MVP™ Aseptic Manufacturing

services05Process quality by design

Innovating a high-precision unit dose delivery solution gave rise to the need for form/fill/seal process performance that vastly exceeds the performance required of most traditional form fill seal processes.

Some key characteristics of the patented MVP aseptic unit dose blister process:

  • Patented blister forming process yields a small packaged footprint.
  • Exacting process tolerances allow the blister to perform as a critical functional component in the controlled dispensing of drug product.
  • Innovative, High Efficiency Sealing keeps excess heat away from the drug or biologic, minimizing risk of thermal degradation during the packaging process.
  • High throughput rates enable MVP systems to be scaled to commercial volumes at reasonable cost.
  • High performance processes – selection and development of process technologies that comprise the MVP manufacturing platform took into consideration the demanding tolerances needed by the VersiDoser and VRx2 dispensing technologies. The result is highly capable processes. Time and money are not wasted attempting to “inspect in” the quality of the finished product.
  • Aseptic process – ensures that finished drug product will be sterile even if terminal sterilization is not possible due to sensitivity of the drug.
  • Intelligent inline process automation and inspection – Supports Quality By Design (QbD) initiative

Scalability

The MVP aseptic unit dose manufacturing process is designed for scalability and flexibility. Production components require very small footprint and therefore work well with the closed-barrier isolator design, even at scales approaching one million unit doses per day.

Flexibility

MVP process can be seamlessly integrated into downstream assembly and packaging. Alternatively, once the dose units are sealed, output can be securely stored as WIP at extremely high density without additional risk to product integrity. Production components can be introduced into the process presterilized. Alternatively, since the key packaging components are laminated films, they can be sterilized inline, reducing logistical costs and complexity.