector stands at a crossroads of immense possibilities. We are witnessing an unprecedented surge in innovation, fueled by a remarkable partnership between industry and regulatory authorities. For example, there are initiatives fostered by the US Food and Drug Administration (US FDA) to promote innovation with programs such as CATT (CBER Advanced Technologies Team) and ETP...
Through the ISPE Foundation Professional Development Grant program, Silas Tamufor attended the 2023 ISPE Annual Meeting & Expo in October 2023. Tamufor is a PhD student and ISPE Boston Chapter member who began serving as the ISPE Boston Educational Programs Committee Chair in December 2023. He, along with 87 other students and recent graduates, attended the conference thanks to the...