US-20260125629-A1 - SYSTEM FOR USE IN BIOPROCESSING

US20260125629A1US 20260125629 A1US20260125629 A1US 20260125629A1US-20260125629-A1

Abstract

A consumable container for filling with a fluid in a bioprocessing process. The container comprises one or more sealable, removable portions, such that one or more samples of the fluid may be taken by sealing and removing one or more of said portions.

Inventors

Edwin Stone
Peter Crossley

Assignees

Cellular Origins Limited

Dates

Publication Date: 20260507
Application Date: 20251103
Priority Date: 20160524

Claims (1)

1 . A consumable container for filling with a fluid in a bioprocessing process, comprising: one or more sealable, removable portions, such that one or more samples of the fluid may be taken by sealing and removing one or more of said portions.

Description

RELATED APPLICATIONS The present application is a continuation patent application of Ser. No. 17/568,054, filed Jan. 4, 2022, which is a continuation patent application of Ser. No. 16/302,304, filed Nov. 16, 2018, which is a national stage application under 35 U.S.C. § 371 of International Application No. PCT/GB2017/051459, filed 24 May 2017, which claims priority to Great Britain Patent Application No. 1609084.7, filed 24 May 2016. The above referenced applications are hereby incorporated by reference into the present application in their entirety. FIELD The present invention relates to a system for use in bioprocessing. BACKGROUND In bioprocessing it is often necessary to remove a sample from a larger volume of a product, such as for analysis of the sample for the purpose of quality assurance. Because of the nature of such bioprocessing, several design constraints are imposed on systems for removing such samples. For example, the removal of samples must be carefully controlled to avoid modifying or damaging the samples, and the samples must be of a minimum possible volume to avoid wasting potentially expensive product. Furthermore, such systems should be structured so that the process is aseptic, to avoid contamination of the product or samples. Many areas of biological research, for example autologous cell therapies, can also require that samples be taken at specific times, and that any samples be traceable. Variation in timing compared to the expected timing will lead to uncertainty over the validity of the result. For example, in a cell expansion process, taking a sample late could lead an incorrect assessment of the rate of expansion. A failure to ensure traceability could lead to analysing an incorrect sample. In the worst case this could lead to an unsafe product being declared safe. It is also desirable that such a system be low cost. Developing such systems therefore presents many challenges, and currently, therefore, sampling is often done manually. One example of a manual process of removing a sample from a larger volume of a product relates to the removal of a sample from a WAVE Bioreactor, as produced by GE Healthcare Life Sciences. In such bioreactors a product is held within a disposable bag and rocked to provide mixing and gas transfer. When a sample is taken the movement of the product must be stopped and the user must prepare a sample port, for example by wiping with alcohol. The user must then connect a syringe to the sample port and tip the product bag so that the sample may be aspirated into the syringe. The movement of the product may only be restarted after the syringe has been removed. Finally, the sample must be transferred from the syringe into a format suitable for processing in an analysis system, for example a vial. Such a manual process has numerous drawbacks, however. The first of these is that, in order for a sample to be taken, the product movement must be stopped, and this interruption will be for a variable period of time, potentially leading to product variability. There are also issues with the sampling method itself not being completely closed or completely controlled. As mentioned above, it is important to ensure that the sample and product are not contaminated and that they are not damaged. However, the interface between the syringe and the product is not completely sealed, leading to potential contamination, and the aspiration is not completely controlled, potentially leading to damage of the product and sample. There is also the issue that the sample volume may be larger than necessary. Additionally, the timing of the sampling is dependent on the user as the process is highly user intensive. The present invention aims to solve this and other issues by providing a means of taking samples of a product which is easily automated and which is resistant to damage or contamination of the product and sample and allows for reliable traceability. A further problem is that once the sample is taken it needs to be analysed. Common analyses can include cell viability and cell counting through first staining the cells and then imaging using an appropriate system. Other analytical approaches will look at cell phenotype using a fluorescent label and a flow cytometer. Further they can include molecular analysis, studying a cell's DNA with PCR, or alternatively a biomarker such as protein expression by the cells by using an immuno-assay. Other assays can look for contamination such as bacterial, fungal, or viral. Typically a sample is taken from a bioreactor, transported to an area appropriate for sample preparation and then moved on for subsequent analysis. When working with biological samples, this will typically require biological containment to both protect the operator and to ensure the sample is not contaminated. There is variability and cost associated with both the sample transport and the analysis of the sample due to the operator involvement. The need for containment also p