The PFS, dubbed Schott TOPPAC freeze, is designed using an advanced pharmaceutical-grade cyclic olefin copolymer (COC), a break-resistant, biologically inert material that features advanced barrier properties to provide drug stability
German drug delivery solutions provider Schott Pharma has rolled out pre-fillable syringes (PFS) for deep-cold drugs, stored and transported at temperatures as low as -100°C.
The PFS, dubbed Schott TOPPAC freeze, is designed using an advanced pharmaceutical-grade polymer and delivered to pharma companies in a standardised nest and tub configuration.
The German drug delivery company said that its new PFS product is compatible with major fill-and-finish lines to simplify the filling process.
Also, drug manufacturers can benefit from its extensive scientific data package that details the 1ml long syringes’ performance at deep-cold temperatures.
The Schott TOPPAC freeze will enhance the quality, specification, and supply process to help drug manufacturers achieve a quicker time to market, said the company.
Schott Pharma CEO Andreas Reisse said: “While pre-fillable syringes are typically favoured for drug delivery due to their speed and convenience, they were not a viable option for drugs that require storage at -100°C.
“But now, for the first time, deep-cold medications can be introduced to the market using pre-fillable polymer syringes.
“The drug development pipeline for these drugs is extensive, including various therapies such as mRNA, cell, and gene therapies.”
According to the company, deep-cold medications require advanced drug delivery systems that can survive harsh conditions.
Schott said that its polymer PFS will protect the drugs at temperatures as low as -100°C while maintaining syringe functionality, such as breaking loose and gliding force and closure integrity.
The Schott TOPPAC freeze drug delivery system is made of cyclic olefin copolymer (COC).
COC is a break-resistant, biologically inert material that features advanced barrier properties to provide drug stability.
Also, the company’s scientific data package includes data on container closure integrity, functionality, and particulate generation after freeze and thaw cycles.
In addition to polymer syringes, Schott also offers a portfolio of deep-cold delivery systems including vials for a rapid launch and fast time-to-market, along with glass syringes.
Schott Pharma drug delivery systems business segment head Mario Haas said: “Our polymer syringes are a favourable choice for deep-cold drugs thanks to the entire platform system, which includes the polymer material, siliconisation, the plunger material, and the overall quality management system, among others.
“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. 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 fulfils the high requirements needed for deep-cold applications.”