Project Farma: Manufacturing Skills Gap Creates Bottleneck for Cell and Gene Therapy

Cell and Gene Therapy

The skills gap in cell and gene therapy is creating a bottleneck that is slowing the abilities of innovative therapies to reach patients, delaying manufacturing scaleup and increasing learning and development costs.

“The shortage runs across every functional team, at every level,” Anshul Mangal, president, Project Farma & Precision ADVANCE, told BioSpace.

What’s different about cell and gene therapy – versus biologics, for example – is the newness of the field.

“Cell and gene therapy is very personalized…very innovative,” he said.

There’s great expertise in R&D, but few cell and gene therapies have reached commercial scale. Therefore, cell and gene therapies have fewer experienced personnel available with experience in scaling-up.

“One of the largest gaps is in manufacturing,” Mangal said. “Advanced therapies really started to become industrialized in the past five years and talent in the manufacturing and technical operations spaces are in high demand. There’s not enough of people (with the right skills to fill the needs).”

For example, research from the U.K.’s Cell and Gene Therapy Catapult (CGTC) noted that the U.K.’s workforce in this space needed to double from 3,000 in 2019 to 6,000 by 2024. Comparable data for the U.S. is lacking.

The U.S. leads the cell and gene therapy space, Mangal pointed out, so the need for manufacturing expertise here is great.

“There are more than 1,000 cell and gene therapy developers and the world, and more than half of them are in the U.S.,” he said. “Also, of the more than 1,2000 advanced therapy clinical trials globally, most are in the U.S. Close to $20 billion was invested in cell and gene therapy last year.”

In fact, 2020 was a record-shattering year for regenerative medicine.

“As of February 2020, however, the FDA has approved only nine cell and gene therapies treating cancer, eye diseases and rare hereditary diseases,” he said. “As these projects move towards commercial launches, manufacturing needs will be great.”

The field is on the cusp of potentially explosive growth.

Currently, manufacturing professionals are being recruited from biologics and other disciplines, as companies hire “people who leverage their previous experience and apply it to cell and gene therapy,” Mangal said. But it takes hundreds, if not thousands, of talented people to take each cell or gene therapy from clinical trials to commercial launch.

Recently, the industry started to think seriously about building workforce skills for advanced therapies.

In the U.K., the CGTC launched the Advanced Therapies Skills Training Network to offer online training, national training centers and a career converter tool.

The career converter helps users measure their skills against those needed in the advanced therapies and vaccine manufacturing areas. Many skills are transferrable, the CGTC pointed out, including project management, digital expertise and business and technical acumen.

As part of the CGTC initiative, Rentschler Biopharma, a German contract development and manufacturing organization (CDMO), just announced plans to locate a Center of Excellence for cell and gene therapy alongside Catapult’s site in the U.K. It plans develop a state-of-the-art manufacturing site for viral vectors for clinical supply, and to begin cGMP manufacturing by the first half of 2022.

The CGTC also is working with the British government and Innovate U.K. to coordinate training courses and increase the number of training centers throughout the country. In 2018, it created apprenticeships with 37 companies to bring workers into the industry. So far, 137 apprentices have signed up – 2.7 times more than anticipated.

The need for advanced cell and gene therapy expertise has been noticed in the U.S., too.

“Universities are creating more majors and programs that are related – like undergraduate and graduate majors in biotechnology and biomanufacturing – as well as research and manufacturing centers that offer hands-on training and development,” Mangal said. “They’re also offering courses and certificate programs in cell and gene therapies,” for those already working in the industry.

For example, NC State University has a Biomanufacturing Training and Education Center that provides educational and training opportunities for the biomanufacturing industry.

“The U.S. has fantastic engineering schools for biology, chemical and biomedical engineering, but cell and gene therapy is an area that needs more attention,” he added.

American states also are getting behind this push.

“Most states have local incentives to spur innovation and training, but more can be done,” he said.

State and federal grants, for example, aren’t just for research and development. Grants also are available to help develop workforce skillsets.

The COVID-19 pandemic caught the world’s vaccine developers and manufacturers flat-footed. Until this past year, there has been little incentive to manufacture vaccines in the U.S. and, some would say there were disincentives.

“People are very educated about vaccine development, but we need more people skilled in vaccine manufacturing,” Mangal emphasized. The SARS-CoV-2 virus “opened our eyes to future viruses that may affect the population, so additional help is needed. We need more capacity to produce vaccines almost on demand, and certainly to produce them more efficiently.”

To help companies directly, Project Farma created an Advanced Therapy Manufacturing Playbook.

“It includes all our experience and expertise for cell and gene therapies,” Mangal said.

This playbook includes a streamlined roadmap that leads clients from early clinical stage manufacturing, even pre-clinical, to commercialization.

“This playbook has been critical as a starting point to train and educate the cell and gene therapy community and to achieve operational excellence and accelerate speed to market for next-generation medicines.  It’s our obligation as a member of the life science community to share our experience and knowledge to help bring these life changing medicines to the patients in need,” he said. “The playbook is a collection of information rather than a specific link and we are always seeking ways to share this information with the community via speaking engagements, presentations and white papers,” he noted.

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