- Surrozen is developing first-in-class bi-specific antibodies that selectively stimulate tissue regeneration
- Lonza to provide cell line development, drug substance and drug product process development and cGMP manufacturing, and regulatory support for IND filing
- Lonza's Light Path™ cell line development program will be tailored enabling Surrozen to prepare for their IND filing
Quote from Karen Fallen, President, Head of MMDM, Lonza:
“Lonza's subject matter experts enjoyed working with the Surrozen's technical team to identify specific molecule needs to design a tailored Light PathTM cell line development work package suitable to achieve their goals. This produced two critical outcomes; an end to end program beginning with their gene, ending with drug product and a CMC IND readiness package that will support Surrozen on their first IND filing. An enhanced, strong and collaborative working relationship between the parties drastically improves the chance of project success. ”
Quote from Craig Parker, president and chief executive office at Surrozen:
“We are excited to be working with Lonza, which has industry leading capabilities and expertise with complex biologics including antibodies and bi-specific molecules. Lonza's extensive biologics development, manufacturing and CMC regulatory experience makes them an ideal partner for novel molecules like our SWAP and SWEETS bi-specific antibodies. Based on our molecules and some unique program needs, Lonza took a flexible and adaptable approach to designing a program that was tailored to meet our specific needs.”
San Francisco (CA), USA and Basel, Switzerland, 29 May 2020 – Surrozen Inc., a biotechnology company pioneering a new class of targeted regenerative antibodies, and Lonza today announced that the companies have signed a collaboration agreement. Lonza will provide contract development and cGMP manufacturing services for Surrozen's first two, and potentially additional, development candidates.
Surrozen will leverage Lonza's process development and manufacturing capabilities and expertise in cell line development, early-stage formulation development and drug product manufacture. Process development and drug substance manufacturing will take place in Lonza's cGMP facility for mammalian biopharmaceuticals in Slough, UK. The early-stage formulation and DP manufacture will be carried out in the Drug Product Services facility in Basel and Lonza's recently acquired fill and finish facility in Stein, Switzerland.
The agreement includes Lonza's Light Path™ cell line development program that will provide Surrozen with material to enter a phase I clinical study. This offering that includes gene to cGMP drug substance and drug product production services will help Surrozen to meet their clinical product supply needs as well as provide a CMC regulatory package for their IND filing. The scope of the package was tailored for the molecule to ensure the program met their requirements.
The two initial development candidates represent potent multivalent bi-specific antibodies that directly activate the Wnt signaling pathway, which regulates multiple biological processes and plays a key role in tissue homeostasis and injury repair. These candidates are both in the preclinical phase with potential INDs in 2021 and 2022. Surrozen's targeted approach to tissue-specific regenerative medicine aims to impact many areas, including neurodegenerative, lung, and inflammatory diseases.