End-to-end solutions in the context of the biopharmaceutical industry are primarily based on single-use technologies, which allow for the greatest flexibility and agility.
Thanks to their versatility, these solutions are set to gain ever more importance and traction in the competitive race to develop new or produce tried-and-tested compounds and bring them to the market respectively to the patient.
In an extremely complex, competitive and constantly evolving sector like the biopharmaceutical industry, end-to-end solutions offer a comprehensive and elaborate logistics approach, at the same time ruling out risks of incompatibility and potential product loss or other damages caused by human error.
They facilitate safe and reliable drug substance logistics processes for highly valuable and sensitive drug substances. Thanks to their flexible nature end-to-end solutions allow for stringing together several process steps, as needed, without subjecting the substances to any form of contamination risk.
As opposed to standalone “silo” platforms, end-to-end solutions can be adapted and scaled to meet specific manufacturer or lab needs.
It is high time to let go of the predominant silo mentality and implement effective processes to eliminate the risk of product loss. The industry requires comprehensive, intelligent and cutting-edge systems to cover the entire cycle all the way.
As is the case in pretty much every sphere of life, the residual risk of human error remains one of the main challenges. Human errors can have far-reaching repercussions.
Several studies confirm that a high number of CMOs and biopharma manufacturers keep filling their products manually - or that they outsource filling altogether - with both cases offering a lot of space and potential for human error and contamination.1
However, it is not only human errors but also faulty equipment that can have enormous consequences for biopharmaceutical companies.
If a batch is lost due to contamination - irrespective of whether it was caused by mishandling or faulty equipment - the manufacturer will likely suffer significant financial losses, but, even more fatally, this can lead to dire consequences for the patient relying on the specific medication.
Based on the idea of maximum elasticity, Single Use Support have reinterpreted basic production and logistics steps to offer flexible and agile solutions to the biopharma industry.
Their BULK.STREAM is a perfect example of an elaborate end-to-end process.
It is comprised of a portfolio of logical process steps that connect downstream and fill and finish to enable a safe and secure transport of high-value drug substance from the manufacturing area to the patient.
Whilst the BULK.STREAM enables labs and manufacturers to store and ship valuable high-quality substances of larges volumes in a secure and reliable manner, all solutions are scalable and can be applied in the CGT.STREAM for low volume batches in cell and gene therapies.
In line with the definition of end-to-end and its inherent single-use architecture, all platform technologies offer the option to be adapted. Be it by adding a number of optional components such as filtration systems or by scaling up/down to larger/smaller volumes and batches.
End-to-End Platform Solutions such as Single Use Support’s BULK.STREAM allow for a great level of flexibility and scalability during the entire drug substance logistics process or sub-steps like the nurturing of cells.
Click here to download case studies and information for our end-to-end solutions.
