The DIGITAL CDMO™ Platform

Setting the standard: Why build The DIGITAL CDMO™ Platform?

Collaboration:

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

Data & Data Integrity:

Legacy CDMOs struggle to correlate data from the manufacturing process to lab test results, resulting in inefficiency and lost 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 one leveraging multiple partners, 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 lifecycles. Andelyn recognizes that we are a data company in addition to manufacturing gene therapy products. We produce physical products and data for our clients.

Optimization:

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

Setting us apart: What is different about The DIGITAL CDMO™ Platform?

Andelyn built The DIGITAL CDMO™ Platform through significant investment in traditional industry-recognized solutions, yet with a design geared towards building the data foundation allowing for secure collaboration with our clients and building advanced capabilities:

• SAP B1 for ERP
• Trackwise Digital for QMS/DMS
• Compliance Wire for LMS
• LabVantage LIMS
• Blue Mountain Regulatory Asset Manager for CMMS
• Box GxP validated repository for GMP document sharing / co-authoring
• Tetrascience GxP platform for enabling Data Integrity by Design

Settling in: What is the future of The DIGITAL CDMO™ Platform?

Andelyn is always looking for feedback on how to better serve clients.  We are exploring the following digital services for the year ahead:

• Providing clients with live video access to parts of the manufacturing process
• Ordering / E-Commerce portal to simplify and manage orders
• Data Exchange to facilitate real-time visibility of batch status and associated lab and investigation records
• Advanced Analytics capabilities on demand

Cyber Security

Connecting shop floor equipment and lab instruments to the network necessarily adds security and compliance risks – neither of which is acceptable for the standard of security and quality Andelyn requires. When Andelyn broke ground on its 185,000 sq. ft. Andelyn Corporate Center in 2020, Andelyn’s digital team began building The DIGITAL CDMO™ Platform in lockstep to ensure all Andelyn’s client data is secure and Andelyn operations are cyber resilient.

The DIGITAL CDMO™ Platform infrastructure and network are designed with a zero-trust approach with layers of security controls to ensure Andelyn’s specialized devices are networked. From a compliance perspective, each device is designated as “specialized” and therefore does not receive the same updates as a standard user device, which can cause complications validating these critical technologies.