Products from research to commercialization
We provide a common drug contact surface starting at the research and pre-clinical drug development phases, through clinical trials, and on through to commercial launch.
The coatings on our vials are chemically equivalent and provide an inert drug contact surface irrespective of container geometry. Coating equivalence is verified by a “Chemical fingerprint” (ex. FTIR, XPS, and Rutherford Backscattering).
The coatings are architected for desired characteristics; no risk of coating debonding; will not interact or react with contact by the drug product.
Our products are molded from engineered polymers and incorporate a thin, glass-like barrier coating system on the inside surface. We apply it to the inside surface of the container using plasma-enhanced chemical vapor deposition (PECVD).
The thinness of the coating creates significant advantages, including flexibility (not brittle like traditional glass) and excellent thermal, mechanical, and chemical characteristics. Our proprietary coating technology can be applied to any surface; even coating extreme aspect ratios and small volume containers are possible.
With more than 300 patents, our technology is our largest differentiator. No other company has been able to bring step-change innovation to pharma packaging for more than 50 years. All our competitors claim incremental improvements (10-15%) in reducing the above-mentioned problems.
We eliminate all of the problems.
Our vials have the following benefits:
- No silicone oil or baked-on silica, a major source of subvisible particles
- Subvisible particles in the container, primarily related to silicone oil droplets, are a source of immunogenicity and protein drug denaturing
- FDA defines immunogenicity as the propensity of the therapeutic protein product to generate immune responses to itself and to related proteins or to induce immunologically related adverse clinical events
- No adhesives (Tungsten-free)
- No particles
- No extractables
- No leachables
- No delamination
- No breakage on transport
- No breakage on automation lines
- The manufacturing process incorporates 100% inspection to achieve near 8 sigma quality
- Flexible attributes; container size/shape & formulation tolerance
- 6x lower complement activation vs glass. Reduces risks associated with immune response
- Tighter dimensional control – dimensional consistency 25x better than glass for more accurate dose delivery and more consistent device performance
- Containers are shatterproof – no breakage
- A chemically inactive organosilicate protective top layer eliminates metal ion leachables
- Silica-like barrier blocks oxygen and other gas permeation, assuring content integrity and shelf-life
- Glass-like appearance and high content visibility
- Can be molded to fit any type of FDA approved auto-injector or wearable device
- Flat bottom vials for lyophilization provide consistent heat transfer
- Serialization with unique ID stamped on each container for full traceability