First on the market: Safely storing deep-cold medications with prefillable polymer syringes
Wednesday, May 17, 2023, Mainz, Germany
- SCHOTT Pharma’s prefillable polymer syringes are a trailblazing solution for drug applications that need to be stored and transported on dry ice at temperatures approaching -100°C.
- Top players in the field are in the process of commercial approval for mRNA applications in SCHOTT Pharma’s prefillable polymer syringes.
- Scientific data packages on the syringes’ performance at deep-cold temperatures support pharma companies in bringing their drugs to market.
Deep-cold medications require innovative delivery systems that can withstand harsh conditions. SCHOTT Pharma’s polymer PFS were developed to protect these drugs even at temperatures approaching -100°C while maintaining syringe functionality, such as break loose and gliding force and container closure integrity. “Our polymer syringes are a favorable choice for deep-cold drugs thanks to the entire platform system, which includes the polymer material, siliconization, the plunger material, and the overall quality management system, among others,” explains Mario Haas, Head of Business Segment Drug Delivery Systems at SCHOTT Pharma. “Based on our track record in the field of mRNA-based applications, we are ready to bring the next deep-cold drugs to the market together with our customers.”
High-quality portfolio for deep-cold medications
Known as SCHOTT TOPPAC® freeze, the drug delivery system is made of cyclic olefin copolymer (COC). The material is break-resistant, biologically inert, and features advanced barrier properties to ensure drug stability. In addition, the scientific data package includes data on container closure integrity, functionality, and particulate generation after freeze and thaw cycles. “Furthermore, our state-of-the-art manufacturing process is designed to achieve consistently high quality. Combined with enhanced quality control of all critical to quality (CtQ) syringe attributes, we can ensure that each polymer syringe fulfills the high requirements needed for deep-cold applications,” adds Haas.
The polymer syringes are part of SCHOTT Pharma’s portfolio, which features solutions for all life cycle stages of deep-cold medications. Besides polymer syringes, the deep-cold portfolio includes vials for a quick launch and fast time-to-market as well as glass syringes.
Public Relations Manager