Amongst the companies providing fodder for booth trophy hunters, national dancers, alphorns and buckets of beer, what was one of the big buzzes at BIO 2012? Bioprocessing. Last year this area was just a zone, but it has fermented into a healthy biomass of hundreds of large molecule therapeutics, antibody and vaccine CMOs. Not just the Lonza, DSM and Xcellerons but many, many more providers of bespoke biologics manufacturing were there. This was no Pittcon but the amount of stainless steel and bio manufacturing expertize was the largest ever.
So, how come this growth-based industry is growing so fast? The FDA has fed the growth by its Quality by Design (QbD) requirements, backed up by some recent high profile fines for major pharma batch failures. Coupled with the rise in large molecule therapeutics, vaccines and biosimilars the momentum is unstoppable.
But there is still a big problem brewing in fermenters around the world….data overload. Bioprocess development and QA produce mountains of process and scientific data. This data is vital in building recipes that provide consistency of production and to compare today’s yield against historical data, to take decisions and share them with others. Amazingly many of these processes are still paper driven and laborious, so the impact for a low margin CMO, seeking to attract business and keep the FDA happy, is clear. Go digital and get efficient. This is not a transactional ‘BI-like’ aggregation of dispersed data but an integrated, managed data approach.
When developing a process and undertaking experimental design, each step needs to be captured, compared to historical data, and integrated with other data to secure IP and provide process insight. Into this data-rich environment step GMP-compliant process ELNs such as IDBS’ E-WorkBook which is both a research ELN and Process Execution System, able to cross the boundary of R&D. Coupled with Design of Experiments systems such as uMetrics, and internal historian systems, these platforms are able to capture, compute, compare and secure process data; then integrate upstream to Manufacturing Execution Systems (MES) and Enterprise Requirements Planning Systems such as SAP.
The bioprocess development process has been very document-driven and this is hugely inefficient. Documents should be generated just in time rather than generating data from multiple documents. This is where data management takes over from legacy document/paper management. Fast-moving Bioprocess organizations’ process engineers now inhabit a flexible, cheaper data-driven world with documents generated on demand, rather than living in a document heavy environment.
There was plenty more at BIO 2012 but for sheer biomass at BIO in Mass the Bioprocess team wins. With improved data management and associated process insight these companies will expand further to become major league players providing cheaper, better therapeutics in the decades to come.