US 2022/0087900 A1 · POLYMER PROCESS BAGS AND METHODS FOR MANUFACTURING THE SAME

Abstract

A pharmaceutical package comprises a polymeric wall having an interior surface and an outer surface; and a tie coating of SiOxCy and/or a barrier coating of SiOx and/or a protective coating of SiOxCy on the interior surface. The walls may be formed into the vessel by means of laser welding. The package can be, for example, a rigid container, a bioprocessing bag or a transfer bag, wherein the coatings afford improved barrier properties and/or are effective to block extractables/leachables from the substrate and any coatings thereon and the coatings are able to maintain their desirable characteristics described herein against stretching/elongation conditions. The bag or rigid container can be used in the entire process of the CAR T cell manufacture/therapy. A method of handling the coated packages comprises limiting stretching the packages. The method of monitoring or controlling the internal pressure of the coated packages is also described.

Claims34

Dependent claims

A pharmaceutical package or vessel capable of use in CAR-T cell therapy, comprising:

a polymeric wall comprising an interior surface and an outer surface;
a tie coating or layer of SiOxCy, wherein x is from about 0.5 to about 2.4 and y is from about 0.6 to about 3, on the interior surface of the polymeric wall;
and/or
a barrier coating or layer of SiOx, wherein x is from 1.5 to 2.9, on the interior surface of the polymeric wall, or when present, the tie coating or layer of SiOxCy;
and/or
a passivation coating or layer or pH protective coating or layer of SiOxCy or SiNxCy, wherein x is from about 0.5 to about 2.4 and y is from about 0.6 to about 3, on the interior surface of the polymeric wall or, when present, on the innermost surface of the tie coating or layer or the barrier coating or layer;
and/or optionally
a surface layer or coating of any of, or combination of, the following:
silicon-based barrier coating system;
amorphous carbon coating;
fluorocarbon coating;
direct fluorination;
anti scratch/anti static coating;
antistatic coating;
antistatic additive compound in polymer;
oxygen scavenging additive compound in polymer;
colorant additive compound in polymer;
or antioxidation additive compound in polymer,
on any of the interior surface of the polymeric wall or, when present, the inner surface of any of the other coatings or layers.

16 more elements

Dependencies are inferred from the claim text.

Polymer process bags and methods for manufacturing the same

Life of this patent

Polymer process bags and methods for manufacturing the same

Life of this patent

Abstract

Claims34