Applications of Single-Use/Disposable Technology in Fill/Finish [Whitepaper]

Bioreactor

Whitepaper Overview:

A range of factors are currently conspiring to push the field of pharmaceutical manufacturing toward wider use of SUSs. While factors specific to the fill/finish stage have meant that it has taken the longest to be affected by such changes, recent developments in the associated materials, technology and regulatory landscape are making possible rapid development on this front. Disposables have the potential to render substantial benefits in respect of savings of time and expense, and enhancements to safety and clinical rigor. All this makes it almost certain that they will see continued growth in the immediate future, and anyone with a stake in the industry would do well to keep a finger on the pulse of this transformation.

The CMO Patheon has installed an entirely disposable fill/finish system that is fully validated, scalable from 2 liters to 200 liters, and meets all requirements in respect of E&Ls.[1] Fill sets of three different sizes were manufactured in collaboration with suppliers. An initial saving of 10% on capital investment was achieved through the implementation of a single-use system, and subsequent continuing benefits include a reduction in personnel hours required for changeover from 19 hours to 1.5. Further, the flexibility offered by SUSs in terms of size means that excess or wasted capacity is greatly reduced, and Tony Pidgeon, senior manager of global science and technology at Patheon, claims, “At this point, whenever we can, we will opt for single-use systems, and single-use technology has become the preferred approach for new facilities.”[1]

A three-way collaboration between Merck, Bausch+Ströbel, and Pall has validated the dosing accuracy of a wetted filling line using single-use needles. Criteria considered in the performance of the filling line included regulatory compliance, compatibility with pre-existing facilities, sterilization, container integrity, and others. During testing, circa 7,500 syringes were filled, with a 0.46% relative standard deviation in dosing, meeting the requirements stipulated.[2] Such successes serve to overcome among the most significant of the impediments that remain to the implementation of disposable in these stages of production, and pave the way for expanded application of SUSs in similar contexts.

Such expansion is evident in the wide range of provisions vendors are now offering in this field. Among the most noteworthy of these is from Mobius, in the form of what it calls an “out of the box” solution: a complete fill/finish system custom-made in collaboration between the producer and Mobius itself in order to tailor it to specific needs.[3] In addition, Mobius provides a service for the installation and set-up of the fill/finish system, and support in its operation. Related and similar products are being formulated at a rapid rate (see [4]), testifying to the shifts occurring in the area.

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References

  1. Cynthia Challener, “Exploring single-use systems for fill-finish operations.” Pharmaceutical Technology, Sep 25, 2013. http://www.pharmtech.com/exploring-single-use-systems-fill-finish-operations
  2. Doug Camposano, Alexander Mills and Catherine Piton, “A single-use, clinical-scale filling system: from design to delivery.” BioProcess International, June 15, 2016. http://www.bioprocessintl.com/manufacturing/single-use/a-single-use-clinical-scale-filling-system-from-design-to-delivery/
  3. Mobius®, http://www.merckmillipore.com/GB/en/mobius-single-use-manufacturing/mobius-formulation-and-fill/mobius-fill-finish/9RCb.qB.BeMAAAFDX8JZXvQV,nav?bd=1
  4. Lorna D. McLeod, S Anne Montgomery and Cheryl Scott, “Fill and finish for biologics.” BioProcess International, June 1, 2011. http://www.bioprocessintl.com/manufacturing/fill-finish/fill-and-finish-for-biologics-316516/

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