The Andelyn Difference
“What’s in a name?” the saying goes. In this case, much more than meets the eye. Andelyn Biosciences is much more than a corporate name for a biotech business. For this innovative biotech organization, the patient always comes first. Inspired by two young gene therapy pioneers Andelyn Biosciences is a combination of the names of the children who participated in the momentous Phase I clinical trials at Nationwide Children’s Hospital.
In 2006, eight-year-old Andrew Kilbarger underwent the U.S.’s first-in-human investigational gene therapy for Duchenne muscular dystrophy. Later in 2015, at only eight weeks old, infant Evelyn Villarreal received experimental gene therapy for spinal muscular atrophy. With its hybrid name, the organization seeks to honor those who participated in trailblazing research and have made gene therapies feasible for patients today.
What Andelyn is capable of
With over 15 years of experience in gene therapy research, Andelyn Biosciences brings pioneering solutions that turn hope into reality. By expediting the development and production of leading-edge therapies, more patients than ever before can now be treated. As a full spectrum gene therapy partner, Andelyn Biosciences supports patients from preclinical through Phase 3 trials. With the following capabilities, patients can be assured they are receiving treatment that has a consistent quality and is in compliance with national and international regulations:
- Clinical Manufacturing: Andelyn Biosciences uses state-of-the-art manufacturing optimization tools to expedite timelines and increase efficiency. With the wide range of viral vector manufacturing platforms and solutions, clients have access to AAV adherent and suspension systems as well as plasmid manufacturing.
- Process Development: By following rigorous process development guidelines, Andelyn Biosciences ensures products are made in an aseptic environment, meet quality specifications, and are ultimately commercially viable, safe products.
- Viral Vector Core: Reserved for preclinical research studies that support the development of future clinical AAV gene therapy products, the Andelyn Biosciences viral vector core laboratory uses cutting-edge equipment, time-tested techniques, and advanced design concepts to provide viral vector development and manufacturing services.
- Plasmid Manufacturing: With over 20 years of experience in plasmid manufacturing, clients can request batches of any size. From small trials to clinical-scale plasmid production, all manufacturing adheres to GMP compliance for best practices in plasmid production.
- Quality Control: Products produced by Andelyn Biosciences meet strict quality metrics by using the latest technology and ensuring the personnel is well trained. Through a quality control laboratory, production is accurate, reproducible, and reliable, ultimately resulting in safe products that are suitable for clinical use.
What our capabilities aim to do
Over 15 years ago when GMP facilities were unheard of at children’s hospitals and gene therapy research was a rarity, Andelyn Biosciences was at the forefront of its field. Now, almost two decades later, the organization’s aim to make a difference in patients’ lives through cell and gene therapy continues to be the same. With its life-changing gene and cell-based therapies, Andelyn Biosciences continues to make scientific advancement that supports the future of children’s health. Their enthusiastically collaborative approach to improving the health of many, uses leading-edge technology and peerless compliance with regulations, making the organization highly reliable and exceptionally accountable.
Andelyn Biosciences provides a range of research-grade, toxicology grade, and cGMP clinical manufacturing services to partners worldwide. By providing partners with reliable and responsive manufacturing services, Andelyn Biosciences continues to aid the advancement of gene therapy and research into rare diseases. Ready to improve your gene therapy research? By partnering with Andelyn Biosciences you have access to innovative manufacturing capabilities as well as being part of the development of therapies for incurable diseases and rare disorders.
To learn more about how to partner with Andelyn Biosciences and work towards improving human health, contact us.