Clinical Manufacturing

Andelyn Biosciences provides clients with a broad range of viral vector manufacturing platforms and solutions, including AAV adherent and suspension systems along with plasmid manufacturing. We support our clients throughout every step of cGMP manufacturing – from pre-clinical trials of gene-modified products and cell therapies to commercial production.

Andelyn Biosciences also focuses on risk mitigation by introducing processes established over the past 15+ years that utilize the latest manufacturing optimization tools to maximize efficiencies and accelerate timelines. Andelyn is compliant with global regulatory bodies and has supported 60+ IND’s for viral vector-based gene therapy products around the world.

Clinical Manufacturing
Subculturing cells in the CMF

What Andelyn Offers Our Partners

Andelyn Biosciences partners with global biotech, biopharmaceutical, hospital, research institute and academic/universities worldwide to offer a wide variety of research grade, toxicology grade and cGMP clinical manufacturing services. Our development and pharmaceutical services include manufacturing and QC/QA testing services at all stages.

At our ISO-certified facility, we operate in adherence to cGMP practices to design, develop, test and manufacture AAV based products and plasmids. Andelyn ensures that our clients receive the reliable, responsive manufacturing services needed to develop the next generation gene therapies to cure prevalent and rare diseases.

Andelyn Provides Support From Preclinical Through Phase Ill Clinical Manufacturing

Andelyn Biosciences GMP Facility
A biowelder aseptically connects bioprocessing bags to HYPERStacks

Andelyn’s full spectrum service offering allows for tech transfer, custom creation of viral vectors and plasmids based on your exacting requirements and manufacturing pre-designed products.

Our clinical manufacturing capabilities include:

Upstream Processing:

  • Adherent mode: CS10/HS36
  • Suspension mode: SUB up to 200L 

Downstream Processing:

  • Wide variety of purification technologies: Chromatography, TFF, filtration, etc. scalable up to 200L 

Fill and Finish:

  • Manual filling of up to 900 vials per session
  • 2ml, 5ml and custom vialing with customizable volume/stoppers/vials  

Why Use Andelyn Clinical Manufacturing?

Andelyn Biosciences is a pioneering Gene Therapy CDMO born out of Nationwide Children's Hospital Viral Vector Core. Our experts are globally recognized thought leaders with 15+ years of experience with AAV vector manufacturing. We have partnered in over 60+ US, EU and ROW clinical trials and innovated Zolgensma- the first FDA approved Gene Therapy for SMA.

Our advanced technology, state-of-the-art facilities, and decades of experience in manufacturing AAV products provide your organization with the clinical manufacturing support you need to develop new gene therapies.

To learn more about our cGMP manufacturing services, contact us online to speak with one of our experts right away. We can discuss your needs for clinical manufacturing in more detail, and help you understand the benefits of working with the experts at Andelyn Biosciences.