Irwin Hirsch

With Single Use and Disposable Technology adoption growing more commonplace across the biomanufacturing space, now is the time to ensure that your process development strategy and equipment will support your product development, not stand in the way. This workshop will focus on maximising the opportunities presented by single use and disposable solution adoption, whilst identifying and proactively mitigating against the risks involved through process design strategy formation, quality assurance and the environmental impact factors.

Part 1: Identify the opportunities and mitigate against the risks as a Disposables User with an in-depth analysis into:

·      Risk Mitigation strategies and lean manufacturing processes to reduce cost

·      Disposables Lifecycle management

·      Regulatory Framework requirements and challenges

·      Extractables and Leachables impact minimisation and process validation     

·      Particulate presence and mitigation techniques

Part 2: Analyse the applicability of Single Use Technology for Continuous Processing

Define the realities of continuous processing: Is this just a buzz word? What do we actually mean?

Identify the key concern in disposable utilisation: Feasibility of SUT for Chromatographic Processes

Discuss the realities for SUT in continuous processing across upstream and downstream processes

Map out a plan to future adoption: examine where are we now and discuss where we want to go with continuous processing adoption and what we need to achieve to do this