Meeting CGT Demand

The number of cell and gene therapies (CGT) that are commercially available has seen stable growth in recent years. As technological advances continue to allow scientific breakthroughs and development pipelines in CGT become more saturated, Europe must start to tackle some of the manufacturing and talent gaps that could impede the market in the future.

In a recent McKinsey insights article, the authors noted that the unmet need for CGTs in Europe exceeds that of the United States and the region’s regulatory authorities are keen to support new therapies that target underserved disease areas, but the CGT industry in Europe is faced with specific challenges (1). Funding, a more risk-averse ethos, payer costs, and a fragmented market are all specified as unique challenges to the European market, in addition to a lack of manufacturing capacity and expertise (1).

Recent investment

However, the dawning of 2021 has seen a flurry of investment happening in the European CGT space. In January 2021, Polyplus-transfection unveiled plans for a new facility in France that will provide additional manufacturing capacity for ex-vivo and in-vivo therapy products. Construction of the facility is already underway, and it is expected to be operational in the third quarter of 2021 (2).

Rentschler Biopharma is also boosting the CGT ecosystem in Europe, with the establishment of manufacturing capability for advanced therapy medicinal products (ATMPs) at the CGT Catapult site in Stevenage, UK (3). “This [investment] will build new capacity to benefit the international ATMP supply chain and meet growing academic and commercial demand across the industry,” said Matthew Durdy, CEO of the CGT Catapult, in a press release (3).

In Spain, gene transfer technologies contract development and manufacturing organization (CDMO), VIVEbiotech, is expanding its lentiviral-vector manufacturing capabilities with new facilities (4). “The continued expansion of the gene and cell therapy sector has resulted in an increase in the number of clinical trials, as well as additional trials moving into later-stage development. In turn, this has led to a continued increase in the demand for both lentiviral vectors, as well as expertise in their use and application,” said Gurutz Linazasoro, CEO of VIVEbiotech, in a press release (4). “This demand for lentivirals is increasing for therapies throughout the clinical stages and into commercialization.”

The skills gap

Increasing manufacturing capacity for CGTs and advanced therapies is of limited use if there is insufficient talent with the skills necessary to actually manufacture the innovative treatments at scale. In the United Kingdom alone, CGT companies, who participated in a 2019 survey, specified that manufacturing posed the greatest concern in terms of skills gap for the future and could delay future company expansions (5).

These skills shortages concerns are by no means limited to the UK either; they are being raised as global issues that must be addressed immediately. According to Ronald Rader, there may even be a worsening of staff shortages due to the retirement of the ‘baby boomer’ generation and the acceleration of CGT development pipelines from research to clinical and commercial production (6).

There are already some initiatives underway, such as the bespoke course launched by CGT Catapult in partnership with the University of Hertfordshire on aseptic manufacturing of CGTs in line with European regulatory guidance (7), but much more work in this area is needed to ensure demand for talent can be met and industry growth across the region is not hindered.

References

1. A. Loche, et al., “A Call to Action: Opportunities and Challenges for CGTs in Europe,” McKinsey & Company, Article, 19 Jan. 2021.
2. Polyplus-transfection, “Polyplus-transfection Initiates Construction of Vectura, a New 4000 m² Facility,” Press Release, 27 Jan. 2021.
3. Rentschler Biopharma, “Rentschler Biopharma Entry into Cell and Gene Therapy,” Press Release, 10 Feb. 2021.
4. VIVEbiotech, “VIVEbiotech Expands Facilities to Increase Innovation and Manufacturing Capabilities of Specialist Lentiviral Vectors,” Press Release, 24 Feb. 2021.
5. CGT Catapult, UK Cell and Gene Therapy Skills Demand Report 2019 (27 Nov. 2019).
6. R. Rader, Pharm. Tech., 44 (10) 56–59 2020.
7. CGT Catapult, “Supporting Progress of Cell and Gene Therapy Industrialization with New Aseptic Manufacturing Course,” Press Release, 20 Jan. 2020.

About the Author

Felicity Thomas is the European editor for Pharmaceutical Technology Group.

Article Details

Pharmaceutical Technology Europe
Vol. 33, No. 3
March 2021
Page: 6

Citation

When referring to this article, please cite it as F. Thomas, “Meeting CGT Demand,” Pharmaceutical Technology Europe 33 (3) 2020.