adapting drug product manufacturing strategy & processes for ready-to-use (rtu) vials, syringes...
TRANSCRIPT
Adapting Drug Product Manufacturing Strategy & Processes for Ready-To-
Use Vials, Syringes & CartridgesJosh Russell
Life Sciences Product Manager, AST
Parenterals & Injectables Conference 2015
Exploring the Challenges in Parenterals and Injectables: Manufacturing & Sustainability
Presentation Overview
Exploring the Challenges in Parenterals and
Injectables: Manufacturing &
Sustainability
Changing Parenteral Market
Adaptive Manufacturing
Leveraging Ready-to-Use
Considerations & Implications
Summary
Parenteral Market Trends
Exploring the Challenges in Parenterals and
Injectables: Manufacturing &
Sustainability
Parenteral Market Trends
Exploring the Challenges in Parenterals and
Injectables: Manufacturing &
Sustainability
Parenteral Market Trends
Exploring the Challenges in Parenterals and
Injectables: Manufacturing &
Sustainability
Pipeline DemandsHigh value therapies, niche products and biosimilars are the products of the current and future focus
• Next generation oncology drugs• Monoclonal antibodies (MABs)• Therapeutic vaccines• Gene therapies• Orphan drugs
• Antigen specific immunotherapies• Adapted dosages forms• Recombinant proteins• Drug combinations• Cell therapies
Smaller Batches
Higher Yield Expectations
Increased Potency
Market Volatility
Higher Quality Expectations
Exploring the Challenges in Parenterals and
Injectables: Manufacturing &
Sustainability
New product demands require a shift in thinking…• High value / low volume batch production
requires us to take new approaches – Lean approaches, adaptive “work cells” or “work
centers”– Maximize utilization, minimize changeover– Standard modular platforms with reduced lead times
and costs vs. traditional systems– Easily transplanted to emerging markets– Adaptive technologies that can be readily customized
to address unique product needs
Exploring the Challenges in Parenterals and
Injectables: Manufacturing &
Sustainability
Traditional Approach
Exploring the Challenges in Parenterals and
Injectables: Manufacturing &
Sustainability
Dedicated brick and mortar productions sites Customized to meet immediate product needs with eye to the future Difficult to retrofit without disruption
Dedicated machinery required for vial washing & depyrogenation Additional cleanroom space required to house the machinery No ability to expand container filling capability (ex. syringe vial) High utility costs
Container quality defects (e.g. glass breakage, bruising, etc.) Product quality risks (e.g. interventions, particulates, etc.)
Traditional Manufacturing Strategy
OR
EXPANSION
Fixed
FixedFixed
++
• WFI• Depyro Tunnel• Cleanroom• Validation• Maintenance
Exploring the Challenges in Parenterals and
Injectables: Manufacturing &
Sustainability
WFI
Adaptive Approach
Exploring the Challenges in Parenterals and
Injectables: Manufacturing &
Sustainability
Modular & “Podular” construction for future adaptation or mobility Smaller, reproducible site design Adapt to future product portfolio requirements
Minimizes equipment requirements to the bare essentials Equipment is process centric, not container focused (lean) Minimal cleanroom footprint Utility and labor savings
Eliminates common quality risks (ex. glass particulation) Eliminates common intervention risks Enables products to be filled in multiple primary container options Adaptive to custom or unique portfolio needs
Adaptive Manufacturing Strategy
EXPANSION
Adaptive Adaptive Adaptive
+
Exploring the Challenges in Parenterals and
Injectables: Manufacturing &
Sustainability
<494 Tons CO2
<58%
Enabling Technologies
Exploring the Challenges in Parenterals and
Injectables: Manufacturing &
Sustainability
• Ready-To-Use (RTU)
• Isolator-barrier technology
• Single use materials
• Robotics
Adaptive Manufacturing leverages four proven enabling technologies to provide a versatile manufacturing platform
Ready-To-Use (RTU)
Exploring the Challenges in Parenterals and
Injectables: Manufacturing &
Sustainability
• Pre-washed & sterilized containers– Vials, syringes &
cartridges– <1 ETU per container
• Packaging eliminates processing challenges– Orientation– Container separation
RTU Anatomy
Image courtesy of Ompi
Image courtesy of Schott
Exploring the Challenges in Parenterals and
Injectables: Manufacturing &
Sustainability
RTU Minimizes Quality Risks
Exploring the Challenges in Parenterals and
Injectables: Manufacturing &
Sustainability
Images courtesy of Ompi
Adaptive RTU Processing• Small & nimble configured
manufacturing system• Standard module options
for common processes• Configure system using
standard modules– Filling, capping, lyo, tub
opening, bag opening, etc.– Can be reconfigured for new
requirements
Exploring the Challenges in Parenterals and
Injectables: Manufacturing &
Sustainability
Adaptive RTU Processing
Exploring the Challenges in Parenterals and
Injectables: Manufacturing &
Sustainability
Processing Considerations• In-Process Checks (IPC)
– In nest vs. out of nest• Accuracy & Repeatability
• Packaging– Static Particles– Sterilization Process
• Effects on packaging– Critical tolerances– VPHP uptake
Exploring the Challenges in Parenterals and
Injectables: Manufacturing &
Sustainability
Processing Considerations• Container Handling
– In the nest vs. out of the nest
– Capping– Freeze drying
• Quality & Regulatory– Annex 1– Track & trace– Interventions
Exploring the Challenges in Parenterals and
Injectables: Manufacturing &
Sustainability
Summary• Rethink traditional aseptic manufacturing options
to determine how well suited for current and future product portfolios
• Adaptive manufacturing provides the nimbleness to address immediate and future portfolio requirements quickly
• Ready-to-use containers reduce total cost of ownership and common product quality risks
• Partnering with knowledgeable experts is key to RTU processing success
Exploring the Challenges in Parenterals and
Injectables: Manufacturing &
Sustainability
Thank you for your attention!
Questions?
Josh Russell, Product Manager – Life SciencesAutomated Systems of Tacoma (AST)4110 South Washington Street Tacoma, WA 98409(253) [email protected]
Exploring the Challenges in Parenterals and
Injectables: Manufacturing &
Sustainability