Post-Event Overview: 5th Disposable Solutions for Biomanufacturing Conference



Arnaud Scmutz
05/08/2013

Pharma IQ’s 5th annual Disposable Solutions for Biomanufacturing was held in Brussels Feb 19thand 20that a nice venue near Zaventem terminals.  The speakers and the audience contributed to animated sessions and round tables, as well as exchanges of experiences across the industry. Sourcin supported the event and presented in a session dedicated to knowledge management the requirements to support single use implementation. Sourcin’s presentation was entitled “Knowledge Management On-the-Job: Optimising Biomanufacturing “Soft Skills”.

 

The Chairman Mr. Jerold Martin opened the 5thDisposable Solutions for Biomanufacturing Conference with “Single Use, What’s next?”

“Innovation, cost reduction and standardization” are important topics which the speakers addressed at the conference. Much of them are rooted in the need for more flexibility and compliance to fulfill the BioPharma production paradigm shift that occurred in the past decade. Single use is heavily contributing to it.

Since its inception the single use items moved from basic applications, mainly fluid transfer, to more sophisticated ones. Such quantum leaps allowed the industry to benefit from the use of bespoke devices or standardized items to produce with more flexibility albeit in compliance to the requirements of the Authorities. Therefore, production has adopted and implemented single use equipment for state-of-the-art medicines. Yet the journey is not over, considering the shop floor facing more complex handling, scale out and daily operations requiring special attention, not to mention the foreseeable next paradigm shift in production with personalized medicine and ultra-scale down.

The implementation of single use in production has significant changes in the way processes are conducted. The new applications for instance mixing, bioreactor and purification require full attention to ensure proper use. Actually single use device should be considered as pre-fabricated units that require set up prior to use. Similar to IKEA model, the industry personnel has to “assemble” the pre-fabricated item prior to its use for a specific application. As a consequence, knowledge and know-how are required to complete proper set up. Such pre-fabricated items require manual operations at the start of production processes.

“Soft skills are personal attributes that enhance an individual's interactions, job performance and career prospects” Wikipedia. Sourcin is focused on providing tutorials irrespective of language to support instructions for on-the-job activities or training exercises, thus perfecting production operations. Such a toolbox complements the existing procedures in place by translating instructions into enhanced videos, leveraging compliance and robustness of a given fabrication process. Watching Sourcin’s mediabooks triggers shop-floor personnel attention in a very effective way. It anchors specific know-how hence strengthening the Biopharma production intangibles.

Sourcin presentation at the IQPC 5th conference was illustrated by Mr. Herman van Herk sharing with the audience how Crucell, through the implementation of Sourcin Mediabooks at multiple sites, was able to minimize variability in its operations.

During the same session, Mr. Alain Pralong, Vice President New Product Introduction and Industrialization at GlaxoSmithKline biologicals, depicted how the implementation of new technologies requires comprehensive training to ensure compliance hence knowledge management is of essence to production flexibility and compliance in the Biopharma industry.

This year conference held in Brussels provided as well good networking and we look forward to next year’s event.

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