COP Vials: Overcoming Material Shrinkage in Cryogenic Storage

 While much attention is given to temperature control in biopharmaceutical cold chains, one often overlooked factor threatens drug integrity: material shrinkage. When standard vials contract unevenly during freezing, microscopic gaps form at the stopper interface, creating pathways for contamination. This silent failure mode has led to costly product recalls and efficacy loss in mRNA vaccines, protein therapies, and cell-based medicines.

Polymer Vial 2ml 5ml 10ml for cell and gene therapies

Why Traditional Solutions Fall Short

 

Glass vials, despite their widespread use, exhibit brittle fracture behavior below -80°C and suffer from mismatched shrinkage rates with elastomeric closures. Even cyclic olefin copolymer (COC) alternatives show 1.5-2% dimensional change at liquid nitrogen temperatures—enough to break sterile barriers. The pharmaceutical industry has long accepted these compromises, implementing workarounds like:

 

Overly thick stoppers (increasing particulates)

 

Secondary packaging (adding cost/complexity)

 

Narrower temperature bands (limiting flexibility)

 

The COP Advantage: Precision Engineering at Molecular Level

 

COP vials achieve breakthrough performance through polymer crystallinity control. During manufacturing, the cycloolefin chains align into a thermodynamically stable configuration that delivers three key benefits:

 

Near-Zero Hysteresis Shrinkage (0.3% at -196°C vs. 1.8% for COC)

 

Coefficient of Thermal Expansion (CTE) matching with bromobutyl stoppers (Δα < 0.5×10⁻⁶/°C)

 

Anisotropic Contraction that maintains critical seal zones

 

Independent testing by NSF International confirmed COP vials maintain >95% seal integrity after 50 freeze-thaw cycles (-196°C to 25°C), compared to <60% for glass counterparts.

RTU vial

Real-World Impact on Advanced Therapies

 

Case Study: A leading mRNA vaccine producer reduced lyophilization cake defects by 73% after switching to COP vials, attributed to:

 

Elimination of "cold cracks" during -70°C storage

 

Consistent inner vial geometry for precise fill volumes

 

No delamination risks during rapid thawing

 

Future-Proofing the Cold Chain

 

As gene therapies push storage requirements toward -150°C and regulatory agencies tighten container closure integrity (CCI) standards, COP's material science advantages position it as the only viable solution for next-generation requirements.

 

For pharmaceutical engineers evaluating cryogenic packaging, the question is no longer whether to adopt COP vials, but how quickly they can requalify their cold chain logistics around this enabling technology.

COP vial: a new packaging for cell therapy drugs

With the rapid development of cell therapy, its application value in the fields of cancer, blood diseases, cardiovascular diseases, etc. has become increasingly prominent. However, cell therapy drugs have extremely stringent requirements for packaging, and traditional packaging materials often cannot meet their special needs. Cyclic olefin polymer (COP) vials have become an ideal packaging choice for cell therapy drugs due to their unique performance advantages.

RTU(ready to use) 2ml COP vial

Challenges of cell therapy drugs to packaging

Cell therapy drugs usually contain protein components, which are easily adsorbed on the packaging surface, resulting in drug waste and inaccurate dosage. In addition, cell drugs need to be stored in ultra-low temperature environments (such as liquid nitrogen environments) to maintain drug activity. Therefore, packaging materials must meet the following two core requirements:

1. Low protein adsorption: avoid drug waste and ensure accurate dosage;

2. Excellent low temperature resistance: maintain stability in ultra-low temperature environments to ensure drug activity.

How do COP vials meet the needs of cell therapy drugs?

1. Low protein adsorption: COP vials have extremely low protein adsorption characteristics, which can effectively prevent drug components from being adsorbed on the packaging surface, ensuring the accuracy of drug dosage and the stability of efficacy. This feature makes it an ideal choice for protein drugs and cell therapy drugs.

2. Excellent low temperature resistance: COP vials can still maintain excellent physical and chemical stability in ultra-low temperature environments, and can withstand the extreme conditions of liquid nitrogen storage, ensuring that the activity of cell therapy drugs is not affected during storage and transportation.

Application of COP vials in the field of cell therapy

At present, COP vials have been widely used in the packaging of a variety of high-value cell therapy drugs, including:

Immune cell therapy drugs: such as CAR-T cell therapy drugs;

Stem cell therapy drugs: used to repair tissue and organ damage;

Gene therapy drugs: such as drugs used to treat genetic diseases.

Strict quality inspection to ensure drug safety

sterile vial in tray

The production process of COP vials follows strict quality inspection standards, including:

Appearance inspection: transparency, surface finish, no blisters, oil stains, etc.;

Performance inspection: sealing, absorbance, acidity and alkalinity, total organic carbon, etc.;

Biocompatibility inspection: cytotoxicity, skin sensitization, hemolysis, etc.

These inspection items ensure the stability and safety of COP vials during drug storage and transportation, and provide a reliable packaging solution for cell therapy drugs.

COP vials are an ideal choice for cell therapy drug packaging due to their low protein adsorption and low temperature resistance. They can not only meet the special needs of cell therapy drugs, but also provide pharmaceutical companies with safe and reliable packaging solutions, helping the rapid development of the cell therapy field.