The State of Biomanufacturing Today: Why Digital Change Can’t Wait

by Steven Barash | posted on December 19, 2024

I’ve been there. Leading IT and technical operations for CDMOs and collaborating with biotech companies, I witnessed firsthand what happens when the CDMO digital infrastructure doesn’t keep up with the pace of innovation and customer demands and expectations.

Biotechs are innovating faster than ever, pushing groundbreaking therapies through development to the clinical, and rightfully so, expect tech transfers to accelerate. However, their success relies on how quickly CDMOs can deliver and share manufacturing milestones, process and CMC analytics, and disposition timelines delivered in paper forms, emails, and Excel sheets, and relying on CDMOs to enter data manually across disconnected systems. I’ve worked with many teams (material handling, QC, manufacturing groups, etc…) and witnessed them, more than once, entering the same information—by hand—into LIMS, MES, Excel spreadsheets, and sometimes paper logs to meet customer expectations.

This redundancy doesn’t just slow teams down; it creates frustration among teams, delays tasks, and adds unnecessary risk of manual errors. And yet, the CDMO still needs to provide this data back to the biotech—data for regulatory submissions, CMC process analytics, and regulatory decisions. Without integrated systems, delivering that data becomes an enormous challenge. And for biotechs, this lack of transparency means delayed decisions and stalled progress. “How can we release this product if we can’t see our data?” is a question I’ve heard far too often.

The urgency becomes even greater when we consider the growing demand of Advanced Therapy Medicinal Products (ATMPs) in the clinic, thereby relying on tight collaboration between the CDMO and its Biotech customers to accelerate technology transfers and initiate clinical manufacturing campaigns. Removing tech transfer delays from the equation has never been more important.

If CDMOs want to meet the demands of their biotech partners, they need to mature their processes and manufacturing platforms by embracing digital tools and technologies and investing in modernizing its digital infrastructure to establish systems that eliminate redundancies, integrate workflows, and prioritize collaboration and transparency.

If you think the status quo is an option and relying on paper-based and disparate systems to manage your operations, I have to tell you that the cost of doing nothing is far greater. Beyond impacting the patient experience, each delay in a tech transfer and manufacturing presents missed opportunities, stalled growth, and increased operational costs, holding your organization back while competitors invest in native digital platforms to accelerate their operations. 

Don’t let it be this way–options exist, such as a unifying platform to initiate digital transformation without a rip-and-replace approach. It’s time to accept digital transformation is required to streamline your operations, maintain operational expenditures,  strengthen your partnerships, and position yourself as a trusted leader in the industry.

Let’s stop living with these challenges. Let’s fix them—together—by driving a customer-centric experience through data sharing. Please contact me or an L7 team member if you would like to learn more about our unique approach and how we can help enable a faster and more efficient tech transfer. info@l7informatics.com Subject: tech-transfer