in-house event – RheaVita

Hands-on training on fast product and process development for continuous freeze-drying of biologics, ATMP’s and LNP based formulations May 10-12

For the third time RheaVita organizes its famous Lyo course!

We welcome everyone at our new location in Ghent for 3 days filled with mainly new insights, presentation of the latest developments and the possibility to network with peers in the picturesque city of Ghent.

For this year we have decided to focus on how you can achieve fast formulation and process development with limited amount of materials using the RheaVita continuous freeze-drying single vial unit.

Participants will be given hands-on training.

We will present in detail the continuous freeze-drying process, how to make use of PAT tools to monitor and actively control your product and process from R&D to production, and how to number up from lab development to GMP production by using continuous freeze-drying technology.

The hands-on applications will include biologics, ATMP’s and LNP based formulations. Case studies will be presented by Coriolis and Etherna.

The hands-on applications will be based on biologics, ATMP’s and LNP based formulations. Case studies will be presented by Ghent University, Coriolis and Etherna.

Price:

Industry: €1500 → Early bird: €1000
Academic: €750 → Early bird: €500
Students: €500 → Early bird: €250

Prices are excl. VAT

Early bird rates apply until April 15th

Frieda Saeysstraat 1
B-9052 Zwijnaarde
Belgium

Agenda & Speakers

Agenda:

Day 1: Continuous and controlled freeze-drying
- 13h00 – 13h30: Registration + coffee
- 13h30 – 14h00: Introduction & setting the scene
- 14h00 – 15h30: RheaVita’s continuous & controlled freeze-drying technology:
  - Introduction
  - Continuous freeze-drying as part of entire production chain
  - Flexible production volumes through numbering-up concept
  - Basic and fundamental principles of spin-freezing, sublimation and desorption
  - Condensorless system: Enabling the fast freeze-drying of formulations with low collapse temperatures
- 15h30 – 16h00: Coffee break
- 16h00 – 17h30: Model based design of RheaVita’s continuous freeze-drying technology:
  - Mechanistic modelling: The fundamentals behind the RheaVita’s continuous freeze-drying technology
  - Validated mechanistic models implemented in user friendly software & digital twins

Day 2: Hands-on training on fast product and process development
- 08h30 – 09h00: Registration + coffee
- 09h00 – 10h30: Fast formulation and process development using RheaVita’s single vial unit (SVU) and software platform:
  - Formulation aspects for optimal continuous freeze-drying
  - Efficient formulation screening and development through
    - fast design of experiments with very limited material consumption
    - model based software supported optimal process setting determination
  - Continuous freeze-drying dynamic design space determination (including DEMO)
- 10h30 – 11h00: Coffee break
- 11h00 – 12h30: Process monitoring and control at vial level during continuous freeze-drying
  - RheaVita’s unique PAT solutions for monitoring and active control at the individual vial level from R&D to production (including end point determination)
  - Improved Quality Assurance: Decreasing defect levels approaching zero
  - RTR from process understanding, control and 100% inspection
- 12h30 – 13h30: Lunch break
- 13h30 – 15h30: The RheaVita Continuous Freeze-Drying Technology as an enabler for biopharmaceuticals and ATMPs: CASE Studies
  - Lyophilization of lipid nanoparticle-formulated mRNA vaccines (Mr. Alexander Lamoot; Ghent University)
  - Freeze-drying of LNP’s (Dr. Dakwar; Etherna)
  - Development and optimization of a continuous freeze-drying process to enable the long-termstorage of mRNA lipidnanoparticles (Mrs. Sofie Meulewaeter; Ghent University)
  - What is the impact of Impact of Formulation Composition and Process Settings of Traditional Batch Versus Continuous Freeze-Drying On Protein Aggregation (Dr. Brecht Vanbillemont; Coriolis)
- 15h30 – 16h00: Coffee break
- 16h00 – 17h30: Bringing the theory into practice
  - Hands-on fast formulation and process development by participants using RheaVita’s SVU and software platforms by means of formulation case studies
- 18h30 – …: Networking event

Day 3: Towards continuous freeze-drying GMP production
- 08h30 – 09h00: Coffee
- 09h00 – 10h30: Fast transfer from SVU to GMP-Flex
  - Presentation of RheaVita’s GMP-Flex technology
  - Creating identical process conditions at vial level from R&D to production scale continuous freeze-drying using RheaVita’s unique active PAT based control solutions
  - Continuous freeze-drying and pharmaceutical manufacturing container technology
- 10h30 – 11h00: Coffee break
- 11h00 – 12h30: Continuous Freeze-Drying in GMP facility
  - Presentation of RheaVita’s GMP-Flex system GMP aspects (CIP/SIP, particle monitoring, rapid change-over…)
  - Flexible volumes
  - Continuous freeze-drying production scenario’s
  - Presentation of detailed business cases (OPEX, CAPEX, carbon footprint, E-consumption,…)
- 12h30 – 12h45: Introduction to hands-on GMP event (Q4 2022)
- 12h45 – 13h30: Lunch break and goodbye