- Viralgen has partnered with Elaaj Bio to support development and manufacturing of the investigational gene therapy ELJ-101 for CDKL5 Deficiency Disorder.
- The collaboration includes AAV process development, scale-up manufacturing, and analytical support ahead of a planned clinical trial in early 2027.
Viralgen has entered into a partnership with Elaaj Bio to support the development and manufacturing of ELJ-101, an investigational gene therapy for CDKL5 Deficiency Disorder (CDD). Elaaj Bio is a wholly owned subsidiary of the Loulou Foundation, a nonprofit organization focused on therapies for CDD.
Under the agreement, Viralgen will provide contract development and manufacturing organization (CDMO) services related to recombinant adeno-associated virus (rAAV) vector production. The scope of work includes process development and optimization, manufacturing at multiple scales, analytical characterization, and quality control activities.
The companies stated that initial development work has already been completed, demonstrating the technical feasibility of the manufacturing approach. Current activities are focused on process scale-up and preparation of larger-scale batches to support future clinical development.
“By working with Elaaj Bio and the Loulou Foundation, we’re uniting complementary strengths in development and manufacturing to help accelerate ELJ-101 toward clinical development.”
Jimmy Vanhove, Chief Executive Officer at Viralgen
CDKL5 Deficiency Disorder is a rare developmental and epileptic encephalopathy caused by alterations in the CDKL5 gene. The partners plan to initiate the first clinical trial for ELJ-101 in early 2027, with manufacturing scale-up activities currently underway to support the program.
