Andelyn Biosciences & Purespring Therapeutics Partner to Manufacture Novel Gene Therapies for Kidney Diseases

Andelyn Biosciences, Inc. has recently partnered with Purespring Therapeutics to accelerate the manufacture of their gene therapies for the treatment of chronic renal diseases that are currently poorly addressed. The partnership will enable Purespring to advance and accelerate clinical development of its portfolio of gene therapy programs targeting chronic kidney diseases.

Purespring is challenging the status quo by developing therapies that have the potential to stop or significantly slow down chronic kidney diseases. Through this partnership, Purespring will leverage Andelyn’s experience in adeno-associated virus (AAV) production and adapt Andelyn’s suspension platform to manufacture its innovative pre-clinical and clinical gene therapy products under GMP. The partnership will serve to maximize program efficiencies and accelerate timelines to the clinic.

The partnership between Purespring and Andelyn further strengthens their longstanding working relationship and offers great hope for patients suffering with chronic kidney diseases. Both organizations are aligned in their commitment to gene therapies and share the belief that these novel treatments will contribute meaningfully to the advancement of human health.

Matt Niloff, Chief Commercial Officer of Andelyn, said “Andelyn’s configurable AAV suspension platform is based on our vast database of historical data and decades of experience in viral vector development and quality manufacturing. We are honored to partner and serve as a key contributor to progress Purespring’s all-important kidney programs.”

Julian Hanak, CEO of Purespring, added “Robust, high-quality manufacturing is absolutely critical to gene therapy. Purespring is excited to build on our longstanding working relationship with Andelyn to accelerate the pre-clinical and clinical manufacture of our innovative AAV-based gene therapies to help meet the unmet medical need of kidney disease patients worldwide.”

With continuation of its GMP manufacturing capabilities now at the new 185,000-sq-ft Andelyn Corporate Center, Andelyn is proud to offer its clients exceptional quality and large-scale suspension clinical and commercial manufacturing in the now well-established Columbus, OH, biotech hub. Andelyn also offers preclinical process development and plasmid manufacturing at its other two Columbus facilities.

Andelyn Biosciences is a full-service cell and gene therapy CDMO focused on the development, characterization and production of viral vectors for gene therapy. With more than 20 years of experience, Andelyn’s deep scientific expertise has resulted in the production of cGMP material for more than 450 clinical batches and 75 global clinical trials. Operating out of three Columbus, OH, facilities, Andelyn supports its clients in developing curative cell and gene therapies from concept through plasmid development and manufacturing, process development, and cGMP clinical and commercial manufacturing. Andelyn’s versatile capabilities include cGMP manufacturing capacity for both adherent and suspension processes up to a 2,000-liter capacity. An advanced digital model, quality system, full regulatory support and supply chain vertical integration help Andelyn accelerate the development and manufacturing of its clients’ innovative cell and gene therapies. For more information, visit andelynbio.com.