ABOUT ANDELYN BIOSCIENCES
Andelyn Biosciences is a pioneering gene therapy organization born out of Nationwide Children's Hospital, where the first FDA-approved systemic gene therapy was discovered.
With more than 15 years of experience in AAV vector manufacturing, Andelyn is a full-spectrum CDMO. We bring scalability, capacity, efficiency and expert resources to manufacturing matrices, all to advance the development of viral vector-based therapeutics.
As a global provider of gene therapy solutions, Andelyn has been a trusted partner in over 60 US, EU and ROW clinical trials.
Discover more about our capabilities at AndelynBio.com.
Take a look behind the scenes and hear firsthand about the commitment to patients and clients at Andelyn Biosciences in this video.
A Unique Business Model Benefitting Pediatric Research Through Geriatric Research
As an affiliate organization of Nationwide Children’s Hospital, Andelyn Biosciences’ unique business model allows for reinvestment into pioneering gene therapy research conducted at the world-class Abigail Wexner Research Institute to uncover the next generation of cures for rare diseases.
This forward-thinking business model allows us – and you – to support the future of gene-based research.
Discover more about the Abigail Wexner Research Institute here: https://www.nationwidechildrens.org/research
575 Children's Crossroad
Columbus, OH 43215
Leveraging more than 15 years in the field, Andelyn Biosciences provides custom development and manufacturing of AAV vectors for gene therapy as a full-service concept-to-commercialization cGMP CDMO.
The road to the formation of Andelyn Biosciences started more than 15 years ago on the third floor of a research building at Nationwide Children’s Hospital in Columbus, Ohio. At that time, GMP facilities were unheard of at children’s hospitals and gene therapy research was a rarity.
Looking for scalability in clinical manufacturing? Andelyn Biosciences' current Good Manufacturing Practices (cGMP) Clinical Manufacturing Facility operates according to FDA cGMP Guidelines and with multinational health agencies around the world.
Wade Macedone, Chief Operating Officer at Andelyn Biosciences, talks about how process improvement and operational excellence play an important role in the future of cell and gene therapies.
Mayo Pujols, CEO of Andelyn Biosciences, discusses how companies are focusing on reliability and predictability to further advance this innovative therapy.
Recent applications of adeno-associated virus (AAV) mediated gene therapy have mainly focused on correcting recessively inherited diseases. What about dominantly inherited disorders? AAV could be a delivery mechanism for treating those, too.
Big Gains In FSHD Research: A Newly Published Model of FSHD And A Potential Gene Therapy To Improve Functional Outcomes
Facioscapulohumeral muscular dystrophy (FSHD) is the most prevalent dominantly inherited muscular dystrophy in the world. The new model aims to provide the basis for future studies to bring therapeutic options to patients with FSHD.
A gene known to repair damaged nerves also repairs damaged muscle, a team of investigators at Nationwide Children’s Hospital discovered.
Researchers have identified a key regulatory protein implicated in Galgt2 overexpression and began to elucidate its protective mechanism against muscular dystrophy.
Krabbe disease is an aggressive, incurable pediatric neurodegenerative disease caused by mutations in the galactosylceramidase (GALC) gene. The standard of care for presymptomatic babies is hematopoietic stem cell transplantation (HSCT); however, the morbidity and mortality of HSCT is high. A recent study published in The Journal of Clinical Investigation reports the successful treatment of Krabbe disease in a preclinical animal model using gene therapy.
Industry expert Mayo Pujols, CEO of Andelyn Biosciences, offers his perspectives on addressing the workforce challenges in the clinical manufacturing field.
Nationwide Children’s Hospital Affiliate Andelyn Biosciences Receives Significant Investment And Enters Into Strategic Partnership With Pall Corporation And Cytiva
Andelyn Biosciences, Inc, a contract development and manufacturing organization (CDMO) and an affiliate company of Nationwide Children’s Hospital, has received a significant, minority investment from Pall Corporation.
In May 2019, the U.S. Food and Drug Administration (FDA) approved a gene replacement therapy for the inherited, progressive neuromuscular disease 5q-linked spinal muscular atrophy (SMA). Approval included all children with SMA under the age of two years; however, the gene therapy had only been studied in children aged up to 8 months. In the new study, Dr. Mendell and colleagues from Nationwide Children’s and three other Ohio children’s hospitals report safety and early outcome data from 21 children (age 1-23 months) treated with onasemnogene abeparvovec-xioi in Ohio.
Andelyn Biosciences is already a world leader in gene therapy development and manufacturing thanks to foundational gene therapy research from its affiliate partner Nationwide Children's Hospital. Now, Andelyn has broken ground on a new 185,000-square-foot facility – slated to open in 2022 – that will expand its gene therapy manufacturing capabilities and Columbus, Ohio’s pioneering biotech reputation.
Quite often, clients focus primarily on capacity availability, scheduling, and commercial terms. Read an industry experts views on overlooked considerations when partnering with a CDMO and the challenges of building a new facility during a pandemic.