Advanced Aseptic Processing



ADVASEPT® Vial

Glass free vials as a proven container closure for biologics

ADVASEPT-Vials_medium

Innovative glass free vials:

  • Standard container sizes of 10ml, 50ml, and 100ml
  • Providing the tooling expertise to give container design freedom for multiple sizes
  • Reliable and efficient alternative for the Aseptic filling of IV Bags
  • Proven technology for biologics

The innovative glass free injectables platform leverages the advanced aseptic process of blow-fill-seal coupled with the automated stopper insertion process. The process minimize variables and the footprint compared to traditional aseptic vial filling.

A Proven Container Closure for Biologics

The goal of the experiment was two fold:

  • Does the heat of the vial formation impact the molecule?
  • How will the material perform in plastic vs. glass?

Case Study

  • Fill a monoclonal antibody (mAb) into the ADVASEPT® 10ml vial
  • Conduct a battery of analytical test to compare bulk mAb to mAb filled in ADVASEPT® vials to ensure the process does not embark any negative effects on the mAb
  • 16 total tests including SEC, SDS, cIEF
  • Fill glass vials with the same mAb and compare to the mAb filled in the ADVASEPT® vials over time across the same tests including activity

Does the heat of the ADVASEPT® vial formation impact the molecule?

Data from stability indicating parameters between the bulk mAb, glass vial and ADVASEPT®  vial drug product indicates that the blow-fill-seal process is amenable to biologics.

HPLC Expansion Analysis

How will the material perform in plastic vs. glass?

These studies confirm no significant differences were identified between glass and ADVASEPT® vials over the 9 months analyzed and begins to addresses the general requirements of safety and efficacy of the product in the container closure.

Dose Response Curve for model mAb

Bag Replacement Technology

Excellent alternative to traditional aseptic filling of bags and bottles to capture the trend of ready-to-use premixes in the primary care environment

  • Advanced aseptic process that reduces particulates.
  • Efficient manufacturing process.
  • Spacing saving potential in pyxis machines compared to bags.
  • Lower weight compared to glass vials.
  • Large volume container potential.
Container Design Freedom

ADVASEPT® technology offers unlimited potential with an endless number of possibilities, configurations and combinations

  • Customizable & flexible delivery solutions with the sterility assurance of this advanced aseptic process.
  • Functionality can be added directly into the container with aseptic assurance provided by Catalent’s blow-fill-seal technology.
  • Design expertise can provide the features desired in an efficient manufacturing solution.

Our expertise in the blow-fill-seal technology and in-house mold design capabilities can deliver unique primary container designs to provide your brand promise.