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Optimized for vaccines, such as gene therapy and mRNA medications at temperatures down to -80°C.
February 7, 2024
By: Kristin Brooks
Managing Editor, Contract Pharma
SCHOTT Pharma, a provider of pharmaceutical drug containment solutions and delivery systems, is introducing glass vials optimized for deep-cold storage of drugs. Vaccines, such as gene therapy and mRNA medications must be frozen and transported at temperatures down to -80°C. Due to the high thermal stress and other factors in the freezing and thawing process, conventional vials are prone to glass breakage during the process, which results in costly downtimes and drug loss. To help prevent this, SCHOTT Pharma’s EVERIC freeze vials feature improved strength with optimized glass tubing, vial geometry and production process. “Our scientific strength tests have shown that the new vials outperform standard vials, making them a dedicated solution for frozen medications used to treat infectious diseases, cancer, and central nervous system disorders,” said Andreas Reisse, CEO of SCHOTT Pharma. In 2023, there were for example 11 mRNA drugs and 10 gene therapy drugs commercially available, which required deep-cold storage, and over 100 mRNA and 45 gene therapy drugs in clinical trials (Source: GlobalData). “By expanding our portfolio with the new vials, we are now the only partner to leading pharma companies, who can offer both polymer and glass solutions for deep-cold storage requirements,” said Reisse. Drug manufacturers look to ensure that the drug remains stable until it reaches the patient. For this, the container closure integrity (CCI) is crucial. However, deep-cold temperatures pose a risk because the stoppers can shrink and lose elasticity, which could affect the drug’s efficacy. Through scientific testing with eight variants, SCHOTT Pharma found a 0% failure rate for all configurations, showing that CCI can be maintained for all combinations within ISO dimensions, including EVERIC freeze vials. The new vials are manufactured in Müllheim, Germany, and can be supplied as ready-to-use (RTU) if requested and are available in 2 – 30 mL.
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