Lack of CMO availability threatens cell and gene therapy development

27th March 2018 (Last Updated March 27th, 2018 15:33)

With a lack of contract manufacturing organizations (CMOs) operating in the cell and gene therapies sphere, it appears to be heading towards major capacity crunches in both R&D and commercial manufacturing.

Cell and gene therapies are relatively new classes of treatment for commercial biopharmaceutical development. Although these treatment types are not currently standards of care, they both offer potentially significant therapeutic value to the treatment landscape.

However, with a lack of contract manufacturing organizations (CMOs) operating in the cell and gene therapies sphere, it appears to be heading towards major capacity crunches in both R&D and commercial manufacturing.

Although many of the larger pharma companies are financially able to construct or acquire facilities to enable the manufacture of these classes of treatments, many of the mid-size to smaller companies involved will be significantly reliant on the services of CMOs to market and manufacture cell and gene therapies. The waiting times now average more than 15 months for CMOs to start cell and gene therapy projects, and this will only increase unless more CMOs with technical competence enter the field.

Recently, Lonza has been focusing a great deal of attention on increasing its cell and gene therapy capacity. The company is planning to establish Centers of Excellence for cell and gene therapy at its Pearland, Texas, US and Geleen and Maastricht, Netherlands facilities. Last year, Lonza announced construction of the new Pearland site, which should shortly be functional. This site’s capabilities will more than double the company’s production capacity for viral gene and virally modified cell therapies. Many of the larger CMOs are likely to follow suit over the course of the next five to 10 years; however, hiring sufficiently qualified staff and the investment required to gain related capabilities will prove a strong barrier for many in the industry.

Related reports

Bio/Pharmaceutical Outsourcing Report (B/POR) (2018) ‘Lonza Turns Attention to Cell and Gene Therapy in the Wake of 2017 Growth’, PharmSource, 23(3).