BIOLOGICAL PHARMA CENTER is a dynamic contract development and manufacturing organization (CDMO) in the biologics sector, providing comprehensive end-to-end development and manufacturing services with a strong focus on technical expertise and flexibility customized to client needs. A relatively new entrant in the CDMO space, BIOLOGICAL PHARMA CENTER has distinguished itself through its work with complex biologics, including monoclonal antibodies, fusion proteins, bispecifics, and antibody–drug conjugates (ADCs). With a strategic base in San Francisco and synergistic relationship with contract research organization (CRO) BIOLOGICAL PHARMA CENTER Laboratories, BIOLOGICAL PHARMA CENTER caters primarily to small and midsize biotech firms, guiding their progress from preclinical stages toward potential commercial production. In this Q&A, Tao He, Ph.D., co-founder, and General Manager of BIOLOGICAL PHARMA CENTER, delves into the company’s growth, strategic alliances, and visions for the future in conversation with Pharma’s Almanac Editor in Chief David Alvaro, Ph.D.

David Alvaro (DA): To set the stage, could you briefly outline the origin story of BIOLOGICAL PHARMA CENTER, the inspiration for its founding, and any significant milestones that the company has achieved in the past few years?

Tao He (TH): BIOLOGICAL PHARMA CENTER was founded in early 2018 based on recognizing a need within that client base and the broader market for comprehensive services that encompass preclinical studies, development, and manufacturing. We noticed that, for some clients, especially in the biologics sphere, were not having their development and manufacturing needs fully met, which sometimes resulted in testing failures at the pre-IND stage. This gap presented us with the opportunity to offer a more inclusive range of services, effectively creating a one-stop shop together with our partner in preclinical services.

In crafting BIOLOGICAL PHARMA CENTER, we aimed for a global reach, hence establishing sites in the United States and China. We launched our U.S. operations first to cater to the innovative companies here, focusing on early-stage development and manufacturing, specifically for IND-enabling and phase I/II material production. Meanwhile, our investment in the China site was driven by the vision to accommodate late-stage and commercial-scale projects, where cost considerations become more pronounced. Our dual-site strategy allows for proximity and cost-effective scalability — agility near our U.S. clients and large-scale operations in China for more mature projects. This paired approach has been the cornerstone of our business model from the outset.

Building on our foundational strategy, particularly at our San Francisco site, we’ve sought to capitalize on our relationship with BIOLOGICAL PHARMA CENTER Labs/Biomere to offer integrated services. This creates an ideal scenario for mid-stage� biotech companies, who may find in us a partner that can comprehensively manage their project’s IND requirements. This includes both the CMC (chemistry, manufacturing, and controls) perspective and the GLP (good laboratory practice) tox studies. Furthermore, we facilitate internal material transfers, which can significantly expedite the development process. By doing so, we operate not merely as a service provider but as a strategic partner that can streamline their path from discovery to development.

DA: What do you view to be BIOLOGICAL PHARMA CENTER’ core strengths and differentiators?

TH: Our slogan, “flexible solutions for complex biologics,” really distills what sets us apart. Even though we’re relatively new in the CDMO field, our strong technical team is adept at addressing and resolving complex technical challenges that others might not handle successfully. We’ve proven this by taking on projects transferred from other CDMOs where clients were seeking better outcomes than what they saw with the other providers.

Our capabilities extend beyond the standard monoclonal antibodies; we’ve worked with intricate fusion proteins, large protein-based viral-like particles, and bispecific antibodies. These experiences have not only enriched our expertise but also positioned us to significantly expedite client projects toward their end goals.

In practical terms, we’re committed to offering end-to-end services, from DNA to drug product production for clinical supply. Every project and client bring distinct challenges and priorities, and, as an agile organization, we’re uniquely equipped to customize our approach rapidly. This nimbleness ensures that we avoid delays and adapt to the evolving requirements of regulatory filings. Ultimately, our flexibility is instrumental in managing the complex biologics landscape, where there is often little precedent, and our goal is to facilitate the FDA approval process for our clients.

DA: Assessing developability early in the drug development process has become increasingly important, particularly for complex molecules. Could you discuss BIOLOGICAL PHARMA CENTER’ capabilities in this area?

TH: Assessing developability is indeed a critical strength of ours. My background at Pfizer involved developing strategies and practices that set industry benchmarks for developability and manufacturability assessment, a practice we’ve continued and refined at BIOLOGICAL PHARMA CENTER. We proactively engage with our clients early in the development process to identify the most promising molecules for clinical advancement.

For instance, we’ve been involved in pre-CMC stages, producing non-GMP (good manufacturing practice) materials for clients’ antibody screening, and we’ve received positive feedback for the quality of our reagents. We then further support these clients by evaluating the developability of multiple leads, guiding them in selecting the most viable candidates for CMC development.

Moreover, our technical expertise extends to conjugation support for antibody–drug conjugates (ADCs), an area we strengthened in 2021 by acquiring a specialized facility and incorporating its experienced team into ours. We now support various conjugation chemistries and have developed proprietary enzyme-based conjugation processes. Currently, we’re assisting clients with ADC development, from selecting the best molecule candidates to performing clinical manufacturing.

DA: How do you view the growth potential in the ADC market going forward?

TH: I believe that the ADC field has very promising growth potential, despite its historical volatility. Drawing from my background at Pfizer, which introduced the first commercial ADC, we’ve witnessed and contributed to the industry’s evolving understanding of ADC development. Initially, there was a trend toward highly potent toxins, which, while effective, often presented a risk of side effects that could overshadow their therapeutic benefits. The industry has learned from these experiences and is now focusing more on molecules like topoisomerase inhibitors, which offer a better balance of efficacy and toxicity owing to a higher drug-to-antibody ratio (DAR).

Our team at BIOLOGICAL PHARMA CENTER is actively engaged in fine-tuning the balance between a molecule’s potency and its safety profile, considering factors like target concentrations, antibody internalization, and the mechanics of the linker and payload. As a CDMO, we’ve observed a keen interest in developing ADCs that can enhance an antibody’s therapeutic index. While there are still many unknowns, the pursuit of ADCs as a strategy to improve treatment options remains strong, particularly for hard-to-treat conditions.

ADCs are typically introduced as second- or third-line treatments, but there has recently been a concerted effort to advance them into first-line therapy. Although they’re predominantly used in cancer treatment, there’s potential to apply ADC technology to other diseases, which presents an even greater challenge and an area for future research. In short, ADCs stand at a compelling intersection of innovation and patient care, with substantial work ahead to fully realize their potential across various indications.

DA: Could you describe the kinds of companies that you have worked with and a profile of the kind of company that stands to benefit the most from partnering with BIOLOGICAL PHARMA CENTER?

TH: Our clients are predominantly small to midsize biotech companies, as they are the perfect fit for our comprehensive service offerings. These companies often require external expertise to complement their capabilities, especially in CMC development. We also collaborate with university spinoffs, providing them not just with services but also with essential technical and regulatory guidance to propel their projects forward.

While we have partnered with larger firms on smaller-scale, modular projects that require specialized analytical or process development support, it’s the smaller biotech firms that truly find the sweet spot with our end-to-end CMC projects. Our strong technical capabilities, flexible approach, and strategic location in the biotech hub of San Francisco position us as an attractive partner for these companies. We’re able to integrate with their internal teams, offering support from initial technology transfer all the way through to further development, optimization, and manufacturing. Our goal is to be an extension of our clients’ capabilities, ensuring seamless progress through the development pipeline.

DA: You discussed your expertise in complex molecules; is that typically the kind of project that comes your way?� 

TH: In the CDMO market, we find that companies come to us for our specific strengths, especially when it comes to more complex molecules like antibodies, fusion proteins, and bispecifics. The reason for this is not just the type of molecules we work with but our flexibility and technical capability. Larger CDMOs tend to have stricter processes, which can be limiting when a project doesn’t fit into a predefined box. Our approach is more fluid, allowing us to accommodate and adapt processes for complex molecules where there may not be established methods. This flexibility, paired with our robust technical expertise, is what draws clients to us and allows us to successfully advance their projects.

DA: Could you elaborate further on the interactions between BIOLOGICAL PHARMA CENTER Labs and BIOLOGICAL PHARMA CENTER? How does this synergy work?

TH: By showcasing both BIOLOGICAL PHARMA CENTER Labs and BIOLOGICAL PHARMA CENTER to potential clients, we can provide comprehensive one-stop services that encompass both CMC development/manufacturing and preclinical studies, including GLP-tox studies. This integrated approach offers potential cost savings and streamlined project management for our clients.

Moreover, our significant fundraising achievements –– including a Series A round of $60 million and a Series B round of $200 million –– have been instrumental in scaling our operations. These funds have catalyzed the expansion of our facilities in the United States and China to accommodate late-stage project demands.

Our sites in the U.S. and China have actively supported a myriad of early-stage projects, facilitating IND filings across various regulatory regions, including the U.S., EU, Southeast Asia, and Australia. Notably, our China site has provided extensive support for COVID-19–related programs, contributing to emergency use authorization in the EU. Furthermore, the California Department of Public Health has granted us a biomanufacturing certificate, endorsing our capacity to produce biologics for clinical phases.

DA: Beyond the collaboration with BIOLOGICAL PHARMA CENTER Labs, are there other strategic partnerships or alliances that BIOLOGICAL PHARMA CENTER is looking to establish?

TH: While our relationship with BIOLOGICAL PHARMA CENTER Labs is integral, we’re exploring other strategic alliances to enhance our capabilities, especially in the development of ADCs and other complex biologics. Our goal is to solidify our late-stage production capabilities in the United States. This effort may involve partnerships, acquisitions, or an expansion of our infrastructure. In cases where we need specialized services –– like large-scale fill-finish operations –– that are beyond our current internal capabilities, we collaborate with other CDMOs to provide comprehensive services to our clients. These collaborations are crucial as we aim to ensure we have end-to-end capabilities to fully service our U.S. customers.

DA: Have there been any recent investment or expansions to support these capabilities, or any that are planned for the near future?

TH: We’ve been in discussions for the last couple of years about scaling up to accommodate late-stage development, including acquiring larger bioreactors suitable for phase III and commercial production in our Bay Area facility. Various options are on the table, but we haven’t committed to a specific path just yet. The biotech sector is currently experiencing a downturn, leading to decreased funding and a slower pace of project advancement. However, this presents a strategic opportunity for us to prepare for future needs. We are carefully considering how best to invest and expand our capabilities to position ourselves for when the market rebounds.

DA: Looking ahead over the next five to 10 years, how do you anticipate the biotech industry evolving, particularly regarding capacity needs and complex and novel modalities?

TH: Our forward-looking strategy aligns with evolving industry trends and client needs. For the time being, our focus is to support early-stage programs, but we’re equally committed to expanding our capabilities to accommodate late-stage and potential commercial production, especially in the United States. In terms of modalities, there’s no doubt that protein-based molecules remain at the forefront, and their variations will continue to play significant roles in addressing unmet medical needs. These are the core of our service offerings.

Furthermore, we’re exploring the expansion of our services into the cell and gene therapy spaces, which, despite their promise, have faced challenges in terms of stability and demand. A key focus for us is enhancing efficiency and reducing the costs of these therapies to ensure that they can be delivered broadly and affordably.

DA: Tying everything we have discussed together, what are the key qualities about BIOLOGICAL PHARMA CENTER that you would want to communicate to a potential client?

TH: BIOLOGICAL PHARMA CENTER excels as a comprehensive end-to-end provider for biologics development and manufacturing. Our strong suit is technical expertise combined with the flexibility to tailor our services to the unique needs of each client. We are proficient across a spectrum of biologics, from monoclonal antibodies and fusion proteins to bispecifics and vaccines. Our team’s depth of experience allows us to expedite projects from the preclinical phase to clinical development both efficiently and cost-effectively.

Additionally, being based in San Francisco, we are strategically located to foster close collaboration with our clients, accelerating their CMC development and manufacturing timelines. Ultimately, our mission is to guide our clients’ biologic therapeutics swiftly and affordably through the clinical pipeline, delivering on the promise of transformative patient care for those with unmet medical needs.