Education Sessions

E-MG4
Disposables

6 November 08.15-11.30 Track: Manufacturing

ISPE CEUs: 0.2

Focus on implementation issues for disposable technology, considering both practice today and issues that will impact biomanufacturing tomorrow:

  • What is the impact of implementing disposable technology and equipment on qualification and validation?
  • What are the current and future issues in operations where disposable technology is not just being used, but becoming more the norm than the exception?
  • How do you determine the right scale of operation for disposables vs. fixed traditional equipment?
  • What are the pros and cons of single-use items in a multi-product scenario?
  • Of particular interest is the question, “Can you have a totally disposable manufacturing operation?”

Focus on specific case histories of: changes to unit operations and design especially in purification and DSP); movement away from a fixed approach; novel techniques, such as dilution in line; cost savings, or the contrary; reduced delivery and start-up resulting in earlier product release; reduced start up and cleaning validation requirements; reduced clean utility use and hence requirement for smaller systems; and PAT (process analytical technology) applications.

The ultimate transformation is a process that uses only disposables and has no fixed equipment or hard piping. Is this a realistic endpoint and can it be done today? Which processes are suitable for exclusive use of disposables? What are the obstacles and what is necessary to surmount them? The discussion includes well-known limitations, such as mixing for hard-to-dissolve reagents and lack of rapid heat transfer. Focus on issue resolution, as well as solutions for problems identified above.

Take Back to Your Job

  • Recognize available options in disposable/ singe-use equipment
  • Evaluate your process for implementing an operational platform that includes disposables
  • Understand current costs and product information to evaluate options existing today

Who Should Attend

Process and equipment engineers, process scientists, quality control, regulatory, and manufacturing personnel involved in process development and manufacturing initiatives.

Communities of Practice: Active Pharmaceutical Ingredients (API), Biotechnology (BIO), Disposables, Investigational Products (IP), Process/Product Development (PPD), and Project Management (PM)

Session Leader

  • Miriam Monge, VP Marketing & Disposables Implementation, Biopharm Services Ltd.

Session Speakers

 

Sponsors