AAV ophthalmic gene drug packaging-COP

In 2017, the world's first ophthalmic gene therapy, Luxturna, was approved for marketing in the United States, setting off a craze for ophthalmic gene therapy, and major companies have begun to make plans. According to incomplete statistics, there are nearly 30 pharmaceutical companies in China deploying AAV ophthalmic gene therapy, and the intensity is evident. So, as a special drug, what are its packaging requirements?

RTU(ready to use) 2ml COP vial

Polymer Vial for cell and gene therapies

1. Packaging materials: Packaging materials for AAV gene therapy drugs should have a high degree of biocompatibility and chemical stability. For example, cyclic olefin polymer COP has good drug solubility resistance and protective properties, and can ensure long-term stability even for drugs with a pH value greater than 10.

2. Temperature resistance: AAV gene therapy drugs need to withstand certain temperature conditions during the packaging process, including preparation, sterilization and storage. Therefore, packaging materials must have high temperature resistance and be able to maintain stability at appropriate temperatures and not be affected by thermal decomposition or chemical changes. COP vials can withstand environments ranging from -196°C to 121°C and are excellent in temperature resistance.

3. Oxygen and humidity barrier properties: AAV gene therapy drugs are highly sensitive to oxygen and humidity, so packaging materials need to have good barrier properties to avoid the penetration of oxygen and humidity. COP raw materials have very high barrier properties and are ideal materials for high-end pharmaceutical packaging.

4. Sealing: Packaging containers need to have good sealing performance to effectively prevent drug leakage or the intrusion of external contamination. COP vials with rubber stopper aluminum caps can achieve good sealing of packaging and create a stable storage environment for drugs.

In addition to the above requirements, the packaging of AAV ophthalmic gene drugs also needs to comply with the regulations and requirements of relevant regulatory agencies (such as drug regulatory agencies). These regulations include labeling and package insert requirements, batch tracking, and quality control to ensure the safety and effectiveness of gene therapy drugs. The Chinese CDE registration number of Xinfuda COP bottles has been activated and has been registered through the US DMF, which can help your drugs go on the market faster.