Leveraging the Tenacity of Biotherapeutics Development Experience to Build a Dynamic CDMO

Tanvex BioPharma USA, Inc. (formally La Jolla Biologics, Inc.) was founded in 2011 with a focus on developing biosimilar products. Over the following decade, the company brought in advanced technology and developed strong capabilities in process and analytical development, formulation, GMP manufacturing and regulatory affairs. The company is now applying its experience to help drive the success of customer programs through a newly established contract development and manufacturing organization (CDMO) business, Tanvex CDMO, located in a state-of-the-art facility in the dynamic San Diego, California, biotech hub. In this Q&A, Tanvex CDMO's Chief Operating Officer John R. Mosack discusses the company’s history leading up to this recent pivot, the unique strengths the organization has built up through its own journey, and the vision for providing unique and differentiating support to biopharma customers with all kinds of development and manufacturing programs, particularly biosimilars, in conversation with Pharma’s Almanac Editor in Chief David Alvaro, Ph.D.

David Alvaro (DA): To start things off, can you share some background about Tanvex BioPharma and how the company’s experience set the stage for the emergence of the Tanvex BioPharma USA CDMO business?

John Mosack (JM): Tanvex BioPharma USA, Inc, (formerly La Jolla Biologics, Inc.) was founded in 2011 with the mission of developing biosimilars to enhance access to biologic drugs for the broader public at more affordable costs. Within its portfolio of biosimilars, Tanvex BioPharma has prominently featured TX-01 and TX-05, which are proposed biosimilars for filgrastim/Neupogen® and trastuzumab/Herceptin®, respectively. Over the past decade, Tanvex made significant investments and developed a robust organization with strong capabilities in analytical and process development, formulation development, GMP manufacturing, and regulatory filing. The company perceived other opportunities for those capabilities and capacity, particularly at our site in San Diego, California, one of the world's most dynamic biotech hubs. We observed a real need in the CDMO sector that we are well positioned to meet, including our specific expertise in biologics development. This year, in October 2023, we launched our biologics CDMO services here in San Diego, and we are transitioning to be completely dedicated to CDMO clients. We are looking to support customers with a wide range of therapeutic protein programs, such as antibodies. In addition, we can provide a unique, differentiated level of support for biosimilar programs, owing to our deep experience in the associated analytics, demonstration of similarity, and regulatory filings.

DA: To what extent are the challenges that Tanvex faced in advancing the company’s biosimilar pipeline representative of the typical challenges in biosimilar development? How much of a competitive advantage does that give Tanvex BioPharma USA in supporting customers’ biosimilar programs?

JM: The patent dance required to advance a biosimilar, the hurdles one must overcome, the specific analytical regulatory questions, and the data that need to be provided — it's neither a short nor an easy process, and it has elements that differ from the process for a new molecule. It demands specialized expertise, but even more importantly, it demands a high level of tenacity—a quality that truly defines Tanvex. We believe that customers will greatly benefit from both our experience with the drug development process and the tenacity we have developed and refined over the last decade.

Tanvex now holds a product license in Canada, and we anticipate obtaining one in the United States soon. Along the way, there have been times when we've been knocked down, but we consistently get back up and keep pushing forward, inching closer to the finish line. We believe that this quality doesn’t apply solely to biosimilar customers — it will be an asset to any biologics innovator. Whatever a customer's vision may be, we will work together to adopt that vision as our own and invest as much energy and perseverance into it as we have with the Tanvex pipeline programs.

DA: How would you characterize the present moment and the prospects for the near future with regard to the dynamics of the biosimilar market?

JM: Around 15 years ago, when Tanvex BioPharma was founded, there was one biosimilar approved in the EU and almost 10 years after that the first approval in the U.S. Today, we are witnessing multiple biosimilars approvals just in the U.S. per year, and it's an exciting development. With many biologics approaching patent expiration and this trend expected to continue, the opportunities in this field are significant.

However, this opportunity also brings additional challenges. Timing is crucial when it comes to patents. There are various strategies to consider. One approach is to strive to be the first biosimilar for a particular originator product as it comes off patent. Yet, there are also advantages to being the second or third entrant, as there can be savings in terms of experience, learning from others, and even costs if you're not pioneering the path. The strategy may vary depending on the specific market you're targeting. However, there is an optimal window, and it's imperative to deliver within that timeframe. Getting the biosimilar licensed within this window is paramount, or the market share you're aiming for may dissipate. This is another area where the experience and determination of Tanvex can prove critical. We understand the pressure of timing and the importance of landing within that optimal window, and we are well equipped to navigate the complexities of achieving this goal.

DA: Bridging from those key qualities that define Tanvex as an organization, can you tell me about the physical capabilities and capacities underlying the CDMO offering at the San Diego facility?  

JM: The San Diego facility comprises two buildings, offering a total of 100,000 square feet of space dedicated to research and development (R&D), Good Manufacturing Practice (GMP) manufacturing facilities, and quality control (QC) labs. Within this facility, we have two mammalian suites equipped with 1,000-liter reactors, as well as a microbial fermentation suite featuring a stainless-steel tank at a 150-liter scale. We are in the process of scaling up the microbial suite to accommodate a 300-liter disposable tank and expanding our development facilities to support this increased manufacturing capacity. Among the 160 individuals employed at this facility, the majority are involved in development, manufacturing, and quality assurance/quality control (QA/QC) activities.

Our mammalian suite is fully single-use disposable, covering the entire process from vial thaw through drug substance production. It's important to note that we do not currently provide drug product capabilities at this facility. However, we have established partnerships with various drug product fill/finish facilities that we can recommend and collaborate with seamlessly.

Tanvex’s TX01, a biosimilar to Neupogen®, has been approved in both Canada and the United States.

Our commitment to strong analytical capabilities has played a critical role in advancing our biosimilar programs. Our expertise extends to process development, including high-throughput processes, cross-functional teams facilitating efficient parallel development activities, and design-of-experiment work. We prioritize aligning equipment across early development stages and manufacturing and QC to ensure a smooth transfer of processes and methods as programs progress. Additionally, we have significant expertise in high-throughput pre-formulation and drug product formulation development, as well as efficient program and supply chain management capabilities.

DA: Beyond the strong teams that were already in place supporting those key capabilities, have you brought in other key personnel to facilitate the transition into the CDMO space?

JM: Over the last few months, we have focused strongly on building a leadership team, bringing in folks with significant CDMO experience. We just added a vice president of manufacturing with a significant amount of manufacturing, MSAT, and process development experience; a vice president of quality who is a microbiologist by training with significant CDMO, manufacturing, quality and lab experience; a vice president of business development who brings a vast amount of experience in working with numerous different clients, understanding their processes, and helping us align with the needs of our different clients; and a head of program management.

DA: Is the plan to soon open all of the San Diego capacity for your CDMO customers?

JM: Yes, we are all set to serve the biologics clients and make the CDMO business our primary focus.

DA: How strategically important is the location itself to Tanvex CDMO, both in terms of access to the U.S. West Coast biotech community and to Asia?

JM: The location certainly presents many opportunities. There is a high density of biologics organizations on the West Coast, specifically both here in San Diego and in the San Francisco Bay Area. In many cases, the focus is slightly different, primarily on early development and clinical stages. Having our facility here makes us one of the few contract development and GMP manufacturing providers on the West Coast. We bring capacity and capabilities with easy access to these California-based biopharma organizations, not to mention the San Diego airport, connecting us to the APAC region, which is critical given our relationship with the parent Tanvex organization in Taiwan.

While the Tanvex CDMO business is going to be well separated from the broader Tanvex organization, having a sister company based in the APAC region opens a few other doors for us. If we engage with organizations that want to move their products from Asia into the U.S. market, we not only have the capabilities and capacity here but also a foothold in APAC and a strong understanding of Asian markets. Additionally, we share a common language with many Asian organizations. With the work we are already doing to support those Tanvex internal products, we already have the infrastructure and personnel in place for those kinds of interactions. This goes a long way during activities like tech transfer, which are really all about communication, understanding, and agility.

DA: You mentioned that you feel that you are well positioned to support just about any therapeutic protein or antibody program, but is there a certain type of customer organization that you think might have the most to gain from a partnership with Tanvex CDMO?

JM: I believe that we make an excellent partner for any biologics companies working with therapeutic proteins, antibody products, bispecifics, and biosimilar products. Due to our scale, we are particularly well-positioned to assist organizations with a pipeline of products that require early development or early clinical support, such as phase I and phase II programs. With approval in both Canada and the United States, we are clearly better positioned to support customers targeting the North American market. Our organization is ideally suited to collaborate with companies that have a robust pipeline and an immediate need for contract development and manufacturing, as we have the capacity to grow and scale within the organization.

Currently, we have the opportunity to expand within San Diego. We are in the process of adding additional 1,000-liter bioreactors as part of our plan, along with multiple 2,000-liter disposable units. What sets our facility apart is its unique ability to accommodate such scaling without requiring significant renovation or substantial capital funding. In addition to expanding our capacity, we are closely monitoring industry trends. We believe there are significant opportunities in the antibody–drug conjugate (ADC) market that align well with our capabilities. The exceptional analytical capabilities we have already established are analogous to those needed for ADC programs, creating excellent synergy. We have already initiated the expansion of our development capabilities onsite in San Diego to provide these services as well.

DA: Are there any challenges to overcome in establishing this new CDMO identity in the context of the legacy Tanvex brand?

JM: The benefits that we discussed of our association with the broader Tanvex organization can potentially carry some challenges in perception that need to be overcome. Whenever an outsourcing provider also has their own products, some potential customers imagine that, when push comes to shove, the CDMO may prioritize their own products over the customers’. Our answer to that is we have dedicated capacity and resources for the CDMO business. It is important to keep in mind that a CDMO has better visibility to forecast the future needs of their own programs and can plan for the required resources accordingly. Thus, the internal programs of a CDMO ought to be less of an issue than competing client projects.

DA: Before we wrap up, is there anything else that you’d like to share or underline in terms of Tanvex CDMO's personality, culture, or values?

JM: I can answer that from the perspective of someone who has only recently joined the organization. Tanvex CDMO is a tenacious, teamwork-driven organization supported by dedicated scientists who are clear about their objectives and work relentlessly, persevering to get the job done. I think this is demonstrated by their history with their biosimilar programs, which has been a long and challenging process. They've faced different challenges, but they are united as a team by that tenacity. As another example, when I joined, I laid out a four-month window to be ready to launch our CDMO services, which was a significant ask. They stepped up to the challenge to prepare the facility to be externally facing and to work with clients. We're now in the third month, and they've met those tasks each and every time. Tanvex is truly an organization that can pull together, work together, understand its goals and those of its customers, really own the work, and deliver.

As we move forward with working with clients, we want to provide that environment and culture to other biologics organizations to advance their programs. I think that, as we move forward, companies will understand and appreciate the teamwork, the tenacity, the focus, and the deep desire of this unique group of people at Tanvex CDMO to contribute by bringing biologics to market and to patients.

I've been with several CDMOs and other innovators, and I can tell you that, judging by the challenges that I've given them and by working with them over the last few months, I've found that this is truly a unique group. There is something special here in the teams they've assembled, and we are going to carry that forward as we continue to build. It's a real workhorse of an organization.

If you work with Tanvex CDMO, you work with a focused, tenacious team that understands your product and your goals, which is key to a positive client experience. So many clients out there have complaints about their CDMO partners. We really want to be different in terms of the client experience. It really boils down to technical capabilities, astute development to regulatory filing strategy, communication, and partnership, and we are keeping that top of mind in everything we do, now and into the future.

John R. Mosack

John Mosack is the Chief Operating Officer (COO) at Tanvex, bringing over 30 years of operations management experience in the biopharmaceutical industry for both drug substance and drug product facilities. Prior to joining Tanvex, he held pivotal roles at Catalent Biologics, Lonza, Inc., Bristol-Myers Squibb, and PAREXEL. His extensive expertise spans various biologic modalities (antibodies, cell, and gene therapy) as well as technology platforms (mammalian, microbial fermentation). John has led organizations successfully through state-of-the-art facility start- ups, drug development lifecycle transitions (clinical to commercial), multiple product licensures, operational efficiencies, and technology transitions. John believes a key to success is cultivating a focused, collaborative, and diverse team aligned with the strategic plan of an organization.