Vaccine and gene therapy focused CDMO secures GMP certification for Belgian site

CEO of Exothera, Thibault Jonckheere, said the accreditation from Belgium’s Federal Agency for Medicines and Health Products (FAMHP), which followed a series of inspections, will enable it support new customers whose products are in early development stage but will also allow all of its existing partners to meet their large-scale manufacturing needs.

Exothera, a Univercells spin-out, began operations in 2020 with the stated goal of helping to alleviate some of the most critical challenges manufacturers face in bringing advanced therapies to market: a lack of production capacity and scarcity of bioprocessing expertise. “Specific viral vector bioprocessing expertise is key to addressing the more complex manufacturing processes required for cell and gene therapy manufacture. These challenges have been keeping costs unnecessarily high and slowing the development and delivery of ground-breaking therapies from reaching those who need them most.”  ​

Initial operations began at two sites located in Nivelles and Gosselies while renovation and construction of new offices and large process development and production areas took place in two buildings on the Univercells campus in Jumet. These facilities provide a combined area of 8,600 m² (92,570 ft²), reported the company.

Adherence and suspension platforms

It has now “one of Europe's largest state-of-the-art facilities”​ with a GMP qualified manufacturing area totaling 2,100 m² (22,600 ft²).  That site, it continued, includes upstream grade C cleanrooms with several bioreactor technologies for adherent and suspension cell culture. The bioreactors can go up to 2 x 2,000L for the suspension platform and 2 x 600m² (2 x 6,450 ft²) for the adherence platform, designed for customer flexibility.

In July last year, Pall inked a $7m deal​​ with Exothera for the provision of a full end-to-end solution including stirred tank bioreactors and filtration and chromatography equipment and all the mixers and totes required to manufacture viral vectors at large scale.

To date, the Belgian CDMO has worked on more than 28 projects for clients in the EU and US and reports that it has the space available to develop a further 9,000 m² (96,900 ft²) on the Jumet campus plus other greenfield options, with it also weighing up options to grow internationally “depending on client needs”.​

The addition of more manufacturing capacity is an important step to alleviate some of the current constraints in the industry. The pressure to develop and manufacture billions of vaccines, together with an expected 30+ new drug approvals by the US Food and Drug Administration (FDA) in the next year will put immense pressure on the global manufacturing capacity, it stressed.