MilliporeSigma’s New Platform Speeds Development of Cell & Gene Therapies

MilliporeSigma has recently bolstered its viral vector manufacturing capabilities with the launch of its VirusExpress Lentiviral Production Platform. This new platform helps to overcome lentiviral production challenges and can reduce process development time by approximately 40%, based on MilliporeSigma’s experience as a contract development and manufacturing organization.

“Cell and gene therapies offer the potential for curative treatments and are being developed and commercialized in half the time it has taken traditional therapies,” said Angela Myers, Head of Gene Editing & Novel Modalities at MilliporeSigma. “We are committed to accelerating manufacturing of cell and gene therapies with the ultimate goal of getting these lifesaving treatments to patients faster. By increasing dose yields and dramatically reducing process development time, this new platform will help us reach this goal.”

Using a suspension cell line rather than an adherent-based production, coupled with a chemically defined cell culture media and process with built-in scalability, MilliporeSigma’s VirusExpress Platform meets multiple market needs. In addition to accelerating process development, the suspension culture format allows each batch of virus to be larger yielding more patient doses. Additionally, suspension culture is amenable to true scale-up, while being less labor-intensive. The chemically defined medium eliminates the safety, regulatory, and supply chain concerns related to animal- and human-derived materials.

MilliporeSigma’s VirusExpress Platform offers a simplified upstream workflow, making processes easier to manage, adjust and scale. Flexible licensing allows companies to manufacture vectors by using either MilliporeSigma’s contract manufacturing capabilities, a third-party contract development and manufacturing organization, or in-house development.

MilliporeSigma is a leading contract development and manufacturing organization combining an integrated portfolio of manufacturing solutions with proven commercialization experience. This new offering underscores MilliporeSigma’s continued investment in cell and gene therapies. In April 2020, the company announced a new $110-million, 140,000-square-foot manufacturing center at its Carlsbad, CA, location that will double the existing production capacity and support large-scale commercial manufacturing. Today, MilliporeSigma manufactures vectors for two of the first five FDA-approved cell and gene therapies.

The cell and gene therapy market is growing rapidly and continues to show great promise. According to market research leader Arizton, the cell and gene therapy market is expected to reach more than $6.6 billion by 2024. MilliporeSigma has been involved in this space since clinical trials for gene therapy began in the 1990s.