SGD Pharma has announced a strategic collaboration between France and the US with Prince Sterilisation Services to validate Ready-to-Use (RTU) Type I glass primary packaging solutions for the North American market.
The first significant result of this collaboration is the My Sterinity Nasal platform, which introduces a new range of flexible, cleaned vials within SGD Pharma's My Sterinity RTU platform. These vials utilise the company's U-Save Type I vials, which are specifically designed to support the growing market for high-value nasal drug delivery.
The vials will initially be available in 3.5 ml, 7.5 ml and 10 ml formats, in both clear and amber glass and offer controlled particulate and endotoxin levels for enhanced purity, as well as biologically inert Type I sterile glass.
They will also be compatible with standard nasal preservative-free pump systems.
The My Sterinity Nasal product range will be manufactured at SGD Pharma's flagship facility located in Saint-Quentin-La-Motte, northern France.
Meanwhile, Prince will offer washing, depyrogenation and sterilisation services in North America. The collaboration, the pair say, will ensure a validated regional supply chain that meets the qualifications for US biopharmaceutical customers.
Why this matters
The global nasal market is valued at €9bn, with more than 2 billion units sold.
Traditionally, this market has been dominated by plastic materials. However, glass offers significant advantages, including greater chemical inertness, enhanced barrier protection and improved long-term biocompatibility.
These properties are essential for maintaining product integrity, minimising adsorption and ensuring sterility in therapies used for extended periods.
Previously focused on acute rescue treatments, the nasal market is now expanding to include more advanced, long-term therapies for conditions such as Alzheimer's, Parkinson's disease, multiple sclerosis and depression.
These treatments require primary packaging that ensures sterility, consistency and precise dosing. As a result, Type I glass has become the preferred material to ensure the long-term stability of these therapeutic products.
Production of the My Sterinity Nasal range will take place at SGD Pharma's flagship Saint-Quentin-La-Motte (SQLM) manufacturing facility in northern France, while Prince will provide washing, depyrogenation and sterilisation services in North America, ensuring a validated, regional supply chain qualified for US biopharmaceutical customers.
Carole Grassi, Chief Commercial Marketing & Innovation Officer, SGD Pharma, commented: "Our collaboration with Prince marks an important milestone in SGD Pharma's innovation growth strategy for North America."
The My Sterinity Nasal platform represents a major step forward in high-value nasal drug delivery and our collaboration with Prince unlocks immediate US-qualified capacity for biopharma customers scaling complex nasal therapy programmes.
"This is more than a product launch, it is a validated supply chain ready to support qualification, clinical trials and commercial launch with unmatched speed and reliability.”
Dr Daniel Prince, CEO of Prince, added: "SGD Pharma's Type I glass expertise combined with our quality-focused and flexible RTU & sterilisation platform creates the gold standard for sterile nasal packaging."
"Prince's recent US qualification means we can now deliver ready-to-use, terminally sterilised My Sterility Nasal vials in timelines that match domestic and international customer development cycles and exceed quality requirements.”
Heather Moore, Vice President of Sales Americas, said: "SGD Pharma is a reliable, high-performing partner to help customers scale, qualify, or develop new products swiftly and with confidence."
As the industry adjusts to changing supply chain dynamics, the addition of My Sterinity Nasal to SGD Pharma's production lines delivers increased capacity to the US market for Type I moulded glass vials.