Introduction

Antibody-based products face three primary demands as they scale from R&D to commercial manufacturing – protect quality, minimize expenses, and simplify scale-up. Since bioreactor production technology factors heavily into addressing these demands, it is critical that each organization thoroughly explores all available manufacturing options. To that end, Biovest has launched mAbVault.

mAbVault

mAbVault is a network of Contract Research Organizations (CROs) and Contract Manufacturing Organizations (CMOs) with expertise in hollow fiber bioreactors (HFBR). HFBR is a technology platform that has quietly become known for consistency in yields and quality, minimized start-up costs and seamless scale-up. Learn more about HFBR in this recent Cell Culture Dish article “Hollow Fiber Provides a Sweet Spot for Several Biomanufacturing Applications”.

Challenges with Standard CMO Operations

Technologies employed by most CMOs can be variable in the yield reached and time to reach it. Due to this variability it can be difficult to predict scale-up and protein production costs with accuracy, thus requiring pricing to be based upon time and materials. This type of arrangement leaves the protein owner with an unclear picture of the cost and timeline for their protein production and subsequently they shoulder the majority of the risk.

When it is time for scale-up of the process, another level of risk is introduced as a new manufacturing process and equipment is often required. The implementation of new technology requires costly re-validation time periods and potential issues with product quality changes. In addition, utilizing a single CMO supplier does not fully address redundancy needs and thus protect against unpredictable product shortages.

How mAbVault is Different

mAbVault offers a fixed price for the life of the product, through all regulatory stages, guaranteed. This approach eliminates up-front protein development and technology transfer expenses. Protein owners pay only for delivered product, thus reducing overall production expenses by up to 60% versus ascites, rocking bioreactors and tanks.

mAbVault makes scaling up easy. Production is validated to a single hollow fiber bioreactor cartridge that provides consistent quality and yields. Scaling up consists of adding incremental cartridges in lateral production, with no need to re-validate as you move from mg to kg quantities.

Additional advantages of mAbVault

• Inventory expenses are kept off the books through just-in-time delivery
• mAbVault vetted CMOs are GMP-compliant facilities that employ experts in hollow fiber technology
• Second site production and storage is standard
• Over 1700 organizations served globally and 2700 cell lines expanded – through all stages of regulatory compliance

Take advantage of robust supply chain systems already serving top global therapeutic and diagnostic organizations, please contact the authors with questions or to learn more.