Nohla signs WuXi AppTec to make cell therapies for bone marrow function
Under the commercial agreement, contract development and manufacturing organisation (CDMO) WuXi AppTec will use cell culture and expansion capabilities to make NLA101 at its 55,000 sq. ft. facility in Philadelphia Navy Yard, Pennsylvania.
The facility is dedicated to allogeneic and autologous cell-based therapeutics commercial manufacturing.
NLA101 as a universal donor, off-the-shelf, ex vivo expanded hematopoietic stem and progenitor cell product, designed to provide the support of bone marrow in patients with hematologic disorders and other critical diseases.
“The product consists of rapidly repopulating hematopoietic stem/progenitor cells (HSPCs) manufactured by culture of cord blood derived CD34+ cells on a proprietary platform with an engineered Notch ligand, Delta1,” Nohla spokesperson DeNike explained.
According to the firm, it provides rapid, transient haematopoiesis with long-term benefits.
“NLA101 was intentionally developed to be a short-term therapy that provides temporary bone marrow function that persists two to three weeks, until a patient’s immune system recovers while inducing long-term immunologic benefits with the potentially for improved survival.”
The cell therapy is manufactured ahead of time, and frozen – cryopreserved – for immediate use.
“NLA101 is differentiated from other autologous or patient-specific allogeneic cell therapies as it does not require tissue matching,” DeNike told us.
This is the first time Nohla has partnered with WuXi.
“We are excited to partner with WuXi AppTec Advanced Therapies to gain their expertise and current good manufacturing practice (cGMP) manufacturing capabilities to support the ongoing development and anticipated global commercial demand for our lead cell therapy programme,” said DeNike.