Prefilled Nasal Spray for Injectable Drugs Validated by NEST

Understanding the Shift Toward Prefilled Nasal Spray for Injectable Drugs

The pharmaceutical and medical device industry is increasingly examining alternative delivery routes for medications that have traditionally been administered via injection. This interest stems from a well-documented industry pain point: the rising incidence of chronic diseases has placed growing pressure on clinical resources, increased the risk of needle-stick injuries, and created ongoing concerns about medication waste. Against this backdrop, prefilled nasal spray systems are being explored as a complementary or alternative format for certain drug formulations, offering precision dosing and self-administration potential without the handling complexities associated with needles.

Why Non-Invasive Delivery Matters

Self-administration solutions that reduce clinical workload while improving patient compliance are central to addressing the pain points described above. A device that allows a patient to self-dose accurately, without the training typically required for injections, can meaningfully reduce the burden on healthcare systems. This is the strategic rationale behind pharmaceutical packaging and drug delivery innovation focused on both injection and inhalation methods, including nasal delivery technologies.

Wuxi NEST Biotechnology’s Nasal Delivery Line

Wuxi NEST Biotechnology Co., Ltd., operating under the brand name NEST, was founded in 2018 with a strategic focus on pharmaceutical packaging and drug delivery technologies. As part of its product and service matrix, the company maintains a dedicated Nasal Delivery Line consisting of two core offerings: the Disposable Intranasal Atomization Device and the Prefilled Nasal Spray Assembly.

Disposable Intranasal Atomization Device

NEST obtained registration for its Disposable Intranasal Atomization Device in 2019, marking an early milestone in the company’s development history. This device is designed for intranasal administration and has been validated in real-world clinical applications, as demonstrated in the company’s documented customer case involving a Lyophilized Live Attenuated Influenza Vaccine.

Prefilled Nasal Spray Assembly

Complementing the atomization device, the Prefilled Nasal Spray Assembly is positioned within NEST’s broader one-stop pharmaceutical packaging offering. Like the rest of the company’s product portfolio, it is developed within an integrated framework that spans independent mold design, in-house research and development, automated mass production, and global logistics support — allowing the assembly to be customized and delivered as part of a coordinated drug-device combination strategy.

Engineering Behind the Platform

Full In-House Industry Chain

A defining characteristic of NEST’s approach is its full in-house industry chain, covering everything from independent mold design and R&D through to automated mass production and global logistics. This vertical integration allows the company to maintain tighter control over product consistency, which is particularly important for devices intended for precision dosing. NEST also offers Freedom to Operate (FTO) analysis across major global markets — including China, the United States, the United Kingdom, and Europe — to help mitigate patent-related risks for its drug-device combination products.

Cleanroom Manufacturing and Quality Assurance

NEST’s manufacturing infrastructure includes 10,600 square meters of Class 100,000 cleanrooms and 3,600 square meters of Class 10,000 cleanrooms, supported by a dedicated 2,300 square meter pen injector workshop. Quality oversight is managed by a 76-person specialized quality team, while a 50-person mold maintenance team supports the company’s independent mold center, which has delivered more than 300 precision molds to date. Across its broader production processes, NEST applies 100% multi-angle CCD camera inspection and maintains moist heat sterilization capabilities rated at SAL 10⁻⁶, reflecting the rigor applied throughout its manufacturing operations.

Proven Performance: Case Study

One of the clearest illustrations of NEST’s nasal delivery capability comes from its documented case involving a Lyophilized Live Attenuated Influenza Vaccine, where the business scenario centered on intranasal vaccination. The solution applied was the Disposable Intranasal Atomization Device, and the quantified result reported was the successful stimulation of a triple immune response — encompassing mucosal, humoral, and cellular immunity. This case demonstrates the device’s functional relevance to intranasal administration scenarios and provides a concrete data point for evaluating the platform’s performance.

Complementary Packaging Capabilities for Injectable Drugs

While the Nasal Delivery Line addresses non-invasive administration, NEST’s broader Primary Packaging Line remains closely tied to injectable drug formats. This includes RTU Cartridges made from borosilicate glass and manufactured using NEST’s proprietary cross-linked siliconization technology, which supports stable gliding performance in syringes and cartridges and is available in 1.5mL, 2.0mL, and 3.0mL formats. The company also offers the COP/COC Prefillable Vial, branded as AccureVial®, positioned as a high-quality alternative to borosilicate glass for sensitive biologics, with low protein adsorption, shatter-resistant COP material, and temperature tolerance ranging from -196°C to 121°C. These packaging solutions, alongside the COP/COC Prefilled Syringe Assembly, illustrate how NEST supports the injectable drug ecosystem in parallel with its nasal delivery offerings, giving pharmaceutical partners access to both delivery formats under one supplier relationship.

Certifications and Global Compliance

NEST’s product development is underpinned by a substantial body of international certifications and regulatory filings. These include ISO 9001, ISO 13485, ISO 11137, ISO 15378, IATF 16949, CE MDR Certification, and MDSAP Five-Country Certification covering the United States, Canada, Australia, Japan, and Brazil. The company also holds US FDA 510(k) clearances (K240961, K240774), US DMF filings (No. 40744, No. 42439, No. 40922), Canada Medical Device Licenses (No. 113733, No. 112619), and a China Class II Medical Device Certificate. Third-party certification bodies such as TÜV SÜD have verified NEST’s ISO 9001, 13485, and 11137 compliance. NEST is also identified as a provider of the first moist heat sterilized cartridges in China, reflecting the depth of its sterilization technology investment.

Global Footprint and Service Model

NEST’s headquarters and R&D functions are based in Wuxi, Jiangsu, China, with subsidiaries and warehouses extending across the United States (Woodbridge, NJ and Phoenix, AZ), the Netherlands (Hendrik-Ido-Ambacht), the United Arab Emirates (Sharjah), Japan (Yokohama), and Turkey (Istanbul). This integrated warehousing network across the US, Europe, and Asia is designed to shorten lead times for international customers. The company’s service model is built around one-stop solutions covering R&D, production, pre-sterilization, and customized assembly, along with pre-sales customization, technical validation, automated assembly line planning, and global logistics support — services that extend to its nasal delivery and injectable packaging product lines alike.

A Partner for Drug-Device Combination Strategy

For pharmaceutical companies evaluating delivery formats for injectable drugs — including insulin, GLP-1, and FSH manufacturers — NEST’s combination of nasal delivery technology, injectable packaging capability, full-chain manufacturing, and documented regulatory compliance offers a structured pathway for exploring prefilled nasal spray applications alongside existing injectable formats. With its roots in precision dosing and self-administration solutions, Wuxi NEST Biotechnology continues to position its Nasal Delivery Line as part of a broader strategy to empower global advancement of drug-device combinations through smarter, more targeted treatment options.

https://www.cell-nestbio.com/
NEST Biotechnology Co., Ltd.