[Edaily Reporter NA EUN-KYUNG ] Inventage Lab Inc.(389470)has begun technical validation of its next-generation subcutaneous (SC) formulation modification platform, “IVL-BioFluidic™.” The company has signed material transfer agreements (MTAs) with several domestic firms and is now receiving antibody bulk solutions from partner companies to verify target concentrations and stability, marking the stage where the technology is being applied to antibodies from actual pharmaceutical and biotech companies.

Kim Ju-hee, CEO of Inventage Lab Inc., met with E-Daily at the company’s headquarters in Seongnam, Gyeonggi Province, on the 1st and stated, “Many of the MTAs signed recently are related to IVL-BioFluidic,” adding, “We are currently receiving actual development materials from partner companies and verifying whether IVL-BioFluidic can be applied to each antibody.”

Validating Actual Compounds Through MTAs… Expanding Overseas Partnerships

Unlike a Memorandum of Understanding (MOU), which introduces technology or confirms intent to collaborate, an MTA is a contract under which a pharmaceutical company provides candidate compounds currently under development to an external party. While an MTA does not necessarily lead to a technology export agreement, it is viewed as the starting point for commercialization, as it demonstrates a partner’s willingness to apply the technology to actual candidate compounds—especially given that the company must transfer high-cost antibody bulk solution and related development information to an external firm.

Inventage Lab Inc. is currently conducting initial suitability evaluations to identify particle manufacturing conditions and formulations tailored to the characteristics of each substance. The company is verifying whether the target concentration can be achieved, as well as whether the antibody’s structure and activity are maintained, and assessing factors such as aggregation, denaturation, particle size, redispersibility, injectability, and short-term and accelerated stability.

CEO Kim stated, “Although the pace of progress varies by project, we expect that concrete discussions regarding subsequent stages will be possible for some projects as early as the first half of next year.”

He added that the company is also conducting technical reviews—prior to signing Material Transfer Agreements (MTAs)—with multiple overseas pharmaceutical and biotech companies in Japan, the U.S., and elsewhere. Inventage Lab Inc. plans to hold meetings with potential partners at “Bio Asia,” which begins on the 1st in Singapore, while also continuing separate discussions with global companies at its headquarters.

CEO Kim stated, “In recent partnering meetings, inquiries and discussions regarding IVL-Biofluidic have been increasing alongside those about our existing long-acting injectable technology,” adding, “There are companies showing interest in the technology’s uniqueness and its potential for actual commercialization.”

Halozime Also Secures Ultra-High-Concentration Technology… Expanding the Next-Generation SC Market

Inventage Lab Inc.’s IVL-Biofluidic is a platform designed to convert intravenous (IV) antibody injections into subcutaneous (SC) formulations that can be administered quickly at medical facilities or self-administered by patients. While Halozyme and Alteogen Inc.’s hyaluronidase-based technologies temporarily break down hyaluronic acid in subcutaneous tissue to create space for the drug solution to spread, IVL-Biofluidic removes water from the antibody to create microparticles, which are then dispersed in a small volume of solution.

The scope of SC formulation technology is also expanding from methods that create more space for the drug solution to spread to methods that reduce the volume of the drug itself. Halozime, which pioneered the hyaluronidase-based SC formulation market, acquired Electropay—owner of the “Hypercon” ultra-high-concentration microparticle platform—in November of last year for up to $900 million (approximately 1.2 trillion won), including an upfront payment and approval milestones. In December of the same year, Halozyme acquired SurfBio—which aims for concentrations of up to 500 mg/mL using protective additives and spray-drying technology—for up to $400 million (approximately 500 billion won), including an upfront payment and milestone payments.

The fact that Halozyme secured two ultra-high-concentration platforms in quick succession—even amid the commercial success of its enzyme-based “InHands”—demonstrates that the next-generation SC formulation market is expanding toward the administration of highly concentrated antibodies via small devices such as autoinjectors. While Electropay and SurfBio have each adopted different particleization and drying processes for their ultra-high-concentration methods, Inventage Lab Inc. has opted for a method that uses microfluidic technology to control particle size and manufacturing conditions.

IVL-Biofluidic reduces the volume of the antibody itself—without adding enzymes—to enable administration in volumes of around 1–3 mL, and is designed for use in pre-filled syringes (PFS), cartridges, and autoinjectors. The company announced that it has confirmed high-concentration particle formation of up to 500 mg/mL using a proprietary model antibody. Separately, it has also secured application data for various biopharmaceutical classes, including not only monoclonal antibodies but also polymeric proteins, antibody-drug conjugates (ADCs), and blood products.

Currently, the company has confirmed the initial formulation suitability of IVL-Biofluidic. Moving forward, it plans to sequentially secure data necessary for commercialization—including verification of target concentration and quality reproducibility using actual partner companies’ substances, as well as long-term stability, repeated-dose toxicity, immunogenicity, injection site reactions, pharmacokinetic equivalence, and container-syringe compatibility.

The long-term target of 750 mg/mL is not so much a factor that will immediately determine commercial success as it is an expansion metric that can broaden the platform’s scope of application. Even with the currently achieved 500 mg/mL, it is possible to contain 1,000 mg of antibody in 2 mL, enabling the development of a significant number of antibody drugs as low-volume subcutaneous (SC) formulations. Once the company reaches 750 mg/mL, the likelihood of applying even high-dose antibodies to small syringe devices is expected to increase, broadening the addressable market.

CEO Kim stated, “Rather than the maximum concentration itself, what is important is concentrating our clients’ actual antibodies to the target dosage while maintaining their activity and consistently delivering the same quality.” He added, “Since commercialization is fully feasible even at the current concentration, we are currently focusing on validation using partner materials.”
Parallelization of

Microfluidic Modules… Bridging the Gap to Clinical and Commercial Production

Another key development focus for Biofluidic is bridging the quality confirmed in the research phase to clinical and commercial production. By precisely controlling microfluidic flow and mixing conditions, the company reduces particle size variation and manages issues such as antibody damage or agglomeration during the manufacturing process. This process ensures consistent maintenance of key quality characteristics of the finished drug product, including antibody activity, redispersibility, injectability, and storage stability.

Generally, as the concentration of liquid antibodies increases, viscosity rises, requiring more force to push the syringe plunger and making it more difficult to pass through a fine needle. IVL-Biofluidic reduces the burden of administration by converting antibodies into a dehydrated microparticle form—rather than dissolving them in a high-viscosity liquid—and then suspending them in a low-viscosity diluent. CEO Kim added, “We are controlling particle size uniformly to ensure compatibility with fine needles, and we are also developing a diluent formulation that ensures stable particle dispersion.”

Production capacity is scaled up by connecting proven microfluidic modules in parallel or by operating them continuously. The company explains that this allows for increased throughput while maintaining the fluidic conditions established during the research phase. Based on its microfluidic mass production technology—previously used for manufacturing long-acting injectables—Inventage Lab Inc. is developing dedicated IVL-Biofluidic modules and manufacturing processes. The company plans to secure the yield and batch-to-batch quality reproducibility required for clinical and commercial production by concurrently validating partner substances’ formulations and optimizing its production systems.

The business model consists of two approaches: either Inventage Lab Inc. receives antibody bulk solution from partner companies and produces the finished drug product (DP), or the company transfers the IVL-Biofluidic formulation and manufacturing process to contract development and manufacturing organizations (CDMOs) that produce the antibody bulk solution. This structure allows the company to expand its revenue streams beyond technology fees to include formulation development, manufacturing process transfer, engineering, and finished product manufacturing.

CEO Kim emphasized, “We have already exceeded this year’s target for IVL-Biofluidic Master Technology Agreements (MTAs), and additional discussions are ongoing,” adding, “We will focus on verifying the technology’s applicability and production reproducibility using actual partner compounds to secure joint development and commercialization agreements.”