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Andelyn Biosciences Selects TetraScience as a Strategic Partner for Innovation in Therapeutics Development and Manufacturing

Andelyn Biosciences | August 26, 2021

TetraScience, the R&D Data Cloud company, announced today that Andelyn Biosciences, Inc. has selected the Tetra Data Platform (TDP) to build a cloud-native development and manufacturing service for its customers. As part of an Andelyn Biosciences initiative to create a Connected Plant that harmonizes data from building and facilities, process and manufacturing, and lab instrument sources, TDP will enable better compliance, easier analysis, faster decisions, and more agile operations. Additionally, Andelyn customers will benefit from secure, convenient access to harmonized data that is prepared for analytics and visualization.

As a Contract Development and Manufacturing Organization (CDMO) for cell and gene therapies, Andelyn must remain GMP-compliant and increase efficiency while leading the industry in the innovative services they provide to customers. By launching a Connected Plant, Andelyn will gain autonomous operation, predictive capabilities, improved process monitoring and control, and increased data integrity.

"Andelyn has been a pioneer in gene therapy with a 15-year history accelerating the development and manufacturing of innovative therapies to bring more treatments to more patients," said Bryan J. Holmes, Vice President, Information Technology at Andelyn Biosciences. "Together with TetraScience, we're transforming how we work with our clients, utilizing fully-digitized, cloud-native services to help connect all the plant and lab data created during complex development and manufacturing cycles."

Andelyn chose TDP for its unique ability to harmonize data from building & facilities systems, lab instruments, and process & manufacturing equipment. By replatforming the data to a future-proof managed cloud environment, Andelyn will benefit from enhanced GMP compliance and data integrity, improved time-to-value, and lower TCO. Additionally, with an open data cloud platform powered by TDP and the Tetra Partner Network, Andelyn will be able to leverage their preferred tooling for analytics while supporting their customers' data consumption needs.

"We're excited to partner with Andelyn Biosciences on their mission-critical data cloud initiative and accelerate their journey towards becoming a digital company," stated Chad Garrett, TetraScience CRO. "As an innovator in providing cloud-native development and manufacturing services to its customers, Andelyn Biosciences recognizes that harmonizing scientific data in the cloud and making it easily accessible to clients will transform the way CDMOs exchange data with clients."

Andelyn's initial deployment of TDP is focused on acquiring and harmonizing historical data across key sources while enabling enhanced data search capabilities. Moving forward, Andelyn expects to complete the rollout of the Connected Plant with additional data sources and instruments, and ultimately launch a groundbreaking digital CDMO experience for their customers.

About Andelyn Biosciences, Inc.
Andelyn Biosciences is a pioneering gene therapy company born out of Nationwide Children's Hospital, where the first FDA-approved systemic gene therapy was discovered. Andelyn is named in honor of two gene therapy pioneers who participated in pivotal Phase I clinical trials at Nationwide Children's Hospital 8-year-old Andrew and 8-week-old Evelyn. Bringing together more than 15 years of experience in AAV vector manufacturing, Andelyn is a full-spectrum Contract Development Manufacturing Organization (CDMO) that helps pioneer solutions that turn hope into reality. Our mission is to accelerate the development and manufacturing of innovative therapies to bring more treatments to more patients. We accomplish this by bringing scalability, capacity, efficiency and expert resources to manufacturing matrices, all to advance the development of viral vector-based therapeutics. Our capabilities include viral vector process and analytical development, small to large scale GMP manufacturing, fill/finish and QC/QA release testing through Phase III with plans to launch commercial services in 2022. Andelyn also offers plasmid manufacturing services, formulation development services and regulatory support.

Spotlight

Characterization and identification of glucuronide metabolites

This technical note demonstrates the comprehensive
characterization and confident identification of glucuronide
metabolites from hepatocyte incubations of midazolam. An
orthogonal fragmentation mechanism was applied to generate diagnostic fragment ions for confident identification of glucuronide metabolites

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Spotlight

Characterization and identification of glucuronide metabolites

This technical note demonstrates the comprehensive
characterization and confident identification of glucuronide
metabolites from hepatocyte incubations of midazolam. An
orthogonal fragmentation mechanism was applied to generate diagnostic fragment ions for confident identification of glucuronide metabolites

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