The DIGITAL CDMO® Platform

We are diligently working to harness the power of modern technology to maximize the value of data, drive insights from it, ensure critical data assets are compliant and secure, and provide unmatched data insights for clients through The DIGITAL CDMO® Platform.

Setting the Standard

What is different about The DIGITAL CDMO® Platform?

Collaboration

Andelyn Biosciences believes that the “C” in CDMO stands for “Collaboration”. Data and technology are key components transcending the industry from one that has been transactional and sometimes combative, historically, to one geared toward partnership and shared successes.

Data & Data Integrity

Legacy CDMOs struggle to correlate data from the manufacturing process with lab test results, leading to inefficiency and wasted time.
Data integrity is a chief compliance and security priority. Data Integrity by Design was a primary driver for the implementation approach for The DIGITAL CDMO® Platform. Clients’ data enters a secure chain of custody as part of Andelyn’s electronic assets.

Multiple Sources

A significant challenge for the biotech community, especially when leveraging multiple partners to a product’s data from its inception through its development, including CDMOs, CTOs, and CROs, is contending with disconnected data. It becomes impossible to have complete visibility of a product’s data from its inception and throughout the development lifecycle. Andelyn recognizes that we are both a data company and a manufacturer of gene therapy products, and we produce physical products and data for our clients.

Optimization

The DIGITAL CDMO® Platform brings an optimized result, ranging from higher client satisfaction and the ability to utilize data early in drug development to drive towards optimal production.

Our Platform

Setting Us Apart

What is different about The DIGITAL CDMO® Platform?

Andelyn continues to build out The DIGITAL CDMO® Platform through significant investment in traditional industry-recognized solutions, yet with a design that leverages the data foundation to enable secure collaboration with our clients and to build advanced capabilities leveraging AI.

Critical Quality / GxP Applications
Trackwise Digital for QMS/DMS
Compliance Wire for LMS
LabVantage LIMS
Blue Mountain RegulatoryAsset Manager for CMMS
Box GxP Validated Repository for GMP Document Sharing / Co-Authoring
Tetrascience GxP Platform for Enabling Data Integrity by Design
Facilities

Our Facilities

Our two facilities in Columbus, OH, are meticulously designed to support your project's evolution from concept to reality.  We're not just about meeting today's needs, but also about anticipating future demands with ample capacity to support our clients today and the ability to expand our operations as needed.

Explore the unique role each of our built-for-purpose centers plays in advancing cell and gene therapies, setting new industry standards for excellence and partnership.

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