Highlights from Aseptic Track at 2019 ISPE Aseptic Conference
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:
Recent transformation projects, where moving from stainless steel to disposables has helped to de-bottleneck operations
Advances in fluoropolymer films that help solve problems with leaking bags, while the material can be gamma-sterilized for the first time – a case study on validation challenges and how to solve them in the area of fill/finish
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.
What is the Route to Successful ATMP Cleanroom Development?
Mitch Gonzales, Vice President of Process Technology and Grant Merrill, Chief Commercial Officer at AES Clean Technology, explore the unique aseptic processing needs of advanced therapy medicinal products (ATMPs) and explain the ideal pathway to successful cleanroom design for this class of therapies.
The ISPE Facility of the Future Conferences can feel like a crystal ball looking into the future . Year after year, speakers have presented what the future of the industry may look like, and then, in subsequent years, speakers will present how they have implemented that future. It is remarkable to see the future come to fruition and learn how others are navigating it. One of the greatest...