KBI Biopharma, Inc. (KBI), a JSR Life Sciences company and global cGMP contract development and manufacturing organization (CDMO), has signed a manufacturing contract with Alanis Therapeutics, Inc. (ATI) for the development of an innovative pre-clinical therapeutic antibody to treat myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML) blood cancers.

As part of this collaborative agreement, KBI will oversee cell line development, process optimization, analytical and formulation development, and the manufacturing of Alanis’ pre-clinical antagonistic antibody (mAb).

Utilizing KBI’s advanced monoclonal antibody development and manufacturing platform, SUREmAb™, KBI will begin the production of ATI’s lead antibody, focusing on streamlining, accelerating, and optimizing the mAb production process for clinical testing.

“We are pleased to select KBI as our trusted CDMO to advance our lead antibody to the Notch pathway. By collaborating with KBI, we aim to accelerate the development process and move closer to evaluating the full therapeutic potential of our antibody in clinical trials. This is a step forward in our mission to improve outcomes for patients affected by these challenging diseases,” said Dr. Robert Goodenow, CEO of Alanis Therapeutics.

“We are proud to support Alanis and spearhead the development of its lead target. Our advanced platforms are optimized to streamline manufacturing, and with our SUREmAb™ technology at the forefront, our integrated workflow, high productivity levels, and streamlined process provide a fast path from cell line transfection to the final stages of cGMP drug substance manufacturing. This enables Alanis to expedite their mAb toward investigational new drug submission (IND) and bring it one step closer to patients, underscoring KBI’s commitment to advancing innovative therapies,” said Tim Lowery, CEO of KBI Biopharma and President of JSR Life Sciences.

KBI Biopharma, Inc., a JSR Life Sciences company, and its affiliates is a global contract development and manufacturing organization (CDMO) providing fully integrated, accelerated drug development and biologics manufacturing services and expertise to life science companies.

As a global leader in mammalian cell line development, with best-in-class modular technology and highly specialized solutions, KBI enables the life sciences industry to rapidly discover, develop, and commercialize innovative medicines and vaccines. With each of its 500+ customer partners, KBI works closely to personalize and rapidly accelerate drug development programs.