Event: Adopting Continuous Manufacturing – Defining the Platform for Success
Supported by: SSPC
In Association with: AIChE, IDA, IchemE, IEI, ISPE, PMTC, SFI
Date: 22-23rd February
Location: Druids Glen, Newtown Mount Kennedy, Co Wicklow
Continuous Manufacturing (CM) and the change from batch to continuous manufacturing offers opportunities in efficiency, flexibility and cost savings for manufacturing facilities, however the technology and processes required to comply with regulatory standards are only now maturing to the point of achieving widespread acceptance in the industry. Here in Ireland we are fortunate to have the SSPC and PMTC at the forefront in understanding these challenges and available to offer guidance and support to Irish based companies who seek to introduce CM processes and technologies
The FDA have been encouraging investment in Continuous Manufacturing for a number of years and a number of pharmaceutical products being produced using CM have received FDA approval in recent years. Eli Lilly in Kinsale announced an investment in April 2016 of €35million to establish a worldwide center of excellence for continuous manufacturing for active pharmaceutical ingredients (APIs) in Cork. This investment in time and effort by Eli Lilly in Cork is a clear indicator that Irish facilities can play a leadership role in the global transition and adoption of this technology.
LSC are delighted to be exhibiting at the upcoming workshop on the 22-23rd February, supported by the SSPC, on Adopting Continuous manufacturing. This is an opportunity to hear from industry professionals, academic experts and government agencies on where they see the opportunities and challenges of introducing CM.
This CM workshop, supported by the SSPC, is the second in a series following the US-based FDA-AlChE workshop in March 2016.
Adoption of CM has been encouraged by regulators in most regions. Implementation within existing batch facilities has posed challenges that require proactive steps to make this adoption a reality. As such, pharmaceutical sites in Ireland play a key role in facilitating CM adoption. Coordinating the industrial and academic sectors in Ireland with the broader global regulatory community is necessary for this wide scale evolution to occur.
It focuses on specific elements needed to successfully deliver continuous manufacturing projects for API, such as:
• Regulatory considerations; expectations for filing and process validation across the product lifestyle
• Control strategy and opportunities for process control, including application of PAT
• Industry/academic collaboration for shared learning and to address open questions.
Breakout sessions involving all parties will discuss open issues and seek progress towards solutions as the workshop proceeds. A tour of a live operating continuous manufacturing facility is included in the program.