In Biopharmaceuticals: How COP Vials Help Reduce Drug Loss and Packaging Risks

In the field of biopharmaceuticals, every milligram of protein-based drugs and every milliliter of cell therapy products carries significant value. However, industry data shows that a considerable portion of biologic drug activity can be lost during storage due to packaging-related issues—either through adsorption to the container surface or due to seal failure caused by temperature fluctuations. This invisible loss not only drives up production costs but may also compromise therapeutic efficacy. The unique properties of COP (Cyclic Olefin Polymer) vials are helping pharmaceutical companies tackle these critical pain points.

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

Invisible Losses: How Protein Adsorption Impacts Biologics Production

Monoclonal antibodies, enzymes, and other protein-based drugs are prone to binding with glass surfaces. This adsorption leads to two major issues:

The actual delivered dose is lower than the labeled amount, reducing therapeutic effectiveness.

Manufacturers are forced to overfill to compensate for losses, significantly increasing production costs.

Thanks to its low surface energy and hydrophobic nature, COP material dramatically reduces protein adsorption. Industry research shows that compared to traditional glass packaging, COP vials can significantly improve the recovery rate of protein drugs. This advantage has been validated in monoclonal antibody production by multiple biopharmaceutical companies.

Cryopreservation Challenges: Why Cell Therapy Products Need COP Packaging

Cell therapy products pose even greater challenges to packaging due to:

Increased sensitivity of formulations

Risk of glass vial breakage during rapid thawing

Extreme sensitivity of live cells to leachables and extractables

Under ultra-low temperatures, glass vials and rubber stoppers contract at different rates due to mismatched material properties, which can compromise seal integrity. COP materials, with thermal expansion coefficients closer to those of rubber stoppers, maintain a more secure seal in freezing conditions. With excellent thermal stability ranging from -196°C to 121°C, COP vials ensure safety throughout the entire process—from cryopreservation to clinical use.

sterile vial in tray

Regulatory Advantage: How COP Simplifies Regulatory Submissions

As regulatory authorities around the world tighten standards for packaging materials, the inherent advantages of COP provide added value for pharmaceutical companies:

Compliance with pharmacopeial standards such as USP <660> and EP 3.2.2

Availability of complete extractables and leachables (E&L) data packages

Suitable for high-standard applications like gene therapy and advanced biologics

Using pre-validated COP vials can significantly reduce the workload related to compatibility studies, streamlining the regulatory process and accelerating time to market.

A Smarter Choice in Biologics Manufacturing

As biopharmaceutical production costs continue to rise, COP vials offer a rational and strategic solution—minimizing drug loss, reducing cryopreservation risks, and simplifying regulatory compliance. The value of COP is not just in cost savings per vial, but in providing comprehensive protection for high-value biologics, ensuring every dose delivers its full therapeutic potential.