Pre-Conference Workshop Day
Tuesday February 25, 2025

Pre-Conference Workshop Day

Tuesday 25th February 2025

8:30am Registration & Morning Coffee

9:00am Workshop A

Advancing Tech Transfer for Hybrid Modalities to Meet Deadlines & Deliver Drugs Faster

  • Julie Wei Associate Director, Ultragenyx Pharmaceutical Inc
  • Indu Muthancheri Scientist, Process Engineering & Modeling, Sanofi

Synopsis

Pinpointing continuous failures and troubleshooting can be time consuming and result in downtime. This workshop will ensure you are equipped with the technical knowledge to perfect your small-scale operations and futureproof scale-up to shorten time to market. Delve into tech transfer case-studies for small molecule and small-scale advancements for large biologics to understand how to maintain end-to-end product consistency:

  • Navigating failures and successes to translate into a successful transition to scale with minimal downtime
  • Examining pre-scale gap analysis requirements to match critical parameters at scale for product similarity
  • Shifting from a modular to integrated vision of processing to enable flexibility during production

Breakout Session

Join your peers’ post-presentations to discuss over a series of questions applicable to your area of specialty

Small Molecule

Synopsis

  • How are you advancing your process models to facilitate tech transfer?
  • How to integrate unit operations contributing towards a fully flexible manufacturing line?
  • What are the analytical method transfer approaches being used for small molecules?

Large Biologics

Synopsis

  • How are you advancing your process models to facilitate tech transfer?
  • How to integrate unit operations contributing towards a fully flexible manufacturing line?
  • What are the analytical method transfer approaches being used for small molecules?

11:00am Morning Refreshment Break

11:30am Workshop B

Training to Think in Continuous: Adopting Continuous Manufacturing Cross-Learnings Between Modalities to Translate Across the Complete Pipeline

  • Irina Ramos Director of Bioprocess Technology & Engineering, AstraZeneca
  • Muthu Meiyappan Head of Technology Development & Implementation, Takeda Pharmaceutical Co. Ltd.

Synopsis

  • Developing an internal mindset to embrace continuous processing to enhance cost-efficient production along the pipeline
  • Considering best internal practices to reprioritize continuous manufacturing and build a strong business case for efficient manufacturing alternatives
  • Understanding small molecule applications to be applied to biologics manufacturing to move the needle forward for development 

Breakout Session

Join your peers’ post-presentations to discuss over a series of questions applicable to your area of specialty

Small Molecule

Synopsis

  • What are the technological capabilities required to advance continuous-informed small molecule production?
  • What are some methods of proactive risk management to stabilize the shift to continuous?
  • How to accelerate adoption for all small molecule therapeutics?

Large Biologics

Synopsis

  • What are the technological capabilities required to advance continuous-informed biologics production?
  • What are some methods of proactive risk management to communicate internally?
  • How to accelerate adoption for more biologic therapeutics?

1:30pm Networking Lunch

3:00pm CONTINUUS Pharmaceuticals Site Visit

Synopsis

CONTINUUS Pharmaceuticals is leveraging a novel continuous manufacturing platform called Integrated Continuous Manufacturing (ICM), initially developed through an $85m joint research project between Novartis and MIT. With ICM, they aim to improve affordability and accessibility of pharmaceuticals on a global scale. From facility design to equipment selection, tech transfer to validation, this unique site visit will give you the opportunity to see an ICM facility in person, ask the CONTINUUS Pharmaceuticals team your burning questions in real-time. There will be 2 separate tours running across the day, and has always been a sold-out section for our CCP preworkshop day but places are strictly limited to workshop attendees.

What you can expect?

  • Transportation to and from CONTINUUS Pharmaceuticals from the conference venue
  • Tour of the end-to-end ICM pilot plant and the high potency continuous lab
  • An in-depth presentation on continuous processing and flow chemistry
  • Q&A on technical solutions with the CONTINUUS Pharmaceuticals experts

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Register for the Pre-Conference CONTINUUS Pharmaceuticals Site Visit now