No fridge, no problem: Stablepharma and AFT join forces to make critical drugs shelf-stable

Cold-chain dependency has long constrained the reach, cost-efficiency, and sustainability of sterile injectable medicines. Now, Stablepharma Limited and AFT Pharmaceuticals Limited (NZX: AFT; ASX: AFP) are aiming to disrupt that model. The two companies have signed a development and option-to-license agreement to create a new portfolio of thermostable, shelf-stable injectables targeting oncology and anti-infective treatments. With a combined global market valued at over USD 6 billion, the partnership marks Stablepharma’s expansion beyond vaccines and positions AFT Pharmaceuticals to diversify into cold-chain-free hospital products with significant access and cost advantages.

Why is the Stablepharma and AFT Pharmaceuticals deal a signal moment for cold-chain reform in specialty injectables?

This partnership represents a strategically timed response to longstanding challenges in pharmaceutical distribution, particularly for biologics and sterile injectables that are vulnerable to cold-chain disruption. Stablepharma’s proprietary stabilisation platform, known as StablevaX, has previously been focused on vaccines. Its redeployment toward sterile non-vaccine injectables signals a new phase of technological applicability, one that addresses persistent logistical and access challenges across both high-income and resource-limited healthcare markets.

The decision by AFT Pharmaceuticals Limited to co-develop these formulations rather than license completed assets underscores its growing emphasis on upstream innovation. For a company that has historically built its portfolio through in-licensing and local market commercialisation, the partnership suggests a shift toward deeper control over product differentiation and supply chain dynamics. As hospital buyers and global procurement agencies increasingly factor sustainability and resilience into tender evaluations, cold-chain independent therapies may gain competitive preference.

Fridge-free injectables are not simply a matter of convenience. In low-resource settings, the absence of reliable refrigeration infrastructure severely limits the delivery of essential medicines. Even in mature markets, cold-chain complexity contributes to significant financial and environmental cost. Stablepharma Limited’s entry into this domain with a credible pharmaceutical partner enhances its strategic relevance and moves the concept of ambient-stable injectables closer to commercial reality.

How does this agreement redefine Stablepharma’s commercial model and industry positioning?

Stablepharma’s technology platform is defined by its ability to eliminate cold storage requirements without compromising pharmaceutical stability or efficacy. As explained by Chief Development Officer Dr Karen O’Hanlon in an interview with Business News Today, the company’s mission is “to revolutionise vaccine and pharmaceutical distribution by leveraging our proprietary StablevaX technology platform to reformulate and thermostabilise both existing and emerging temperature-sensitive products.” With this agreement, Stablepharma Limited is broadening that platform beyond vaccines into hospital therapeutics, allowing it to address more commercially lucrative and operationally constrained areas of sterile injectable delivery.

Importantly, the agreement is structured as a development and option-to-license deal. This allows Stablepharma to remain capital-light while building a portfolio of intellectual property-driven formulation enhancements. Rather than manufacturing or commercialising products directly, Stablepharma will license out its stabilised formulations and receive milestone-based payments and royalties upon commercialisation. This creates a scalable and de-risked revenue model for a technology platform company operating at the interface of formulation science and public health utility.

From a competitive perspective, this agreement improves Stablepharma’s visibility among potential partners seeking formulation upgrades for injectable portfolios. Whether in oncology, anti-infectives, or other temperature-sensitive biologics, the opportunity to extend shelf life and reduce cold-chain costs may prove compelling for pharmaceutical manufacturers seeking supply chain optimisation or differentiation in crowded markets.

What does this strategic move mean for AFT Pharmaceuticals and its expansion narrative?

For AFT Pharmaceuticals Limited, the partnership with Stablepharma supports multiple strategic objectives. First, it reinforces the company’s intent to move beyond its core strength in over-the-counter and primary care prescription segments into more complex hospital therapies. The development of thermostable injectables in oncology and anti-infectives adds high-margin, high-impact therapeutic categories to its pipeline and positions AFT Pharmaceuticals to compete for institutional and government tenders.

Second, it allows AFT Pharmaceuticals to anchor its future growth in differentiated innovation, particularly in Asia-Pacific markets where temperature resilience remains a key determinant of access. Countries such as Malaysia, Indonesia, and the Philippines represent expanding hospital markets with variable refrigeration infrastructure. Products that do not require consistent cold storage could enable faster market entry, broader coverage, and more favourable economics for hospital buyers.

Third, the collaboration underscores AFT Pharmaceuticals’s increasing orientation toward ESG-conscious product development. In an era where healthcare systems are scrutinising the carbon footprint of pharmaceutical supply chains, cold-chain elimination provides an environmental value proposition that aligns with investor and stakeholder expectations. AFT Pharmaceuticals could leverage this positioning not only to strengthen its brand narrative but also to satisfy procurement frameworks that include sustainability as an evaluative criterion.

What are the technical and regulatory hurdles that could impact execution?

While the strategic intent behind the partnership is clear, execution will require careful navigation of technical and regulatory complexities. Reformulating existing injectables into thermostable versions involves more than simple excipient swaps. The chemical and physical stability of active pharmaceutical ingredients at elevated temperatures must be validated under International Council for Harmonisation guidelines. In some cases, the reformulated product may be considered a new drug entity by regulators, requiring bridging studies or full clinical trials.

Additionally, manufacturing process validation will be critical. Stablepharma’s technology must be seamlessly integrated into existing good manufacturing practice (GMP) workflows for sterile fill-finish products. Any deviation from validated protocols could introduce regulatory delays or increase cost of goods sold. Cold-chain replacement technologies must also demonstrate equivalence in safety, efficacy, and immunogenicity, depending on the therapeutic class.

There is also an adoption curve to consider. Hospital pharmacists, oncologists, and infectious disease specialists may require education and data to accept new thermostable presentations, particularly if storage and handling protocols differ from standard products. This introduces a commercial risk for AFT Pharmaceuticals, which will need to build awareness and clinician confidence without the benefit of prior market examples.

How might the broader pharmaceutical industry respond to a successful rollout of thermostable sterile injectables?

Should the Stablepharma and AFT Pharmaceuticals partnership yield viable commercial products, it could catalyse broader industry interest in cold-chain elimination strategies. Large pharmaceutical companies with legacy portfolios in anti-infectives or oncology injectables may seek to retrofit existing products with thermostable technology, particularly where patents are expiring and lifecycle extension becomes a priority.

Contract development and manufacturing organisations (CDMOs) may begin investing in capabilities to accommodate thermostabilisation processes, including lyophilisation upgrades and new stability testing protocols. This, in turn, could establish thermostable injectables as a value-added service line within the pharmaceutical manufacturing ecosystem.

The implications for low- and middle-income countries could be especially pronounced. Donor agencies and procurement consortia such as Gavi, the Vaccine Alliance or the Global Fund to Fight AIDS, Tuberculosis and Malaria may begin favouring ambient-stable formulations in tenders as a means to reduce spoilage, wastage, and emissions. Governments seeking to expand universal healthcare access may also prioritise medicines that are operationally easier to distribute and stock in rural areas.

Ultimately, this development may nudge regulators, especially those in emerging markets, to create expedited pathways for thermostable reformulations, particularly for drugs listed on the World Health Organization’s Essential Medicines List. In the longer term, cold-chain independence may become a defining feature of pharmaceutical resilience planning and pandemic preparedness frameworks.

How does this agreement reflect shifting capital allocation strategies in biotech and pharma?

One of the more subtle takeaways from the Stablepharma and AFT Pharmaceuticals partnership is its capital-efficient structure. Instead of investing in expensive manufacturing facilities or proprietary pipelines, Stablepharma is building platform value by securing downstream licensing partners who assume regulatory and commercialisation responsibilities. This model reduces dilution, accelerates validation, and allows the company to focus on core scientific innovation.

Similarly, AFT Pharmaceuticals gains access to a novel technology platform without having to acquire a formulation company outright. The option-to-license structure also allows for asset selectivity, enabling AFT Pharmaceuticals to exercise rights only on formulations that meet internal strategic or commercial thresholds.

This signals a broader trend in biotech and specialty pharma toward modular, partnership-driven expansion. Rather than taking on full-stack development risk, companies are increasingly forming focused alliances to unlock platform synergies. In a capital-constrained market environment, this form of asset-light innovation is likely to persist.

Key takeaways on what this development means for Stablepharma, AFT Pharmaceuticals, and the industry

• Stablepharma and AFT Pharmaceuticals have entered a development and option-to-license agreement for fridge-free sterile injectables in anti-infectives and oncology.

• The partnership marks Stablepharma’s first formal expansion into non-vaccine therapeutics using its proprietary StablevaX platform.

• Fridge-free injectable formulations could significantly improve access, reduce wastage, and eliminate cold-chain infrastructure in low-resource regions.

• AFT Pharmaceuticals is diversifying into IP-driven innovation with hospital-grade products, adding strategic depth beyond its OTC and primary care portfolio.

• Regulatory approvals will require new stability and efficacy data, with execution risks around manufacturing alignment and clinician adoption.

• The move could prompt legacy pharma and CDMO players to explore licensing or developing thermostable formulations to remain competitive.

• Institutional investors may see this as a low-cost pathway for AFT to enter premium segments with differentiated products in global markets.

• Thermostable injectables support ESG goals by reducing emissions, improving access, and increasing system-wide resilience.