Center for Breakthrough Medicines Moves Full Steam Ahead in Q1 with Multiple Strategic Partnerships

By Mark Terry, Lead Writer at BioBuzz

King of Prussia, Pa.-based Center for Breakthrough Medicines (CBM), a contract development, manufacturing, and testing organization (CDMO) has had the “pedal to the metal” this year with a range of strategic partnerships. The company’s Co-founder and Chief Business Officer, Audrey Greenberg, spoke with BioBuzz about the company’s activities and strategy moving forward.

“The reason we love strategic partnerships is that the cell and gene therapy (CGT) space really requires collaboration,” Greenberg told BioBuzz. “We’re in the first inning of cell and gene therapy and the cost is high, the production is inefficient, and we have to find better ways. And the only way to find better ways and lower costs is through these collaborations.”

Since the beginning of the year, CBM has reported a string of agreements. In January, it signed a licensing deal with UK-based Autolomous, a developer of critical manufacturing management systems for cell and gene therapies.

“The reason that’s so important,” Greenberg says, “is the future is all digital. You need digital batch records. You need artificial intelligence to help you manufacture more efficiently, understanding the surrounding environment that you’re manufacturing in and what makes the best optimal batch and having data to help support that in decision making.”

Greenberg noted that if you were to take paper applications to the FDA, “you’re having truckloads of paper.” And because paper doesn’t have a search function, it can be almost impossible to find the specific data you’re looking for. “We’re lucky that we’re building our suite and we put all the fiber and infrastructure in place. We’re really lucky to partner with Autolomous now to automate everything to put all the digital infrastructure in place now so we don’t have to rip down the walls and ceiling or take the systems apart later.”

Later in January, CBM signed a deal with Boston-based Asimov, a mammalian synthetic biology company creating tools to design living systems. CBM licensed Asimov’s clonal HEK293 suspension cell lines to produce viral vectors.

Then in February, CBM inked a partnership with Virion Therapeutics. CBM will partner with Virion’s checkpoint modifier programs, including the First-in-Human VRON-0200 immunotherapy for chronic Hepatitis B Virus (HBV) infection.

In March, CBM announced two more deals. The first was with San Diego’s Nucleus Biologics, a provider of custom cell culture media solutions for CGT, and Stoic Bio, a provider of sustainable technology for cell media manufacturing. The agreement made Nucleus the preferred supplier of cell culture media and other critical biological solutions for CBM.

Greenberg says, “The bottleneck in many of these early-stage CGT companies is manufacturing and development. So we’re here to help them with that. The other factor in terms of Nucleus Biologics and Stoic Bio is that another bottleneck in the industry is getting good media to help grow your cells in the cell culture media and other biologic solutions. And that was exacerbated during Covid-19. It was very difficult to procure some of those media and cell culture solutions. So the partnership with them allows us to be a preferred partner of choice.”

Only days later, CBM entered into a strategic partnership with New York-based Cell One Partners, a strategic consulting firm in support of CGT companies.

The relationship with Cell One was born out of a 2022 partnership CBM forged with SK Inc. CBM received $350 million in equity financing from SK, an investment holding company for SK Group, a leading conglomerate in Seoul, South Korea. SK and CBM are working to form the world’s largest end-to-end CGT CDMO.  

“They’re our largest investor,” Greenberg says, “and it’s a great partnership, not just for the deep pockets, but they bring cell and gene therapy companies that they’re invested in to us for manufacturing. They also have a good culture that we’re part of. We’re happy with the SK partnership.”

Greenberg adds, “The reason and the thought process behind partnering with Cell One is that they are providing what I would call the back office and the intellectual horsepower behind virtual biotechnology companies. They partner with a scientist that wants to launch a product and they find a way to do that in the most capital-efficient manner by being their executive function as well as outsourcing to us as their CDMO. They also bring CRO partnerships to the table. So you can essentially have a virtual biotechnology company with a PO box that can run their business through these partnerships.”

In many ways, this handful of announced partnerships is only the tip of the iceberg. Greenberg notes that they have 20 to 30 partnerships, most of which are confidential. She says, “What’s interesting about some of those is that in addition to being a service provider, we’re also an equity investor in some of those companies. So we really do see a fortuitous relationship when we’re able to work together — it creates an alignment of interest.”

Clearly a busy and exciting time for CBM, Greenberg says that it’s an interesting time for biotech. “You have a disconnect between the science and the valuation. For a long time, there was capital flowing into the space and the science was at a very early stage. Now we’re seeing a lot of clinical and commercial progress, but what we’re not seeing the capital markets necessarily catching up with that.”

And why is that important? Greenberg says it’s because CBM is there to help the companies stretch their capital growth. “You don’t have to build your own bespoke manufacturing plant, which was what was happening in 2019 and 2020. Companies thought they would get a higher valuation if they built their own captive manufacturing.”

But that can cost $1000 to $2000 per square foot and take three to five years between location, zoning approval, build qualification, procuring equipment, and hiring staff. “Let the biotechs focus on the science and let the Center for Breakthrough Medicines be their development and manufacturing partner to put their capital to work more efficiently,” Greenberg says.

As the company moves forward in 2023 and beyond, CBM is focused on being the partner for companies that may have difficulty raising capital. Also, Greenberg says, CBM is building next-generate suites, which will allow it to have significantly more capacity.

Instead of just one batch per month or one every two months, they expect they will be able to get “30 to 36 batches out of those suites. And that’s important because it really does lower cost and make the process a lot more efficient. We’re always looking to redesign the process and rethink how we’re making things,” Greenberg says.

The company is also working on getting its digital infrastructure in place. Also, Greenberg points out, “Keeping employees engaged. We went from 100 to 400 people really overnight last year. So making sure with this group of employees that our culture is resonating is important and that we’re connecting to the patient population. You really don’t get any closer to the patient than you do in cell and gene therapy. So inviting patients to our site, letting our employees feel connected and mission-driven, feeling good about what they’re working on every day is important to us.”

When asked about the Philadelphia area, Greenberg says she’s “one of the biggest fans of spreading the Cellicon Valley and Philadelphia story and gospel around the United States.” She notes that all the big pharma companies are within an hour’s drive of Philadelphia.

“I think there’s a lot that Philly has going for it from talent to a patient population to the academic and medical institutions, proximity to an international airport, and cold-chain storage. I love the Philadelphia story, where in the last five years we’ve increased in the rankings from number 10 to number five. And I’m really hopeful that we’ll get to number one, at least for cell and gene therapy. It’s an exciting time for Philly.”

About the Center for Breakthrough Medicines

The Center for Breakthrough Medicines (CBM) is a cell and gene therapy contract development and manufacturing organization (CDMO) uniquely positioned to enable pharma and biotech companies to develop, test, manufacture, and market life-saving therapies and treatments on a global scale. Ideally located in the heart of Philadelphia’s Cellicon Valley, CBM has assembled the most accomplished cell and gene therapy experts in the world, armed with cutting-edge and innovative technologies, to offer scalable, best-in-class pre-clinical through commercial manufacturing capabilities, including process development, plasmid DNA, vector manufacturing, cell banking, cell processing, and a full suite of complementary and standalone testing and analytical capabilities.

Purpose-built and patient-driven, CBM was designed from the ground up to be a more-effective CDMO, providing single-source, end-to-end solutions to deliver true partnership and unprecedented value to its customers through teamwork, transparency, and speed-to-market dedication.

Learn more at https://breakthroughmedicines.com/