Cellular Therapy (Cell Therapy) is a type of regenerative medicine and is the process of introducing new cells into a tissue for the purpose of treating a disease. Cell therapies are commonly used in the research and production of bio-pharmaceutical therapies.
Single-Use Systems for Cellular Therapy
Single-Use Systems provide a range of benefits when implemented into cellular therapy process development. Customized solutions offer the best flexibility and scalability.
When selecting a contract manufacturer, the supplier must be able to exceed the requirements in order to deliver a safe and effective product. The supplier must also have the experience and knowledge to customize the product so it is suitable for its intended use.
Single-Use Systems Offer the Following Benefits:
- Minimizes Risk of Cross Contamination
- Cost Effective and Improves Production Efficiencies
- Facilitates Easy Scale-Up / Scale-Out Process for Commercialization
Additional Benefits to ASI's Single-Use Systems:
- Expertise in films / plastics / resins
- Knowledgeable in developing closed systems
- Performs Validation, Sterilization and Quality Assurance
- cGMP Compliant, ISO 13485:2003 Certified and FDA Registered
- Experts in developing scalable, safe and effective solutions
ASI's Length Experience Includes:
- Cell Collection & Separation: Our unsurpassed quality, delivery and customer service has made us the contract manufacturer of choice for many stem cell collection devices.
- Cell Culture: FEP bags are chemically and biologically inert, contain no plasticizers or chemical residuals, are breathable and impermeable to water. In addition, they posses 95% optical clarity which makes the contents viewable under magnification.
- Bio-Storage and Cryopreservation: ASI uses the highest quality films. All of the films (PE, PP, EVA, Teflon, Foil) are excellent for freezing cells and tissues at various temperatures.
Aseptic Filling: Gain efficiency and reduce contamination by incorporating ASI’s aseptic filling connector into your product and process. The filling connector works with ASI’s Single-Use Aseptic Filling
System to allow sterile transfer of fluids in a clean room or laminar flow hood.
CONSISTENCY AND RELIABILITY
Our ERP System is the Device Master Record and Device History Record for the 4,500 products that we manufacture. This system
ensures that all components are lot traceable and consistently meet their specifications.