Friday, January 17, 2014

BioProcess International: Inactivated Poliovirus Vaccine Made in Modular Facilities with Single-Use Technology

Our excerpt today has been provided by Adriana G Lopes, Managing Director, LLB Global Health Solutions Ltd. in London, UK, Andrew Sinclair, Managing Director, Biopharm Services, and Nigel Titchener-Hooker, Director, Advanced Centre of Biochemical Engineering, Department of Biochemical Engineering at University College London. 

If current efforts to eradicate polioviruses worldwide are successful, then the oral poliovirus vaccine (OPV) currently used for routine immunization in low- and middle-income countries (LMICs) will be replaced by inactivated poliovirus vaccine (IPV). IPV will become the only option for such countries if they want to continue to vaccinate against polio (1). Because IPV is currently considered to be too expensive for use in LMICs, strategies are being undertaken to make IPV more affordable (2). Some experts estimate that in 5–10 years there will be a lack of IPV manufacturing capacity worldwide (3). That will most affect LMICs, which depend on external vaccine supplies. So expansion of existing facilities (or building new ones) will be key to meet future demand. Here we examine the use of alternative technologies such as modular manufacturing facilities and single-use equipment as means to improve IPV affordability and capacity.

Figure 1: 

Main Drivers for Implementation of Modular Facilities and Disposables in Vaccine Production: One major argument for modular facilities is their time savings over a conventional construction approach (4). Even though the initial cost for using modular facilities exceeds that of conventional methods, an assurance of predictable outcome and time savings provides earlier return on investment for clear cost savings. Time is saved by conducting activities in parallel, which allows for significant compression of tasks (Figure 1). With all construction undertaken in a controlled environment, results are consistent and quality is enhanced. Equipment installed within each module (at its final operating location) will require no reassembly or extensive retesting. The building and fit-out of modules to good manufacturing practice (GMP) specifications in an external environment provides further benefit when applied to LMICs because technical skills required to complete and validate a facility to suitable specifications would not be required within the country itself.

Single-use technologies typically allow for a simpler facility design than their stainless-steel counterparts because complex clean-in-place (CIP) and steam-in-place (SIP) systems are no longer required to support the equipment between operations. So disposables facilitate faster design, construction, and commissioning of facilities as well as offering manufacturing flexibility through the reconfiguration of manufacturing suites. A smaller, less complicated facility can be built, commissioned, qualified, and validated in 12–18 months rather than four years (5).
The scale of viral vaccine production is generally smaller than that of many other processes (ranging 500–2,000 L), so known limitations of scale involved with single-use technologies (max 2,000 L) can be advantageous for this application. Compared with traditional approaches, single-use technology offers many benefits for vaccine manufacturing (6, 7):
  • Fast turnover maximizes facility output (no CIP or SIP operations).
  • Reduction of capital investments is linked to reduction and simplification of facility design and to lowered equipment investment.
  • Viral production must be handled in a biosafety containment level 3 environment. Single-use technology simplifies production areas because of smaller equipment footprints, lower ceiling heights, and elimination of water-for-injection and steam utilities.
Our aim is to evaluate the potential of using these alternative technologies — modular facilities and single-use technology — for affordable and sustainable IPV production in LMICs.

View the full article here. BPI will be joining us February 24-25 for the 2nd Annual Flexible Facilities Conference in Berkley, Ca. To learn more, view our agenda.

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