Introduction:
This article discusses the hidden costs associated with sub-standard recombinant albumin, a key component in vaccine and biopharmaceutical formulations. It highlights the risks of batch-to-batch inconsistency and performance deficits in these products, which can lead to lower gross margins, adversely affected patients, and potential market access suspension. It emphasizes the importance of using high-quality recombinant albumin to mitigate these risks and the need for greater transparency about the safety and performance of different recombinant albumins on the market.
- Product performance deficits can result in lost batches, lower gross margins, and adversely affected patients.
- Recombinant albumin from rice or yeast may contain potentially immunogenic post-translational modifications (PTMs), affecting safety and performance.
- New strains of Saccharomyces cerevisiae for recombinant albumin production offer a safer alternative with controlled PTMs.
- Bespoke optimization of production strains using QTL technology can broaden access to premium-quality albumin at lower prices.
- Transparency about the PTM profiles and associated risks of different recombinant albumins is needed to ensure safe use.
Conclusion:
Sub-standard recombinant albumin can have hidden costs in terms of lost batches, lower gross margins, and potential harm to patients. Using high-quality recombinant albumin, such as that produced from new strains of Saccharomyces cerevisiae, can mitigate these risks and offer a safer alternative to animal-derived albumin. Bespoke optimization of production strains using QTL technology can improve access to premium-quality albumin at lower prices. However, greater transparency about the PTM profiles and associated risks of different recombinant albumins is crucial for ensuring safe use in vaccine and biopharmaceutical formulations.
