Container for a solution of human plasma proteins and method for obtaining thereof
Inventors
ROURA FERNANDEZ, CARLOS • GARCIA GARCIA, JOSE ANTONIO • LLORENS MASAS, Estela • MARZO ADAM, Nuria
Assignees
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Publication Number
US-10624814-B2
Publication Date
2020-04-21
Expiration Date
Abstract
A container for a solution of human plasma proteins has a primary inner bag made up of a first multilayer polymer film with two outer layers of polyethylene (PE) and an intermediate layer of ethylene vinyl alcohol (EVOH) copolymer, and a secondary outer bag made up of a second multilayer film with layers of polyethylene terephthalate (PET)-silicon oxides (SiOx), oriented polyamide (OPA), polypropylene (PP)-silicon oxides (SiOx) and polypropylene (PP), referred to as multilayer PP-SiOx.
Core Innovation
The invention relates to a container for a solution of human plasma proteins that uses a primary inner bag and a secondary outer bag with specific multilayer polymer films. The solution of human plasma proteins is contained within the primary inner bag made from a first multilayer polymer film comprising two outer layers of polyethylene (PE) and an intermediate layer of ethylene vinyl alcohol (EVOH) copolymer.
The container further includes a secondary outer bag formed from a second multilayer polymer film comprising layers of polyethylene terephthalate (PET)-silicon oxides (SiOx), oriented polyamide (OPA), polypropylene (PP)-silicon oxides (SiOx) and polypropylene (PP). In this configuration, the secondary outer bag is designed to significantly reduce a weight loss of the container.
The document reports that the container provides stability for human plasma proteins, including albumin solutions and immunoglobulins. Immunoglobulin stability is compared versus glass vials using appearance, pH, turbidity, osmolality, molecular distribution, and weight loss, and color stability is reported through comparable optical density.
Claims Coverage
The independent claim covers a container architecture defined by a primary inner bag multilayer film (PE/EVOH/PE) plus a secondary outer bag multilayer film (PET-SiOx/OPA/PP-SiOx/PP), with the solution contained in the primary inner bag and a significant reduction in container weight loss. The claim set also includes hermetic inlet cap closure by welding, a peelable secondary outer bag, and specified human plasma proteins.
Primary inner bag multilayer film for containing human plasma proteins
A primary inner bag comprising sheets of a first multilayer polymer film comprising two outer layers of polyethylene (PE) and an intermediate layer of ethylene vinyl alcohol (EVOH) copolymer.
Secondary outer bag multilayer film with SiOx layers to reduce weight loss
A secondary outer bag comprising a second multilayer polymer film comprising layers of polyethylene terephthalate (PET)-silicon oxides (SiOx), oriented polyamide (OPA), polypropylene (PP)-silicon oxides (SiOx) and polypropylene (PP), wherein the solution of human plasma proteins is contained within the primary inner bag and wherein a weight loss of the container is significantly reduced.
Hermetic inlet cap closure by welding
A container in which the inlet cap structure is hermetically closed either reversibly or irreversibly by welding.
Peelable secondary outer bag
The container includes a secondary outer bag configured to be peelable.
Container for specified human plasma proteins
A specified container that contains a primary inner bag holding human plasma proteins from human plasma including albumin, α-1-antitrypsin, von Willebrand factor, coagulation factors (factor VII, factor VIII, and factor IX), immunoglobulins, plasminogen, plasmin, antithrombin III, fibrinogen, fibrin, thrombin, or combinations thereof.
Overall, the claim set centers on a two-bag container structure: a primary inner bag of PE/EVOH/PE multilayer film and a secondary outer bag of PET-SiOx/OPA/PP-SiOx/PP multilayer film, with hermetic inlet closure by welding and, in some embodiments, a peelable secondary outer bag. The container is configured to significantly reduce container weight loss while supporting stability of solutions of human plasma proteins.
Stated Advantages
A weight loss of the container is significantly reduced.
Immunoglobulins meet pharmacopoeia specifications when stored in the container.
Color stability is comparable to that of glass vials as shown by comparable optical density (OD).
Immunoglobulin stability is comparable versus glass vials, including appearance, pH, turbidity, osmolality, molecular distribution, and weight loss.
Documented Applications
Storing solutions of human plasma proteins, including albumin solutions and immunoglobulins, in a container using a primary inner bag and a secondary outer bag with specified multilayer polymer films.
Comparison of container stability for immunoglobulins versus glass vials under accelerated and refrigerated conditions, including compliance with European Pharmacopoeia and United States Pharmacopoeia specifications.
Color stability evaluation via optical density (OD 350–500 nm) for multilayer PP-SiOx container versus glass vials.
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