Bionova Scientific is a full-service biologics contract development and manufacturing organization (CDMO) with a staff of more than 100 employees in the heart of the San Francisco Bay biotech cluster. It operates a state-of-the-art 11,000 square foot commercial-ready GMP biologics manufacturing facility located within its 57,000 square foot headquarters, which also houses process development and analytical laboratories. Bionova facilities also include a second 22,000 square foot building with GMP warehouse space.

A portfolio company of Great Point Partners (GPP), a Greenwich-based private investment firm focused exclusively on the health care industry, Bionova announced as this story went to press an agreement to be acquired by Asahi Kasei Medical (see side bar below).

Contract Pharma recently talked with Bionova’s chief executive officer, Darren Head, about the company’s beginnings and its rapid growth led by a driven team of scientists dedicated to improving patients’ lives.

Contract Pharma: What led you to your role as chief executive at Bionova Scientific?

Darren Head: I’ve had the privilege of working at some great CDMOs before Bionova, most recently leading Cytovance and MaSTherCell. Through those two companies, I developed a relationship with Great Point Partners (GPP), a private equity firm that specializes in life sciences services companies, such as CDMOs. When GPP was looking at an investment in Bionova, they asked me to participate in the due diligence process. I was deeply impressed with the scientific talent at the company and saw great promise for its future if they could secure greater access to capital. In this business, anyone with money can buy the latest technology and build a shiny facility, but the most critical and hardest-to-find building block is talented people with scientific know-how and discipline. Bionova had a stronger scientific core than any CDMO I had seen.

I also saw that clients loved Bionova. In many cases, the only frustration we heard was that clients wanted to stick around with us for manufacturing, but we did not yet offer that capability. We saw a great opportunity to support Bionova so the company could provide a full range of CDMO services for its clients.

So, GPP made the investment in Bionova and then I was named chairman, where I got to work closely with the founders, Amy Kong and Chung Chun. As the company continued its rapid growth and we moved closer to Amy and Chung’s vision of adding GMP manufacturing for recombinant protein biologics, the founders were itching to get back to their scientific roots and asked me to move into the CEO role.

CP: Can you share a bit of background and history on the company?

Head: The company’s history is really Amy and Chung’s story. They were colleagues and friends at prior biotech companies, including Amgen, Abgenix and Boehringer Ingelheim. Amy and Chung had established very strong scientific reputations and decided they wanted to build their own company. As the story goes, they wanted to build a science-based business where clients came first and mutual trust was a cornerstone.

Amy and Chung set out to find like-minded, highly talented people and bring them together in an environment that allowed for entrepreneurial spirit and agility and personal touch. In retrospect, it is amazing the level of scientific talent they were able to attract to this little start-up company. They also invested heavily in technology, so their team would have the best tools with which to do their work.

But their real focus was to build a workplace where people were empowered and energized to do great work together for clients—where they would not let big company meetings and bureaucracy slow them down. They were committed to a responsive, caring culture that gave all clients confidence that their critical projects would be handled well. That was Amy and Chung’s vision then and it very much lives on in Bionova today.

That early vision worked and Bionova was able to build up a portfolio of clients, small and large, including many in the Bay Area. Those early clients proved to be very loyal, and many still work with the company today. In fact, we recently completed our first clinical GMP run for one of our early clients. Through word of mouth, those loyal clients also sent many others our way, so the company was able to sustain a rapid growth trajectory. In 2019, GPP got involved and made an investment which enabled us to construct a new GMP manufacturing facility, setting us up for the next phase of growth.

CP: It sounds like science and culture are equally important parts of the company’s success. How do you sustain the culture as the company grows?

Head: The nice thing about leading a company in this industry is that the inspiration is served to us on a silver platter. Every day, we get to work with clients who have developed an innovation that could save the lives of thousands of patients, or improve the quality of life for millions of people. The fact that we get to contribute to making that happen for patients with cancer, autoimmune disease and many other disease areas makes it much easier to be motivated to come to work every day, stay late or work on a weekend. In a world that can seem pretty cynical, it’s refreshing to know that our work really does make a difference for people.

Our founders and our current leadership team do not take this for granted. We remind our team every day that their work matters, that their extra effort could lead to a life-saving drug getting to market sooner and therefore saving a life that might not otherwise have a chance. As CEO, one of my main jobs is to remove obstacles that get in the way of our team. Sometimes that means making an investment in technology, but more often than not, it means helping our various groups continue to communicate and to focus on what’s important.

CP: What are some of the exciting areas you’re seeing in biologics these days?

Head: Well like I said, Bionova was built around a deep core of science and our focus was recombinant protein therapeutics. As we attracted such a strong team, this naturally led to us helping clients with their most difficult programs or difficult-to-manufacture biologics. There are lots of small “virtual” biotechs that are focused on discovery and are working on some exciting concepts such as bispecific, trispecific, antibody fragments, enzymes, ADCs and non-traditional protein molecules. These companies do not want to invest in headcount and facilities to handle the development work and even more for manufacturing, so they are more likely to rely on companies like Bionova to act as their outsourced development and manufacturing partner. As we helped one client after another with this kind of work, we became the experts in that space, so we tend to see a lot of really exciting concepts coming through the building. We’re finding that even large companies are calling on us to leverage our special expertise in this area. I wish I could share specifics of some of the programs in the works, but client confidentiality is non-negotiable!

CP: You built a new GMP manufacturing facility during the Covid pandemic. What were some of the challenges you faced?

Head: Our board approved the investment in the GMP facility just a few months before the rest of the world came to a standstill due to COVID. So, we were deep into our planning in Q1 2020 when we suddenly had to deal with the disruptions the pandemic would present.

Thankfully, our team was excited to push forward, and they did a remarkable job rallying to sustain the project’s momentum. A complex project like this requires an extraordinary level of collaboration and coordination, across our own internal teams, with architects, engineers, contractors, equipment and technology providers, government officials, and so on. It wasn’t easy, but I am so grateful to everyone involved for the way they came together and stayed focused on getting the job done.

We broke ground in July 2020 while the rest of the world was getting used to “work from home.” A little over a year later we had a state-of-the-art, commercial-ready biologics manufacturing facility that had been completed on-time and on-budget. It is really a tribute to the entire team and something we are immensely proud of.

As an aside, what sometimes gets lost in this conversation is that we also had a rapidly growing CDMO business with critical cell line development, process development and other projects that had to keep moving. The pandemic also triggered a new wave of projects for COVID-related treatments, so our development teams were operating at full capacity. Our teams demonstrated great commitment and perseverance to keep our client programs moving forward while also supporting the facility design work. It was a very difficult period for everyone to go through, but the end-result is really awe-inspiring.

CP: You’ve mentioned the new GMP facility a few times. What more can you tell us about it?

Head: In designing the GMP facility, we were fortunate to have several team members who had operated GMP facilities for other companies, so we had a very good idea of what we did and did not want. We also knew that we could not accurately predict where our clients or the industry would take us, so we focused on versatility and future-proofing as much as possible.

This led us to an all single-use, open ballroom design. This design would give us maximum flexibility to handle different scales of process, to handle complex molecules that might require four or five purification steps (as opposed to the usual three), perfusion processes, or different hold times/temperatures. We designed that flexibility into the facility so we could bring nearly any piece of advanced equipment in while supporting it from a robust quality systems standpoint.

One of the nice things about building a brand-new facility with no legacy issues is we are able to benefit from all the latest and greatest technologies and can bring in new equipment and technology faster than any CDMO I know of. While we are doing early-stage clinical manufacture today, we have the systems and infrastructure to handle commercial manufacture when the time comes, so we can support clients all the way through the product life cycle.

We also designed the facility to address current and future regulatory requirements. The biggest change we face from a regulatory standpoint is the globalization of requirements. If we want to support clients in front of the FDA, EMA and other jurisdictions, our facility must accommodate ALL requirements from ALL jurisdictions. We must also address future proposed requirements. This flexibility is built into our design.

Another dimension of the facility that was very important to us was visibility. As a company, open, collaborative relationships with clients are a fundamental part of our mindset. We know that clients are hungry to know what is happening with their products and projects, so we sought to design visibility into the facility. The production suites and labs have large viewing windows and we have a large, bright viewing area from which clients can view their product being manufactured. We also have secure cameras throughout the facility, so we can allow clients to look in on their processes when they can’t get into the suite physically.

I’d be remiss if I didn’t also mention how our team plays into the success of the new GMP manufacturing operation. We now have the same scientists who develop a client’s process participate in the transfer of the process to manufacturing and are available for on-the-floor support and troubleshooting. This allows us to ensure that processes are scaled-up seamlessly.

CP: Now that your GMP manufacturing facility is operational, what’s next for Bionova?

Head: We are very focused on operating the new facility and are very pleased so far with the results of our first few months’ worth of manufacturing activities. We are also in the early stages of planning our next expansion, which will focus on GMP plasmid DNA manufacturing. There is an enormous amount of activity in advanced cell and gene therapies and mRNA vaccine technology, and that brings with it an urgent need for new sources of high-quality plasmid DNA. We are applying our scientific expertise in process development, QC, analytical and GMP manufacturing and our facility design experience to respond to this demand with a new production facility to be launched in 2023. We’re looking to offer small-scale process development and bench material generation later in 2022, with pre-GMP and GMP production rolling out in 2023.

CP: You mentioned cell and gene therapies. You’re also involved with a cell therapy CDMO, correct?

Head: Yes, Cellipont Bioservices is another GPP portfolio company where I serve as chairman of the board. It’s interesting, because apart from the scientific focus (cell therapy vs. recombinant protein biologics), Cellipont is in many ways a carbon copy of a younger Bionova. Their core strength is their scientific talent and experience, which they combine with a great commitment to client service. Cellipont has assembled a great team and has some exciting expansion plans in the works. I expect them to become an important player in the cell therapy space over the next few years. 

Bionova to Become Part of the Asahi Kasei Group Will complement Asahi Kasei’s bioprocess consumables & equipment and biosafety testing services business. As this issue of Contract Pharma went to press, Bionova Scientific announced an agreement to be acquired by the U.S. arm of Asahi Kasei Medical, a core operating company of the Asahi Kasei Group (led by Asahi Kasei Corp. of Tokyo). The acquisition represents a strategic complementary addition to Asahi Kasei Medical’s bioprocess business, which is known for Planova virus removal filters, MOTIV inline buffer formulation systems, ViruSure viral safety testing services and Bionique mycoplasma safety testing services. With the acquisition of Bionova, Asahi Kasei adds a full-service biologics CDMO in the heart of the San Francisco Bay biotech cluster. Closing of the acquisition is subject to receipt of necessary regulatory clearances.