Advanced therapy medicinal products – a new era of medicine
Biopharmaceutical end-to-end solutions
“End-to-end solutions”, a term and approach first employed in IT, have successively found their way into many other sectors such as the biopharmaceutical industry.
Here, end-to-end solutions 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 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 said silo mentality that is still predominant in so many areas and industries. It is time to increase rationalization processes and to eliminate the risk of product loss. The industry requires comprehensive, intelligent and cutting-edge systems to cover the entire cycle all the way. This includes primary packaging to protect the product throughout its journey and to minimize the risk of contamination.
The need to bridge gaps
Where end-to-end solutions have the obvious and undisputable benefit of being adaptive and flexible, this exact benefit may come as an initial challenge. A complex – and often rigid – process needs to be dismantled in order to shape it into something new and flexible. This takes dedication and time when especially the latter is usually scarce.
Additionally, there is a severe technology gap in the interface between downstream and fill & finish, both of which are crucial steps in the biopharmaceutical production chain. With these two areas being geographically detached, a reliable, high-level handling of bulk drug substances has to be a prerequisite.
Risk of human error and faulty equipment
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.
Flexible and agile development, production and logistics processes
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 a thoroughly though-through, 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.
The solution: Different platforms for different needs
Based on the BULK.STREAM platform, Single Use Support have developed highly flexible and scalable end-to-end solutions for several purposes – industry leading examples for what a progressive and holistic development approach can achieve.
While the BULK.STREAM enables labs and manufacturers to store and ship valuable high-quality substances of practically any volume in a secure and reliable manner, their CGT.STREAM is designed for small batches that are required in advanced personalised therapies. Their SEED-STREAM, on the other hand, is specifically geared towards cell culture intensification.
In line with the definition of end-to-end and its inherent single-use architecture, all three platforms 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.
BULK.STREAM is the connecting step between the downstream- and the fill and finish process, incorporating the integrity testing as well as the disposal of the single use bags. It starts with the drug substance, generated by the downstream applications, and it ends with the defrosted, thawed drug substance at the fill and finish space.Johannes Kirchmair
Solutions such as Single Use Support’s BULK.STREAM, CGT.STREAM or SEED.STREAM allow for a great level of flexibility and scalability when applying predefined actions during the entire drug substance logistics process or sub-steps like the nurturing of cells.
They are offering an elaborate end-to-end platform on the basis of a closed system that covers everything from filling and filtration to the freeze/thaw process and shipping. This allows customers to reduce human error to a minimum thanks to its controllable automatic design and with the substances being protected by single use bags throughout their journey.
Click here to download case studies and information for our end-to-end solutions.
- 1.Ph.D. Hartigan J, Downey W. CMOs Dominate Fill-and-Finish Operations. Genetic Engineering & Biotechnology News. https://www.genengnews.com/magazine/158/cmos-dominate-fill-and-finish-operations/. Published May 15, 2011. Accessed February 8, 2021.