Gene therapy

Recombinant human albumin for optimizing virus based therapies

At the scientific forefront of medical research, gene therapies including viral vector based technologies and vaccines are offering solutions to previously untreatable causes. As seen with other advanced therapies such as stem cell treatments, developers are facing challenges with regards to optimization, upscaling and logistics.

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.

Read more about albumin in virus based therapies in our scientific blog or library (Scientific Blog or Scientific library)

Enquire about Recombumin®

Please contact bd.nottingham@Sartorius.com for any enquiries.