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In the news |  22 March 2024

How to overcome the challenge of differing digital maturity levels in BioPharmaceutical supply chains

In a new co-written byline for Drug Development and Delivery, Harlan Knapp, Head of Digital Manufacturing Solutions, and David Brick, formerly Senior Director of Data Services at IDBS, explain how the use of flexible, cloud-based data sharing platforms can enable more efficient collaborations among BioPharmaceutical manufacturing partners with differing digital maturity levels and varying data management capabilities.
Read more in this excerpt of the article, originally published in Drug Development and Delivery. Shared here by permission. 

The past decade has brought new challenges to the single-source manufacturing model with the adoption of more flexible manufacturing networks, utilizing in-region capacity through a combination of outsourcing to contract organizations and the de­ployment of more flexible facilities utilizing single-use technologies

This evolution toward a network of partnerships between drug sponsors and contract manufacturers has highlighted the challenges of technology transfer, capturing, monitoring, analyz­ing, and reporting manufacturing process and quality data as it relates to data integration between organizations.

Predictably, data sharing becomes more cumbersome as more partners and technologies are involved – with impacts not just on incidental process data, but also on critical quality and approval data that can impact product release and regulatory fil­ings. As a recent BioPhorum report (Vision for Digital Maturity in the Integration Between Biomanufacturers and Partner Organi­zations) indicates, companies share data at different levels of dig­ital maturity depending on their specific business priorities and internal digital maturity.1 Therefore, the efficient and timely de­livery of therapeutics with complex manufacturing needs cannot be achieved by simply unifying the entire pharmaceutical land­scape within the most advanced digital maturity level. A better approach is to implement a flexible data-sharing platform that can accommodate partners with different data management ca­pabilities.

Read the full article on the Drug Development & Delivery website.

About the authors

David Brick headshotDavid Brick is Senior Director of Data Services at IDBS and has more than 30 years of experience in consulting, project management, data management and data warehousing for reporting and analytics applications. He has spent more than 20 of these years focused on pharmaceutical and biotech manufacturing and process development. As part of Skyland Analytics and IDBS, he has been responsible for data management, connectivity and sharing aspects of PIMS as well as technical implementation project delivery. Prior to joining Skyland Analytics, he served as Director, Professional Services for Dassault Systèmes BIOVIA (and its predecessors Accelrys and Aegis Analytical) where he had responsibility for all implementation activities for Discoverant, the world’s leading informatics software for Life Science manufacturers, and for the Nexus data access and aggregation components of the product. His clients included more than 50 process development and manufacturing facilities worldwide. He earned a BSc in Applied Mathematics with University Honors and a MSc in Statistics from Carnegie Mellon.

 

Harlan Knapp - Digital Manufacturing Solutions at IDBSHarlan Knapp is Head of Digital Manufacturing Solutions at IDBS and drives digital solutions for tech transfer and manufacturing control strategies to help accelerate approvals of therapeutics. He has spent the past 20 years in the biopharmaceutical industry in a variety of roles, including R&D, manufacturing, product development, management, sales and C-Suite business development. He earned his MSc in Biology from Eastern Washington University.

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