Complex biologic drugs encounter several challenges in primary packaging. Any interaction between the drug and the prefilled syringe can affect stability and treatment efficacy. For instance, silicone could interact with the drug, and tungsten residues may lead to protein degradation or aggregation.
Alba® syringes minimized risk of drug-container interaction for biologics.
They represent the best-in-class solution for biologics and ophthalmic applications minimizing the risk of drug-container interaction and addressing the key requirements of protein-based drugs, and minimizing adsorption, aggregation and inorganic extractable interaction.
All Alba® products have an internal coating, based on standard silicone oil, which is cross-linked. It ensures that particle levels - caused by silicone migration during container storage - are significantly lower than ones using standard siliconization technologies.
Moreover, the internal treatment offers superior gliding performance, reducing the risk of functional issues when combined with auto-injectors.
Alba® glass syringes are available as prefillable solutions in our EZ-fill® configuration.
Watch the video about Alba® syringe feature and advantages and discover the manufacturing process.
The low silicone-drug interaction helps to maintain the injection time and dose delivery with an auto-injector.
STAKED NEEDLE | LUER | |||
---|---|---|---|---|
mL |
RNS |
sTW |
ITC |
OVS |
0.5 mL | ||||
1.0 mL long | ||||
2.25 mL |
Off the shelf
To be developed
Available soon
Due to the excellent properties of the layer, Alba® platform mitigates packaging-related risks and enhances drug-interaction stability.
Particle reduction - Minimized subvisible particles versus conventional sprayed-on siliconized containers to alleviate potential drug-silicone interaction.
Optimized break-loose and glide performance - Silicone lubricant layer integrity, optimized to withstand challenging formulations and aggressive conditions, helps conserve gliding performances throughout the drug shelf-life.
Reduction risk of stalling and injection time variation
Inorganic extractable mitigation - A barrier between the drug and the glass reduces the amount of inorganic extractables.
Time stability - Alba® inner coating does not undergo critical variations after contact with the placebo solution over a period of 6 months (tested @40°C/75%RH).
Alba® syringe can meet complex biologic drugs needs.
Protein-based therapeutics
Ophthalmic applications
mRNA-based applications