Pharma & Biotech
Learn about SiO2’s innovations for the pharmaceutical industry
SiO2 Materials Science is a company with deep roots in chemistry and engineering. The company creates engineered container components for the Pharmaceutical and Biotechnology industry. These containers typically take the form of syringes, vials, and cartridges.
Our patented technology applies a unique glass-like barrier onto any plastic surface. Our products are engineered to combine the durability and dimensional precision of plastic with the physical and barrier properties of glass.
With the growth and adoption of biological drugs, nucleic acid-based vaccines, viral vectored therapies, and cell and gene therapies – container surface chemistry and manufacturing flexibility play an increasingly critical role in drug product commercialization.
In the pharma segment, SiO2 advanced technology solves more than 30 problems which have plagued the industry for more than 100 years – including some of the most challenging related to drug stability, drug efficacy, and safety.
Stability and Efficacy of the drug:
Biological drugs are extremely sensitive to the environmental conditions created by their packaging and delivery systems. Systems such as pre-filled syringes create additional challenges because they must function as both a storage container, impermeable to oxygen, as well as a working medical device capable of delivering a drug.
Systems based on plastic do not provide an effective oxygen barrier. Systems based on glass also have numerous issues: glass syringes must introduce foreign elements like silicon oil to work; glass has certain surface chemistry properties that in some cases can negatively interact with drugs or chemical reagents used as preservatives, reducing drug stability and shelf life. In some cases, the surface chemistry of glass causes aggregation of the drug to the bottom of the container, impacting optimal dose of the actual drug.
Si02 technology combines the best attributes of plastic and glass, without the drawbacks, and adds proprietary surface chemistry properties that improve drug stability and efficacy.
Elimination of Particles
Biological drugs and vaccines interact with subvisible particles, metal ions, leachables and silicon oil—all associated with glass. Average foreign particle count per dose can reach 150,000. Particles contribute to adverse patient outcomes, including patients developing neutralizing antibodies which reduce drug efficacy, as well as patient immunogenic responses that impact patient health and may even result in death. Si02 technology eliminates subvisible particles.
Thermal stability for advanced technologies
Nucleic acid (mRNA, DNA), cell & gene therapy, and viral vectored therapies require -80°C temperature compatibility. Traditional glass is compatible down to -40°C and fails at the required low temperatures. The SiO2 containers are compatible to -196°C.
Customized drug delivery systems
New biological drugs are increasingly demanding new, varied, and customized delivery systems. Auto-injectors and wearables require precision molding of plastic containers to ensure consistent functionality. Pre-filled syringes are being designed with new and varied shapes and specifications that are extremely difficult to mold and coat properly.
Dimensional variation of glass can also require overfilling of drug dose volume by up to 3% resulting in significant added cost. SiO2 containers have 10x of the dimensional precision of glass.
Glass containers break. One cracked vial can shut down an automated manufacturing line for a significant amount of time. One adverse event in this long process and production and delivery may be substantially delayed. Si02’s product is reduces breakage, saving drug companies potentially billions in elimination of waste, shut down costs and delays.
Drug companies demand the highest level of quality and consistency for the new class of biological drugs and therapies. Si02 has patented proprietary inspection methods that allow for 100% inline inspection, where the company captures more than 50 unique data points per unit. Most companies capture between 2-5 data points per unit. The result is Si02 reviews its product quality continuously and in real time, leading to significantly greater than six sigma quality standards. Our primary glass competitors operate at less than five sigma and manage their customer defects post-delivery to a customer.
Our Pharmaceutical Solutions Division has five areas of focus:
- Proprietary coated containers for biologics and ophthalmic components (syringes and vials)
- Common drug contact surface from bench to patient
- Cell Therapy & Car-T solutions
- Cryogenic vials (primary containers and cell banking)
- Lyophilization vials
Problems solved in the Pharma & Biotech Segment
- No Silicon Oil
- No Drug Interactions
- No Breakage
- Customized Containers
- No Oxygen Degradation
- No Breakage On Transport
- No Breakage On Automation Lines
Our proprietary technology allows us to maintain CCI and industry standard glide force and break loose without using silicone oil.
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.