Clinical Manufacturing

Andelyn Biosciences provides clients with a broad range of viral vector manufacturing platforms and solutions, including AAV and Lentiviral 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 20+ years that utilize the latest manufacturing optimization tools to maximize efficiencies and accelerate timelines. Andelyn is compliant with global regulatory bodies and has supported 75+ IND’s for viral vector- based gene therapy products around the world.

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Why Andelyn for Clinical Manufacturing?

Andelyn Biosciences is a pioneering biopharmaceutical CDMO born out of Nationwide Children’s Hospital. Our experts are globally recognized thought leaders with 20+ years of experience with AAV, Lentiviral and plasmid manufacturing. We have partnered in over 75+ 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 plasmid, AAV, and Lentiviral products provide your organization with the clinical manufacturing support you need to develop new gene therapies.

To learn more about our cGMP manufacturing processes and services, contact us 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.

20+
YEARS
More than 20 years of experience with plasmid, AAV and Lentiviral vector manufacturing.
ADVANCED TECHNOLOGY
State-of-the-art manufacturing facilities.
GLOBALLY REOGNIZED
Our thought leaders are making impacts around the world.

Accelerating Timelines of Innovative Therapies

Andelyn platform processes and its respective cell lines/MCBs are designed to optimize production yields and accelerate timelines. Our deep expertise in both innovation and tech transfers allows for tremendous flexibility for adherent and suspension based manufacturing at scales from 1L to 2000L.

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 plasmid, AAV and Lentiviral based products and plasmids. Andelyn ensures that our clients receive the reliable, responsive manufacturing services needed to develop the next generation cell and gene therapies to cure prevalent and rare diseases.

To learn more about our cGMP manufacturing services, contact us 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.

Andelyn provides manufacturing services from concept to commercialization

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.
UPSTREAM PROCESSING
Adherent mode: CS10/HS36
UPSTREAM PROCESSING
Suspension mode: SUB up to 200L
DOWNSTREAM PROCESSING
Wide variety of purification technologies: Chromatography, TFF, filtration, etc. scalable up to 2000L
FILL AND FINISH
Manual, semi-automated and automated filling options
FILL AND FINISH
2ml, 5ml and custom CZ and polypropylene vialing