How biopharma is accelerating biopharmaceutical R&D
In March 2018, myself (Dr Vishal Sanchania) and Synthace CSO (Dr Markus Gershater) attended the BioProcess International West Conference in San Francisco. This article summarises our 3 key take-home messages from what was an exciting 2-days of talks, meetings and product demos.
Integrating bioprocessing principles and teams with the discovery function is crucial to accelerating the drug discovery process
There’s a big push to accelerate the discovery processes through to clinical proof-of-concept as fast as possible. Current R&D investments and timelines are unsustainable given the ever-increasing competition from generics, as well as a need to demonstrate an increasing patient benefit. This crisis in R&D productivity has been thoroughly summarised by Kevin Stott in this End Points article.
The industry is moving to mitigate the increased scientific (technical) risk of more complex and specific products, as well as accelerate the therapeutic discovery process. One way is by breaking what were often artificial silos between discovery and process R&D, integrating bioprocessing earlier into the discovery cycle.
To enable this, the biopharmaceutical industry is continuing to leverage the use of scale-down models and high-throughput automation, with some teams seeing time reductions of up to 86% by investing resources into such methodologies. Furthermore, by targeting biomolecule product quality earlier within discovery processes, additional time savings are realised later in the R&D process – e.g. looking beyond the titre.
Data remains a challenge
Process Analytical Technology (PAT) systems for dynamic real-time monitoring are continuing to see wider application within regular processes and are helping make processes more efficient. This is also creating a secondary problem – what to do with all the data created.
There is an increasing need for solutions to structure, analyse and leverage data being generated via these new PAT tools. Most companies have traditionally focused on building their own in-house solutions but are now finding that these don’t scale well – in essence, these are solutions for yesterday rather than tomorrow.
Whilst attendees were also keen to explore new technology solutions, they expressed disappointment over previous IT systems which had often delivered little value vs the promises made – in some cases the promised systems being little more than an expensive excel plugin.
Single-use systems offer real benefits
Single-use bioreactor systems, centrifuges, downstream purification systems, etc. are accelerating tech transfer processes. As all hardware is directly “out of the bag”, scaling processes across sites are less likely to suffer hardware specific translation issues. There is now also more customer demand for single-use product manufacturers to work more closely with bio-manufacturers, and many view these two aspects of the industry rapidly converging.
At the end of April, Bioprocess International comes to Amsterdam for their yearly European summit. Here at Synthace, we are excited to see how the ecosystem seeks to address these challenges. Furthermore, as a sponsor of the event Synthace will also be giving a presentation on how next-generation IOT/automation technologies such as our Antha software platform can help accelerate bioprocessing.