BIO
Single-use technologies are enabling the biopharma industry to keep up with increasing demand for biologics
The biologics market is exponentially increasing in size, having exceeded US$264 billion in 2021, and is expected to double by the end of 2023. With this increase, research into treatments of diseases has resulted in the development of a wide range of novel therapeutics such as:
- Gene therapy viral vectors
- Cell therapies
- Oncolytic viruses
- Messenger RNA (mRNA) vaccines
- Prophylactic vaccines of diverse modalities
- Proteins and monoclonal antibodies (mAbs).
With multiple healthcare systems now benefiting from these therapeutics, demand is growing, and drug development pipelines are quickly filling with advanced therapy medicinal products (ATMPs). As a result, contract development and manufacturing organisations (CDMOs) are having to facilitate scaling up the production of these biologics to meet demand. Recent improvements by drug delivery device manufacturers in single-use technologies (SUTs) have enabled biologics scaling with increased flexibility and facility investment savings.
SUTs are being integrated into upstream and downstream biological manufacturing to enhance and accelerate the production power of biologics. One big advantage is that the use of SUTs minimises the risk of cross-contamination. With increased interest in personalised medicine (one batch per patient) and cell and gene therapies gaining momentum in the biopharma space, reducing the risk of cross-contamination during the manufacture of ATMPs is vital.
Upstream scalability challenges
Scalability challenges predominantly concern upstream bioreactor scale-up and surround challenges associated with the chosen host cell line — as its characteristics and performance indicators will need to be considered when scaling up and down.
There are several important notes to consider when scaling processes for biologics production and with advancements in SUTs, the adoption of these technologies is highly likely to increase. To tackle challenges, manufacturers need to understand all process parameters that could be affected at different stages of production and decide whether scaling out or up is the most appropriate action.
Dr. Kai Lipinski, Chief Scientific Officer at ReciBioPharm explores this topic further in an article with Contract Pharma magazine.