“The best CDMO is the one you haven’t worked with.” says Audrey Greenberg.”That’s really unfortunate.. it’s not that hard to be a good service provider.”
Audrey is the Founder of Centre for Breakthrough Medicines, the innovative, Pennsylvania-based Cell & Gene therapy Contract Development and Manufacturing Organization (CDMO).
In the latest episode of PharmaSource podcast Audrey discusses her journey in launching a CDMO that put digital at the centre of operations right from the start:
“Digital infrastructure is an important piece that people underestimate.” say Audrey.
At a time when many CDMOs are not yet digitising their operations, Centre for Breakthrough Medicines (CBM) raised capital specifically to invest in our automation systems and digital batch records, she says.
“We put all the fibre in place so we have incredible bandwidth within our sites to fully automate the suites and have basically IoT information flow. This enables data analytics, AI, and real-time insights for clients.” she explains.
Audrey highlights the key role of Jeet Sakar, CBM’s VP Information Technology in implement digital manufacturing technologies into the organisation, in partnership with technology vendors such as Autolomous.
The cost of digitisation
Digitised operations are expensive for most CDMOs which generally prioritise increasing production capacity over retrofitting new technologies, Audrey explains.
“It’s expensive right now to raise capital and having to spend $1,000 to $2,000 per square foot on GMP manufacturing space, and then having to spend on top of that for automation and infrastructure improvements is not cheap. For CDMOs that built their suites 10-20 years ago, going back and fixing them involves not only costs but also lost revenue during the process.”
That investment up-front can lead to cost and time savings, says Audrey:.
“A lost batch can cost millions of dollars, and patients miss out on therapy. Integrating data from various sources—ERP systems, operator behaviour, even sleep patterns—allows us to predict outcomes. AI plays a crucial role in understanding factors that impact yield downstream.”
Audrey emphasise the importance of speed for companies developing new therapies. To move fast, she says, you have to start analytical early.
“We in-source analytical testing. There’s a lot of CDMOs that outsource their testing and analytics, but we do it in-house, and we do it early. So you’re not going to get to the finish line, and your potency assay gets dinged by the FDA. We work closely with the FDA and think tanks to accelerate platform technologies for approval. It’s about balancing speed with quality.”
Audrey will be speaking on the panel of our upcoming Women in Biopharma meetup ‘How to build your personal brand‘. Join the conversation on 18th September, Sign up here
New opportunities for Cell & Gene therapies
The regulatory environment is opening up for Cell & Gene therapies, say Audrey.
“The FDA has made a huge turnaround. From five therapies over five years to now expecting 25 therapies in a year, they’re focused on this technology. We collaborate closely with them, even training their staff. There’s hope for cancer and other conditions. New delivery mechanisms and gene-editing modalities will drive progress.”
Audrey sees “green shoots of opportunity” for biotechs looking for funding.
“I’m excited about the rest of 2024 and certainly heading into 2025 I think it’s going to open up in a huge way – I’m excited about the future.”
She advises that investors seek trust and execution. “Start with a clear value proposition and a solid business plan. Build a strong management team—people matter. Understand each investor’s priorities and tailor your pitch. Show growth, align with their strategy, and address unmet needs.”
Collaborative regional partnerships
Audrey plays an active in Pennsylvania ‘Cellicon Valley’, working closely with stakeholders to create a vibrant, collaborative life sciences hub.
“’Location, location, location’” is the biggest phrase in real estate, but it’s true in biotech, more than anything, you need collaboration, so having proximity is huge.”
“CBM collaborated with the University of Pennsylvania (Penn) on gene therapy research and manufacturing. These collaborations support startups, provide resources, and facilitate knowledge exchange.”
“I have always really been driven by a passion for innovation and new business models: growing the economy of the cities that I live in, and finding a way to do a ‘triple bottom-line’ approach: supporting not only my career but also doing something that creates a better society, and doing it environmentally.”
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