The accelerated pathway through the clinic of viral vector-based cell and gene therapies puts pressure on developers to find a skilled partner that can consistently manufacture high-quality product. Production of viral vectors requires specialized requirements including experience in cell-based production and vector purification, mature quality management systems, and a track record of regulatory compliance.

Most techniques used in viral vector manufacturing were originally established for antibody production; however, there are unique considerations for viral vectors that present a challenge. Traditionally, adherent culture, where cells are cultured by attaching to a modified plastic surface, has been the established method for viral vector production. As a result, scale is limited by the surface area of the culture vessel. Scale-out techniques rely on manual manipulation of numerous culture vessels in an open biosafety cabinet. This approach limits production scale and introduces risk to the manufacturing process.

Alternatively, facilities designed and experienced in suspension culture using single-use bioreactors achieve larger scale-up volumes, increased output, lower costs, and robust risk mitigation. However, this strategy of scale-up requires specialized expertise and facility design.

Enabling Successful Production

By developing a process with scale-up capabilities early on, both clinical and commercial needs can be addressed. Having a robust process early minimizes unnecessary process changes and the comparability studies required to demonstrate equivalence.
Facility design also contributes greatly to efficiency and quality. Production facilities should streamline the flow of people, products, materials, waste, and equipment using unidirectional flow.  Easily configurable, single-use solutions and innovative cleanroom design afford flexibility and efficiency, allowing production teams to optimize facility capacity and better meet production timelines. Coupled with a closed process, robust gowning program, single-pass air handlers, and unidirectional cleanroom flow, manufacturers ensure their people and products are safe and compliant.

In addition, a strong quality culture can save money and reduce time to market. Thorough vetting of supply chain partners mitigates risk and controls the security of supply. Strict compliance to standard operating procedures and thorough training are also standard within robust quality organizations.

MilliporeSigma Will Navigate Your Journey

Viral vector production requires specialized expertise in process design and regulatory compliance, along with a fit-for-purpose facility managed by an experienced team committed to quality manufacturing. A CDMO partner can be the quickest, most efficient way to achieve these goals. CDMOs provide complex bioprocessing expertise, technical personnel, cGMP environments, and scale-up.

MilliporeSigma’s commercial experience in viral vector manufacturing, combined with our newly launched large-scale facility equips us with the expertise and capacity to help you achieve commercial success even faster.

We’ll develop your process design, and our experts will guide you through the upstream and downstream production challenges – all while managing your regulatory compliance. With continued process verification, we’ll assure consistent quality product, critical process parameters, and a rigorous change management process.

For over 25 years we’ve charted numerous viral vector programs from clinical to commercial. Embark with us on your voyage to commercialization.

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