March 21, 2022
Scalability of single-use drug substance production
- Scalability around freezing means the ability to guarantee constant stress on proteins (biopharmaceutical molecules) in all scales, filling volumes and loading scenarios.
- Single Use Support fulfils this requirement by standardizing the IFGS – ice front growth speed – for all possible scenarios regardless of the filling volume and type of bags but also regardless of the type of system, i.e. whether RoSS.pFTU Lab Scale or Large Scale.
Batch size volume and load independent homogeneous freezing and thawing results:
(example of freeze/thawing curves of a fully scalable process)
3 liters / pre-clinical or Phase 1/2
150 liters / Phase 2/3 or commercialized
300 liters / commercialized
Freezing kinetics must be practically identical no matter if you freeze 500mL or 200L.Johannes Kirchmair, CEO
It is typical for commercial programs to generate several hundred liters of drug substance per batch.11 In general, the awareness and importance of the gap in bulk drug substance management (between downstream and fill and finish) is steadily increasing. Biopharmaceutical companies are willing to invest more in relevant technologies. This shows that securing the highest possible standard is not only important in terms of efficiency, but also in order to safeguard high-quality products as a responsibility towards patients.12
[Sources from the SUS_ebook_Rev. 1]
Click here to download ebook, case study scalable fast freezing.