WCC BIOMEDICAL Overcomes Microneedle Array Patches Manufacturing Challenges, Advancing Next-Generation Drug Delivery

The biomedical industry continues to explore innovative drug delivery approaches to overcome the limitations of conventional administration methods. Among these emerging technologies, microneedle patches (MNPs), also known as Microneedle Array Patches (MAPs), have attracted global attention for their potential to transform drug delivery. However, translating MAP technology from laboratory research into commercial applications remains challenging. The industry still faces three major hurdles: adequate loading, accurate dosing, and automatic mass production (3A).

During BIO Asia–Taiwan 2026, GeneOnline spoke with Dr. Ta-Jo Liu, Founder and Chairman of WCC BIOMEDICAL (WCC), to discuss how the Taiwan-based biotechnology company is advancing microneedle patch commercialization through its proprietary WINMAP™ technology platform. As one of the few companies worldwide to approach microneedle patch technology into the PIC/S GMP pilot production stage, WCC is addressing key manufacturing bottlenecks through automated production capabilities and platform innovation. In this exclusive interview, Dr. Liu shares the company’s vision for accelerating global adoption of microneedle patches, expanding into CDMO opportunities, and preparing for Taiwan’s capital market in 2027.

MAPs Break Traditional Drug Delivery Barriers Across Healthcare Applications

Dr. Liu explained that the Microarray Patch (MAP), commonly known as Microneedle Array Patch, is a novel transdermal drug delivery system (TDDS) that uses micron-scale needles to penetrate the skin’s stratum corneum and deliver active ingredients directly into skin tissue. The term MAP has become increasingly adopted by researchers to describe patches composed of densely arranged microscopic needles arranged in an array structure.

Compared with conventional injections, MAP technology offers several advantages, including painless administration, greater convenience, and improved patient compliance. Because the microneedles penetrate only the superficial layers of the skin, they avoid deeper nerve endings and significantly reduce discomfort. At the same time, MAPs overcome the skin’s natural barrier, enabling the transdermal delivery of large molecules, such as proteins and peptides and mRNAs, that are traditionally difficult to deliver through the skin.

MAP technology has been under development since 1998, with research and development advancing steadily for nearly three decades. Applications have expanded across medical aesthetics, skincare, pharmaceuticals, vaccines, and biosensing. Among these fields, cosmetic products have already reached commercialization, while vaccines, biologics, and therapeutic products continue progressing through clinical development toward broader market adoption.

In 2020, the World Economic Forum recognized MAP technology as the leading emerging technology with the potential to positively transform society in the coming years. MAP technology, one of the most advanced applications of microneedle systems, was also ranked the top priority vaccine delivery technology in a VIPS (WHO, Gates, Gavi, PATH, UNICEF) research evaluation, demonstrating growing global confidence in the field and the companies driving its development.

Enabling High-Potency Drug and Vaccine Delivery

Dr. Liu noted that microneedle patches represent a promising approach for reducing side effects and improving bioavailability. Although each microneedle patch carries a lower drug volume compared with conventional drug delivery options, this feature can help avoid side effects or first-pass effect. Meanwhile, by bypassing the stratum corneum barrier, making MAP particularly suitable for high-potency, low-dose therapeutics.

Currently, approximately 20 types of drugs have been explored for integration with microneedle patch technology, including insulin, glucagon-like peptide-1 receptor agonists, analgesics, and chemotherapy-induced nausea and vomiting treatments. Dr. Liu added that, as of 2026, numerous animal studies have demonstrated favorable drug activity and pharmacokinetic profiles for microneedle patches. However, human clinical data remain relatively limited.

He also highlighted WCC’s previous collaboration with the National Health Research Institutes in Taiwan to develop a microneedle patch-based enterovirus 71 vaccine, supported by a Small Business Innovation Research (SBIR) grant from Taiwan’s Ministry of Economic Affairs. Dr. Liu emphasized that vaccines represent another major application area for microneedle patches.

In the event of future large-scale infectious disease outbreaks, microneedle patches could potentially enable mail-based distribution due to its enhanced stability, allowing individuals to complete vaccination without visiting healthcare facilities. This approach could reduce pressure on healthcare systems, lower the risk of cross-infection, and improve vaccination willingness. The technology may also reduce antigen requirements to only 10–20% of conventional injection levels while providing almost the same immunogenicity and painless injection. 

He also revealed that the company is currently developing a microneedle patch platform for mRNA vaccines in combination with lipid nanoparticle (LNP) technology. The platform has already achieved approximately 70% activity retention, with the team continuing to optimize the technology toward the ideal range of above 90% activity preservation.

The Three Challenges of MAP Commercialization

“To date, no pharmaceutical or vaccine MAP product has received FDA approval and successfully reached commercialization,” said Dr. Liu. He believes that overcoming the gap between laboratory development and large-scale manufacturing remains the industry’s biggest challenge.

Liu noted that the FDA began issuing requirements for microneedle products as early as 2017, with uniformity being a key focus. Uniformity among needles, patches, and batches, while drug loading and release profiles must also remain consistent. Companies must demonstrate this uniformity through all preclinical and clinical studies.

“Achieving uniformity in the lab is not difficult—you can make a few patches a day and maintain consistency. The real challenge is scaling up,” Dr. Liu noted. “When production reaches 10,000 or even 100,000 patches per day, ensuring every microneedle demonstrates the same quality becomes the industry’s biggest bottleneck.”

He summarized the current technical bottlenecks into three key areas: sufficient dose, precise dosing, and scalable manufacturing. First, dose sufficiency remains a critical challenge. Although microneedles carry smaller drug quantities, their higher absorption efficiency requires careful calculation to ensure that patients receive therapeutically effective doses.

The second challenge is dosing precision. Manufacturers must ensure consistent microneedle dimensions while accurately controlling both the drug amount contained in each patch and the actual dose delivered into the body. The final challenge is scalable manufacturing. Producing microneedle patches involves complex processes, including material selection, microstructure fabrication, drug loading, and quality control. Establishing stable large-scale manufacturing capabilities that comply with GMP standards remains a major hurdle for the industry.

As a result, advancing pharmaceutical microneedle products requires collaboration beyond traditional pharmaceutical companies. Companies with expertise in materials science, precision manufacturing, and drug delivery technologies have become important drivers of innovation in this field.

For example, Micron Biomedical has actively developed microneedle vaccine platforms using dissolvable microneedle patch technology to create new delivery approaches for vaccines and biologics. The company aims to enable more convenient, painless vaccination and self-administration models.

Meanwhile, Australian microneedle vaccine developer Vaxxas has developed the High-Density Microarray Patch (HD-MAP), which leverages the abundance of immune cells in the skin’s upper layers to enhance vaccine antigen presentation efficiency. The company has also advanced multiple vaccine candidates into clinical studies.

How WINMAP™ Facilitates MAPs Commercialization

Reflecting on his entry into the microneedle field, Dr. Liu said it was somewhat coincidental. In 2009, while teaching at National Tsing Hua University, he was approached by a company that saw the potential of microneedles in aesthetics and asked him to develop a mass production line. This project marked his entry into the field. 

After founding WCC in 2018, his first major order was to build a microneedle manufacturing line for the same partner, which was completed in 2022. The experience convinced him that microneedles should not be limited to aesthetics, but could also create greater impact in healthcare and vaccines, leading him to extend his manufacturing expertise into medical applications. These efforts ultimately laid the foundation for the development of its proprietary WINMAP™ platform. 

WINMAP™, a comprehensive Microarray Patch (MAP) platform encompassing four key capabilities: PD²F (Penetration、Dissolution、Diffusion，Function), M²DB (Microneedle Material Database, MMDB, Microneedle Formulation Database, MFDB), PLC (Precision Loading & Coating), and AMASS (Automatic Mass Production). Together, these technologies address critical aspects of MAP commercialization, including formulation development, drug delivery optimization, and scalable manufacturing.

Among these technologies, PD²F enables it to optimize drug delivery performance by evaluating key parameters of microneedles, including penetration, dissolution, diffusion, and the functionality of incorporated active pharmaceutical ingredients (APIs). Meanwhile, M²DB, comprising in-house developed material and formulation databases, enables efficient material screening and formulation optimization while supporting the development of MAPs that meet regulatory standards.

On the manufacturing side, WCC has developed Precision Loading & Coating (PLC) technology, an advanced MAP fabrication approach derived from micromolding, to ensure consistent and precise drug loading. The company has also established a fully proprietary Automatic Mass Production (AMASS) system, enabling high-yield, large-scale manufacturing that meets international GMP requirements. The platform achieves less than 3% variation in drug loading between batches, less than 3% geometric variation, targeting an annual production capacity of 10 million per line capacity of 10 million MAPs, and a yield exceeding 95%.

It has also developed the patented WINMAP™ mini platform, focusing on accelerated development and point-of-care preparation applications. Dr. Liu explained that conventional MAP development often requires months of formulation development, process establishment, and product preparation. In contrast, WINMAP™ mini enables rapid and precise coating of active pharmaceutical ingredients (APIs) onto pre-manufactured Hydrogel Microarray Patches (H-MAPs). After packaging, the product is ready for use, potentially reducing preparation timelines from three months to only a few hours while significantly improving development efficiency and product flexibility.

Dr. Liu noted that WINMAP™ mini can serve as a MAP development workstation, allowing researchers to rapidly evaluate different formulations and product designs while shortening development cycles. For future clinical scenes, the platform could support personalized medicine approaches and enable future deployment in remote regions, offshore islands, and areas with limited healthcare resources.

WCC-301: A MAP-Based Novel Pain Therapy in Development

Discussing WCC’s flagship product, WCC-301, a 505(b)(2) novel analgesic drug for acute ankle sprain, Dr. Liu explained that pain management represents a broad and recurring therapeutic area. Compared with rare cancers or orphan diseases, pain-related indications have greater public accessibility, making WCC-301 an ideal first product to demonstrate the feasibility of WINMAP™ to patients, regulators, and the biotechnology industry.

In a single-dose pharmacokinetic study in minipigs, WCC-301 reached peak plasma concentration within 15 minutes across all groups, with exposure (AUC) increasing dose-proportionally and absolute bioavailability of 35–43%. highlighting improved transdermal absorption compared with conventional topical patches.

WCC-301 is being developed under the U.S. FDA’s 505(b)(2) New Drug Application (NDA) pathway. Following completion of an FDA Pre-IND consultation, WCC plans to submit an IND application to FDA in the United States in Q3 2026, followed by a subsequent submission to TFDA in Taiwan.

Partnering with Global Transdermal Leader to Advance MAP CDMO

For its global expansion strategy, WCC is currently exploring a strategic partnership with a leading global transdermal leader manufacturer. The collaboration aims to combine the partner’s global market access, regulatory expertise, and brand strength with WCC’s WINMAP™ platform to accelerate international commercialization.

The two companies have signed a Material Transfer Agreement (MTA), under which the global partner independently reproduced key experimental results from WCC-301, further validating the technical feasibility of the WINMAP™ platform.

Future collaboration opportunities will focus on Microarray Patch (MAP) CDMO services, including the potential introduction of the partner’s novel dosage forms into WCC’s manufacturing facility. The companies may also explore licensing or co-development opportunities for the WCC-301 analgesic MAP product. 

Expanding MAP Applications into Consumer Health

Dr. Liu also introduced GeneOnline to WCC’s Bumblebee series of cosmetic microneedle products showcased at BIO Asia–Taiwan 2026.

The Bumblebee Power Patch, the company’s flagship men’s skin vitality product, combines innovative formulations featuring black maca root extract and L-arginine. Leveraging MAP technology, the patch delivers active ingredients through the skin while bypassing limitations associated with stratum corium, boosting skin vitality for men.

The Bumblebee V Patch, a firming skin beauty solution, targets the emerging “tech neck” concern among smartphone users. As an OTC daily beauty patch, it features a dual-action formulation combining hibiscus extract for antioxidant benefits and capsaicin to support local microcirculation.

Building Taiwan’s Next Biotech Success Story

“Taiwan cannot surpass global pharmaceutical giants by simply following the path they have already taken,” said Dr. Liu.

In his view, Taiwan’s true advantage lies not in competing with global pharma companies on drug discovery scale, but in integrating its world-class engineering capabilities, including semiconductors, precision manufacturing, automation, and AI with medical innovation. Microneedles exemplify this strength, requiring not only exceptional manufacturing precision but also advanced scale-up and engineering integration, areas where Taiwan excels. This opportunity has also attracted increasing interest from electronics and precision manufacturing companies seeking to enter the biotech sector. Dr. Liu revealed that several major Taiwanese semiconductor and optoelectronics companies have recently approached WCC for potential collaborations.

Therefore, WCC is taking a stepwise approach, starting with new formulations of existing analgesics to establish commercialization and manufacturing capabilities before expanding into broader, high-value medical applications. For Dr. Liu, the mission has remained unchanged: leveraging the integration of engineering and medicine to build a globally competitive microneedle platform and help create Taiwan’s next success story in biotechnology.

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