Explore the Future of Pharmaceutical Production
How do we incorporate the new technologies of Single-Use and Continuous Processing?
What can be done to make factories more flexible and efficient?
What types of new features can be expected in devices and what challenges may occur?
The 2016 ISPE Annual Meeting & Expo Product Development and Production Systems Track will answer these questions and more, as well as provide a glimpse of the future of pharmaceutical production over the next ten years through these interactive sessions: Real Life Benefits from Process Closure
This presentation seeks to explore the application and benefits of closed processing, and provide a pragmatic framework for decision making when designing a new manufacturing facility.
Single-Use Technology Assessment & Implementation via Retrofit of a Clinical Manufacturing Facility
Learn how GlaxoSmithKline’s Clinical Manufacturing Facility in Upper Merion, PA was renovated to establish a global manufacturing platform strategy for scale out with 2000L Single-Use Bioreactors (SUBs)and addressed the challenges of transforming an existing clinical manufacturing facility with the constraints of the existing building and avoided a full facility shutdown.
Engineering Solutions for OSD
Multiple session options will be available to expand your knowledge on OSD manufacturing including a continuous OSD manufacturing overview, PAT and lessons from the NEW OSD Baseline Guide, Vol. III.
Real Time Release Testing: How IT Systems Support the Process Control Strategy
The session will start with an overview of the today's systems architectures and will show best practices through case studies on how IT Systems are supporting the Process Control Strategy Execution.
Production of Orphan Drugs
With the introduction of The Orphan Drug Act (ODA) the manufacturing of orphan drug and biological products have become increasingly demanding. Speed to market, small batch sizes and aseptic manufacturing are among many of these challenges. This session addresses how manufacturers, suppliers and end users are reacting and preparing themselves to meet this increasing demand.
Injection-Pens, Autoinjectors, and Combination Products
Prefilled syringes, cartridges, autoinjectors etc. now have to be submitted as combination products. This means that a medical device certification is also needed. Also, autoinjectors and pens are on one hand smart, advanced and easy-to-use devices, but also have some challenges in design and manufacturing. This session will show the state of the art with these systems in developing, qualifying and marketing them successfully.
Aseptic Technology and GMP Quality Systems for the Compounding Industry
With the advent of The Drug Quality and Security Act in 2013, new regulations were promulgated for 503B outsourcing compounding pharmacies to provide medicines in small batches. This legislation was required after a tragedy occurred due to fungal contamination in steroid injections made by the New England Compounding Center. This session will face the challenge of bringing APPROPRIATE advanced aseptic processing and facilities, plus GMP quality systems, to this new sector of the industry.
Flexible Continuous Processing Retrofit
This session will cover how to repurpose existing batch operations with a continuous processing plant to improve safety, manufacturing capabilities, and support investigational manufacturing supply strategy. Additionally, increasing the capabilities of the existing infrastructure and maintaining an operating facility will be addressed.
In addition to the exceptional education sessions, don't miss out on these networking opportunities to meet pharmaceutical and regulatory industry professionals:
- Sunday Welcome Reception
- Young Professionals Event
- GAMP 25th Anniversary Event
- Membership and Awards Breakfast
- Lunches in the Expo Hall
- Tuesday Night Party
- Wednesday Facility Tours
