Insufficient Vendor Data Is Hamstringing Single-Use Adoption

By Tyler Menichiello, Chief Editor, Bioprocess Online

If you asked me a couple weeks ago to justify the slow adoption curve for advanced single-use technologies (SUT) and systems (SUS), I would have chalked it up to a lack of standardization or regulatory guidance. And while both are significant factors, I’ve come to realize they are manifestations of a much deeper issue.

Fundamentally, the adoption challenge facing SUTs is a data problem. Specifically, it’s a data infrastructure problem, rooted in the insufficiency and limited usability of vendor data packages, which passes the validation burden onto end users.

This was made apparent during April’s Bioprocess Online Live event on closing the adoption gap for advanced SUT, where we asked the audience where they think SUT adoption tends to get stuck. Nearly 62% of attendees cited insufficient vendor data (32.4%) and the validation burden of qualifying SUS (29.4%) as key reasons.

This Live event featured BioPlan Associates’ director of research, Katrina Cordovado, as well as Joshua Nelson, Ph.D., a senior material qualification specialist at Takeda, and Paul Priebe, a consultant and single-use bioprocessing technology expert. During the hour, it became clear that there is a demand for advanced SUT, but adoption is largely limited by the friction of conducting these validation studies.

Quantifying The Demand For SUT

In another audience poll, a combined 65% of respondents indicated that they would be “very willing” or at least open to replacing their existing SUS in a validated process. A little more than a quarter of the audience (30%) were reluctant to change systems due to the risk involved, and only 5% said they were unwilling to do so unless it was absolutely necessary.

To me, these numbers paint a picture of an industry that, for the most part, would be willing to adopt new SUT if they could do so seamlessly.

Interestingly, the demand for advanced SUT seems pronounced in the CGT space. Cordovado shared BioPlan survey data in which at least 30% of CGT facilities identified improvements in single-use materials as a critical area for innovation.

Nelson, who has worked to support manufacturing process qualifications for cell therapies, shared some insight as to why the demand for innovative materials is higher in this space. “Many of the materials they have to use based on the unique nature of cell therapy manufacturing are more or less lab-grade materials instead of full-on GMP, commercial-manufacturing-grade materials,” he said. “So, the amount of vendor data and information that’s available for these specific materials in that process is quite low.”

Understanding The Validation Burden On End Users

Only about 10% of our audience said they are “very confident” in vendor-provided data on extractables and leachables, but the majority (around 68%) described being “somewhat confident” in this data. On the bright side, this outweighs the roughly 20% of our audience who have little to no confidence in vendor data, but these survey results still reveal a perceived gap in the robustness of vendor data. The resulting work of filling in these data gaps is a significant barrier to adoption, one that carries a cost and can affect timelines.

In a recent “Better Biopharma” podcast episode, where the panelists joined me to continue our conversation from the Live event, Nelson approximated the cost of an extractables study to be roughly $30,000 to $40,000.

“It’s not inconsequential,” he said.

The cost tends to be higher for companies that don’t have an in-house testing lab for these studies. The timeline disruptions have improved, Nelson explained, but during the COVID-19 pandemic, companies were looking at six to nine months before they could even get a sample into a lab for testing.

Improving The Usability Of Vendor Data

While the absence or completeness of vendor data was highlighted as a primary hindrance for SUT adoption, our panelists revealed a subtler, more pervasive problem — the usability of available vendor data. It’s not enough for vendors to provide comprehensive data packages, which should be the bare minimum. If vendors truly want to reduce the friction of SUT adoption, they need to deliver this data in a usable format for end users, one they can easily upload into their systems.

“Many packages come in as lovely PDFs that have lots of beautiful text, but it’s very hard to automate the actual extraction of that information,” Nelson explained during the Live event.

Converting these data sets into workable digital formats can introduce errors, as Nelson illustrated with an anecdote about a faulty optical character recognition tool (OCR). “I most recently had an OCR that changed every instance of a six to a nine, which is terrible,” he said. “It really messed with the ingestion of that whole data set.”

On the end-user side, companies also need to be prepared to receive this data, said Nelson. He believes they should have a structured system in place to easily ingest new data and compare them to existing data sets to evaluate the functionality and quality parameters of a new SUT and determine whether it’s worth implementing or not.

A Message To Vendors

Based on our survey results and the conversation with these panelists, it seems clear that the main issue stalling advanced SUT adoption is the insufficiency of vendor data in terms of quality, availability, and accessibility.

Speaking on behalf of end users everywhere, Nelson delivered a message to vendors on our recent podcast episode. “Give us the data up front in a simple, tabular format,” he said. “Be responsive and ready to answer questions.”

At the end of the day, end users just want to understand what they’re using and be able to present that information to regulators, said Nelson. The easier vendors make that, the more likely users will be to adopt new SUTs as they become available.

Click here to watch the full Live event recording or to see specific segments from that event. If you’d like to hear the rest of the conversation, which was continued on the “Better Biopharma” podcast, click here.

You’ll find plenty of conversations with industry experts about a variety of topics. Stay tuned for new episodes, released every other Wednesday, and if you have suggestions for future conversations or topics, answer this quick 60-second survey to let us know what you’d like to see more of.