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) 475-0200jrussell@ast-inc.com

Exploring the Challenges in Parenterals and

Injectables: Manufacturing &

Sustainability