Catalent and Elpida Therapeutics Join Forces for Gene Therapy Scale-Up
Catalent partners with non-profit Elpida Therapeutics to support late-phase AAV manufacturing for a rare neurological gene therapy, securing exclusive rights across Elpida's broader AAV pipeline.
Elpida Therapeutics, a non-profit biotechnology company developing gene therapies for ultra-rare diseases, and Catalent, a global CDMO, announced a strategic partnership to support late-phase manufacturing of Elpida’s lead program, an AAV9 gene therapy for Spastic Paraplegia Type 50 (SPG50). Under the agreement, Catalent will also be granted exclusive manufacturing rights to Elpida’s other pipeline adeno-associated virus (AAV) gene therapy programs.
SPG50 is an ultra-rare neurodegenerative disorder caused by AP4M1 mutations, beginning in infancy. Untreated, the disorder leads to cognitive impairment, epilepsy and progressive paralysis by early adulthood.
“This partnership reflects Catalent’s commitment to applying our broad gene therapy manufacturing expertise and Patient First approach to programs with significant unmet need,” said David McErlane, Biologics Group President for Catalent. “By leveraging our broad expertise in end-to-end AAV capabilities, we look forward to supporting Elpida’s SPG50 program through late-phase manufacturing so it can advance toward regulatory submission.”
Catalent will utilize its industry-leading UpTempoTM AAV manufacturing platform, incorporating its proprietary HEK293 cell line, pre-validated off-the-shelf AAV plasmids, and pre-qualified analytical assays, to accelerate the production of R&D and GMP-grade material required for SPG50 process validation and to assist Elpida with its Biologics License Application submission. Catalent has partnered with clients on over 80 gene therapy programs, including four commercial programs to date, from early development through all clinical stages and commercialization.
