Optimizing cell and gene therapy performance
Advanced therapies, including immune cell and stem cell-based therapies as well as viral vectors for gene therapy applications, are currently some of the most sophisticated therapeutics in development. At the scientific forefront of medical research, cell and gene therapy offers an attractive alternative approach to more widely used treatment options. However, the area faces challenges on several fronts, such as upscaling, logistics and ensuring consistent performance. Consequently, there is a need to optimize cell and viral vector performance to achieve a viable product and safe therapeutic solution to patients.
Recombinant human albumin for stem cell culture, cryopreservation & formulation
Albumin is a long-established ingredient of cell culture media, well known to facilitate growth of many cell types, such as mesenchymal stem cells (MSC’s), embryonic stem cells (ESC’s), induced pluripotent stem cells (iPSC’s) and immune cells.
The exact role of albumin in cell culture is not fully established, however after decades of use, its relevance and benefits in cell therapy applications cannot be disputed. Today, several of albumin’s biological properties have been proven valuable across the cell therapy value chain, including:
- Transportation and complexation with metals or other beneficial molecular entities, creating an optimal micro-environment for sustained cell viability.
- Acting as a rich nutrient source ensuring optimal conditions, particularly during cell proliferation.
- Functioning as a pH buffer to prevent unwanted effects during differentiation.
- Maintaining cell viability during cryopreservation - driven by the high purity of our recombinant albumin.
- Acting as a scavenger of toxins and other reactive oxygen species, albumin protects cells against chemical stress all the way from culture to patient.
- Providing an insulation effect in media due to its propensity to distribute evenly throughout solutions.
The actual function of albumin in cell culture, cryopreservation and stem cell formulation is believed to be a combination of these properties. Our recombinant human albumin products (Recombumin®) has been specifically developed to enhance these functional properties – giving you more confidence in your cell therapy.
Read more about albumin in cell therapy in our webinar or whitepaper (Bookshelf)
Recombinant human albumin for virus based therapies
The inherent properties of albumin provide a range of benefits within the development of gene therapy drug products and can take the industry some of the way in overcoming the obstacles ahead however, moving to a recombinant albumin source can in this therapeutic application truly provide the benefits required to take us over the line and unlock the life-saving potential of these therapies.
Challenges which currently faces the industry include the need to produce larger volumes of doses at higher concentration without compromising safety, efficacy, purity, stability and batch-to-batch consistency – Challenges which are especially difficult given the natural diversity of viruses.
- Increase the overall production yield by reducing losses during downstream processing
- Provide a safer dose control in the formulated product by minimizing losses on the container surfaces
- Prevent surface-induced denaturation, thereby cutting the risks of reduced efficacy and increased immunogenicity
- Prevent aggregation or changes in higher order structure during manufacturing, handling and final formulation by protecting fragile particles from shear and temperature stresses, contributing to maintain potency and efficacy.
- Protects viral drug products against oxidative modifications by reacting with aggressive oxidizing species via its free thiol group on cysteine 34 (C34).
As the industry continues to develop and larger patient populations are being addressed the complexities in the manufacture and formulation of these viral therapies will only increase. Albumedix recombinant human albumin products removes some of these complexities by providing a consistent, safe and optimized albumin source.