Lonza Pharma & Biotech and Denali Therapeutics have formed a partnership on Denali’s biologic pipeline products for neurodegenerative diseases. The agreement covers all stages of the development and manufacturing.

A major hurdle for treating neurodegenerative diseases is the inability of most biologics to cross the tightly controlled blood-brain barrier (BBB). Denali is engineering its biologic product candidates to overcome this fundamental obstacle. Manufacturing these sophisticated therapies requires a tailor-made approach, together with expertise and agility in cell line, process and formulation development.

Through this partnership Denali will have access to Lonza’s expertise and technologies-from cell-line development using the GS Xceed gene expression system to process development and manufacturing at facilities in Slough, UK and Hayward, CA. In addition, Lonza’s in-house drug product services in Basel, Switzerland will focus on ensuring that Denali’s finished product candidates are designed with optimal formulation, stability and delivery system in mind.

“We’re taking up the challenge with Denali and helping them bring potential therapies to patients suffering from these debilitating diseases,” said Marc Funk, chief operating officer, Lonza Pharma & Biotech. “This partnership will allow us to do what we do best for our customers-leverage our expertise across the development cycle and anticipate Denali’s needs as they move from pre-clinical to clinical and beyond.”

Denali’s chief executive officer, Ryan Watts, said, “We are thrilled to work with Lonza to develop our biologic candidates for patients suffering from neurodegenerative diseases. Lonza’s expertise and experience in manufacturing biologics is hugely helpful to Denali in developing our pipeline.”