EirGenix Showcases End-to-End Biologics Platform at BIO Asia–Taiwan, Highlighting CDMO Growth

At BIO Asia–Taiwan 2026, EirGenix (TWSE: 6589) showcased its end-to-end biologics development and manufacturing capabilities through its exhibition booth and Mini Talks series, highlighting key aspects across the biologics value chain — from plasmid DNA (pDNA) manufacturing and bioanalytical technologies to expression system selection and antibody-drug conjugate (ADC) development strategies.

Developing a successful biologic requires far more than discovering a promising molecule. The company demonstrated how its integrated platforms, technical expertise, and extensive biologics development experience can help partners mitigate risks, improve development efficiency, and accelerate the path toward commercialization.

In an exclusive interview with GeneOnline, Lee-Cheng Liu, Founder, Chairman of EirGenix, emphasized that as biologics continue to advance rapidly, success depends not only on innovative therapeutic mechanisms but also on the underlying capabilities that enable products to progress through clinical development and achieve commercial success.

“Even as emerging modalities such as ADCs and bispecific antibodies (BsAbs) attract increasing investment and industry attention, a promising molecule alone is not enough,” Liu said. “Without robust development platforms, analytical capabilities, and well-established CMC (chemistry, manufacturing, and controls) strategies, even the most promising candidates may struggle to reach commercialization.”

EirGenix’s Dual Growth Drivers: CDMO and Biosimilars

During the exhibition, Vice President Hsiao Bi-khim also visited the EirGenix booth to learn more about the company’s achievements in biologics CDMO and commercial manufacturing. EirGenix highlighted its capabilities in developing and manufacturing biologics in compliance with international regulatory standards, supporting global partners with reliable commercial-scale production and demonstrating how Taiwan’s manufacturing expertise can serve global markets. Through these efforts, the company aims to strengthen global pharmaceutical supply chain resilience by providing stable and dependable manufacturing capacity.

EirGenix’s biosimilar EIRGASUN® has recently received expanded reimbursement approval from Taiwan’s National Health Insurance Administration. This milestone not only reflects the continued advancement of Taiwan’s biotechnology industry, but also improves treatment accessibility for cancer patients, bringing high-quality biologic medicines to more people. This also demonstrates Taiwan’s biotechnology industry’s dual-track growth strategy—combining proprietary product commercialization with global CDMO services.

Addressing the rapid transformation driven by artificial intelligence (AI), EirGenix noted that AI is accelerating advancements in biologics development and process optimization. However, from scientific decision-making and process development to quality management and commercial manufacturing, successful implementation still relies on the expertise of professionals and cross-disciplinary collaboration to ensure the quality, safety, and consistent supply of biologic medicines.

Scaling Microbial Manufacturing for Global CDMO Growth

EirGenix’s new microbial manufacturing facility in Zhubei is scheduled to officially begin operations on September 16, with the market closely watching how the expansion will impact the company’s future operations and product portfolio strategy. Liu said the facility’s primary mission is to expand EirGenix’s manufacturing capacity for microbial expression-based protein production and further strengthen its CDMO competitiveness.

“Global demand for microbial expression-based protein production continues to grow, while overall manufacturing capacity remains insufficient,” Liu argued. “We believe the new facility will enable EirGenix to undertake more CDMO projects in the future.”

Beyond broader market demand, increasing capacity requirements from existing customers are also a key driver behind the facility expansion. Liu explained that some customers’ products are currently manufactured at EirGenix’s Xizhi facility, where existing production lines are already approaching full capacity. As customers anticipate continued market growth, EirGenix decided to establish the Zhubei microbial manufacturing facility to support future capacity needs.

These market dynamics and customer expansion plans were key considerations behind EirGenix’s decision to expand its microbial manufacturing capacity.

Compared with the approximately 150-liter capacity currently available at the Xizhi facility, the Zhubei facility will add approximately 1,500 liters of production capacity. Liu believes that the larger manufacturing scale will help EirGenix pursue larger CDMO opportunities and further enhance its competitiveness in the global biologics manufacturing market.

EGpLX™ Platform Advances Plasmid DNA Manufacturing

Turning to plasmid DNA manufacturing, Liu noted that misconceptions remain within the industry regarding the complexity of the process. Some assume that selecting a commonly used E. coli strain is sufficient to begin plasmid DNA production. However, the reality is far more complex.

The heterologous DNA carried by different plasmids can interact differently with host strains, meaning that no single strain is universally suitable for all products. Some strains may offer faster growth but limited productivity, while others may achieve higher yields but compromise product quality. Selecting an unsuitable host strain at an early stage can create significant challenges during process scale-up, resulting in additional time and cost.

Therefore, identifying the optimal host strain and production conditions before scale-up is critical. Liu highlighted EirGenix’s EGpLX™ platform as an example of how the company addresses this challenge. By establishing a multi-strain screening platform, the company enables rapid comparison of host strains based on growth characteristics, plasmid DNA yield, and quality attributes before the manufacturing process is established. This allows optimal production conditions to be identified early, rather than requiring costly adjustments after process development.

The platform has achieved plasmid DNA yields of approximately 1.2 g/L while maintaining more than 90% supercoiled DNA content. For advanced therapies such as gene therapies, cell therapies, and nucleic acid-based medicines, which require large quantities of high-quality plasmid DNA, manufacturing platforms that integrate productivity, quality, scalability, and reproducibility are becoming increasingly valuable.

Precision Analytics and Expression Systems Shape Biologics Development

Completing the manufacturing process is only the first step. The next challenge is generating reliable analytical data to demonstrate that a biologic meets quality, functional, consistency, and regulatory requirements throughout development.

To address this challenge, EirGenix highlighted its precision bioanalytical capabilities during its Mini Talk sessions, integrating technologies including enzyme-linked immunosorbent assay (ELISA), surface plasmon resonance (SPR), and cell-based bioassays to help development teams establish comprehensive product characterization profiles.

ELISA enables quantitative measurement of proteins and other biomolecules; SPR evaluates antibody–target interactions, including binding capability, affinity, and binding kinetics; while cell-based bioassays further verify whether a product demonstrates the expected biological activity. Together, these analytical approaches support product development, quality control, and regulatory submissions, while providing reliable scientific insights for process optimization and subsequent technical decision-making.

During the exhibition, EirGenix also explored how different biologics should be matched with appropriate expression systems through a session titled “Microbial vs. Mammalian.” Microbial platforms offer advantages including shorter production cycles, lower manufacturing costs, and scalability, making them well suited for products such as recombinant proteins, enzymes, and plasmid DNA.

In contrast, mammalian cell systems provide more human-like post-translational modifications, including the ability to perform complex glycosylation, making them particularly suitable for complex biologics such as monoclonal antibodies, bispecific antibodies, and antibody-drug conjugates.

However, Liu emphasized that choosing between microbial and mammalian expression systems is not a matter of superiority, but rather a strategic decision based on molecular characteristics, product requirements, and long-term CMC planning. Viewed together, EirGenix’s Mini Talks series highlighted a common theme: reducing uncertainty throughout the biologics development journey.

Emerging Therapies, AI, and CDMO to Drive the Next Wave of Biotech Growth

Beyond his perspective as a biotech executive observing the evolution of biologics development and technology, he also serves as Chairman of the Taiwan Bio Industry Organization, sees global biotech entering a new phase of growth driven by three key forces: advanced therapies, AI, and CDMO capabilities.

“This year, BIO Asia–Taiwan 2026 welcomed exhibitors from 22 countries and participants from around 50 countries, while facilitating more than 10,000 business matchmaking opportunities,” Liu said. He noted that these figures not only reflect the growing international influence of BIO Asia–Taiwan, but also demonstrate increasing demand across the biotech sector for cross-border collaboration and integrated supply chains.

Liu believes regenerative medicine and cell therapy will become major growth drivers for the biotechnology industry. At this year’s conference, Japanese experts Keiichi Fukuda and Yoshiki Sawa shared clinical research advances in generating cardiomyocytes from induced pluripotent stem cells (iPS cells). Liu said he hopes these emerging technologies can eventually be translated into clinical development opportunities in Taiwan, fostering greater industry collaboration and innovation.

Beyond advanced therapies, Liu noted that AI has moved beyond conceptual discussions and is increasingly becoming embedded in real-world biotech applications. However, he emphasized that the foundation of successful AI adoption lies in high-quality data.

For this reason, EirGenix has been actively advancing process digitalization, building manufacturing data infrastructure, and moving toward smart manufacturing. “Future biomanufacturing will not simply be about implementing AI,” Liu highlighted. “It will require integration with digital tools such as process analytical technology (PAT) and electronic batch records (eBR) to establish more real-time and precise manufacturing management systems. The most important step is building your own data foundation — only then can AI truly deliver value.”

Liu also highlighted CDMO as another area where Taiwan holds significant potential. As global pharmaceutical companies increasingly outsource manufacturing to specialized partners and focus their resources on drug discovery and development, CDMOs with strong manufacturing capabilities are positioned to capture new growth opportunities.

To strengthen Taiwan’s visibility in the global biomanufacturing ecosystem, the Taiwan CDMO Alliance (TCA) has continued expanding international outreach through overseas roadshows, including initiatives in the United States, to showcase Taiwan’s biologics manufacturing capabilities to global pharmaceutical companies.

“We want the world to recognize that Taiwan is not only home to semiconductor excellence, but also possesses internationally competitive biotechnology manufacturing capabilities,” Liu noted.

Building Taiwan’s Value-Driven CDMO Future

As global pharmaceutical companies place increasing emphasis on supply chain resilience, Taiwan’s biologics, CDMO, and biosimilars sectors are receiving growing attention from international partners. However, Liu believes that for many Taiwanese companies expanding into global markets, the greatest challenge is no longer technical capability or product quality, but the uncertainty arising from geopolitical risks.

Liu noted that cross-strait dynamics have increasingly become an important factor considered by global pharmaceutical companies when evaluating supply chain risks. During partnership discussions, Taiwanese companies may therefore be required to provide additional contingency plans and risk management strategies. These measures not only increase operational costs but may also affect flexibility in commercial negotiations.

“We do not want to become a bargaining chip amid competition among major powers,” Liu said. He emphasized that maintaining a stable and open environment for international collaboration will be critical for Taiwan’s biotechnology industry as it expands into global markets.

Nevertheless, Liu stressed that Taiwan possesses significant advantages in biomanufacturing, including decades of manufacturing expertise, a strong quality management culture, and a foundation of trust built through its engineering talent and broader industrial ecosystem.

Drawing on EirGenix’s collaborations with international partners such as Sandoz, Liu noted that global pharmaceutical companies have increasingly recognized Taiwan’s capabilities in quality and R&D. In some areas, Taiwanese teams have demonstrated innovation and development capabilities that meet international standards.

“The future competitiveness of Taiwan’s CDMO industry cannot rely solely on providing manufacturing services. Simply offering manufacturing capacity alone will be difficult to sustain in the long term. The key is to continuously enhance value creation and ask how we can deliver greater value to our partners. This will determine whether Taiwan can differentiate itself in the global biomanufacturing supply chain,” Liu concluded.

Author

Steven Chung

紅杏枝頭春意鬧固然是眾人所追求的風景，但我願意說，青蘿拂行衣更能湧生感嘆。 願在海量晦澀的生醫資訊中，為您點亮一座心燈塔。鐘煌翔