There are new technology spaces that are impacting or poised to impact how we produce our products in a very significant way. In fact, we are experiencing an explosion of new biologic products coming from our pipeline and need the expensive capacity to generate commercial product. How can we provide these life-saving treatments without always making risky large capital investments?

With the Product Development and Production Systems Track of the ISPE Annual Meeting 2015, you will learn from others on how they have tackled the challenges of the new technologies of Single Use and Continuous Processing, new class of products (i.e. Antibody Drug Conjugates) with significant containment issues, capacity improvement opportunities, new thinking around the established processing of Oral Solid Dosage and delivery of the complex Commissioning and Qualification scope.

Led by Steven Miller, CPIP, Director, MedImmue/AstraZeneca Supply Biologics, this track provides insight into new technologies in Single-Use Technology and Continuous Processing that impact how products are produced, including these key sessions:

  • New Directions in Continuous Processing for MAb Manufacturing
    Discuss the motivations, barriers and enabling technologies to initiate continuous processing in MAb manufacturing
  • Things Your Mother Didn’t Tell You: Lessons Learned from Implementing Single-Use Technology in Scale-Up from Clinical to Commercial Manufacturing
    Uncover the challenges and issues that are not identified during conceptual development of the commercial manufacturing design, yet have a significant impact when they became reality
  • Advances in Next Generation Manufacturing
    Examine new technologies that decrease a manufacturing site’s footprint while lowering cost, improving speed to market and ensuring a more sustainable drug supply
  • PAT in Raw Materials: The Use of PAT Tools and Methodologies to Drive Consistency and Performance Throughout the Manufacturing Process
    Examine the use of Process Analytical Technologies (PAT), in the form of instrumentation and modeling provides an opportunity to detect potential issues with raw materials and to adjust the process to compensate for any abnormal conditions before they become quality and compliance issues

Additionally, the Product Development and Production Systems Track will cover topics such as:

  • Antibody Drug Conjugates
  • Aseptic & Barrier Technologies
  • Facility Capacity
  • Process Modelling
  • Third Party API Supplier Partnerships
  • PAT in Raw Materials

Early bird discounted registration rates are available until 11 October, so register now. For more information about the conference, please visit the conference website www.ISPE.org/Annual-Meeting.

 

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