Category: intelliFiller™

I-Fill Micro Pumps for Transporting Live Cells

INTELLITECH’S I-Fill Micro Pumps for transporting live cells have qualified, as a study in collaboration with the University of South Florida demonstrated that the I-Fill is a viable alternative to peristaltic pumps for live cell transport.

by Kadeja Johnson

Reprinted from Phacilitate.com

January 16, 2024

Intellitech’s i-FILL Pump Qualifies for Live Cell Transfer

Intellitech, a reliable partner for dispensing and filling applications, proudly unveiled the i-FILL pump as a groundbreaking alternative to peristaltic pumps for live cell transfer in the growing cell therapy market. Traditional straight peristaltic pumps have been associated with cell damage. Intellitech’s hybrid piston/diaphragm technology aims to provide superior accuracy, repeatability, control capability, and reduced stress on cells.

In a strategic collaboration with the University of South Florida, Intelli-TECH conducted a comprehensive cell viability study comparing the i-FILL pump to a convex roller peristaltic pump. The results of the study were showcased at the scientific poster zone at Advanced Therapies Week 2024.

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Ms. Olukemi Akintewe, Ph.D., Associate Professor at the University of South Florida, expressed that “Intellitech came to us because we had the resources and staff to perform the cell study. We looked at cell proliferation, adhesion, detachment and performed a live/dead cell assay for samples circulated through each pump for varying time periods.”

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i-Fill cell transfer — i-FILL® Transfer Pump

Known for precise and repeatable dispensing accuracy, the i-FILL family of pumps has now earned qualification for live cell transfer.

The study focused on evaluating the i-FILL Micro pumps for live cell transport, utilizing NIH-3t3 fibroblast cells in viability experiments. The experiments involved sample volume suspensions with a cell density of approximately 3.57 x 10⁵ cells/ml and a flow rate of 1.9 L/min at different sampling times (circulation) of 5, 20, and 60 minutes. Results demonstrated that the i-FILL is a viable alternative to peristaltic pumps for live cell transport.

Having served as a precision dispensing pump in drug product, media, and diagnostic reagent filling applications for over two decades, the i-FILL pump has now been proven to be a highly capable, low-shear live-cell transfer pump. It excels in critical applications where peristaltic pumps may be insufficient. The hybrid diaphragm/positive displacement pump offers precise control over dispensed volume, flow rate, acceleration, and deceleration, providing unmatched accuracy and repeatability. The materials in its single-use fluid path have been qualified for both cell suspensions and drug product applications.

Intellitech™ has broad experience providing a full spectrum offering of single use systems for various applications from development through full scale GMP production. We support customers with design, development, manufacture, assembly, packaging, post processing (gamma irradiation) as well as validation studies of single-use systems for package integrity, seal strength, shelf life, bio-burden, sterility and dose audits.

Call 727-202-6419 or email sales@intellitech-inc.com to discuss your project with one of the leading companies innovating single-use systems for the life science industry.

What are the steps to validate a single-use system in the production of cell and gene therapy?

Validating a single-use system in the production of cell and gene therapy is a crucial process that ensures the quality and safety of the final product. To accomplish this, a well-defined validation strategy needs to be established, identifying critical parameters that require validation such as material compatibility, extractables and leachables, and sterilization. The following are the steps that should be taken to validate a single-use system that will be used in development and/or production of a cell and gene therapy, biologic or pharmaceutical drug product.

Define the Validation Strategy:

The first step in validating a single-use system is to define the validation strategy. This involves identifying the critical parameters that need to be validated, such as material compatibility, extractables and leachables, sterilization, package integrity, and shelf life. Material compatibility refers to the ability of the single-use components to function correctly with the other components in the system without causing any adverse reactions or degradation. Extractables and leachables refer to any substances that may be released from the single-use components and may affect the safety or efficacy of the final product. Sterilization is a critical parameter that ensures the safety of the product. Package integrity relates to seal strength and the ability of the packaging to create a sterile barrier system (SBS) and protective packaging of the single-use system. Shelf life will include accelerated aging study and an actual shelf-life test to identify how long the product can be expected to perform as designed after manufacturing and post processing. The validation strategy should also define the acceptance criteria for each parameter. These acceptance criteria should be based on relevant regulatory requirements and industry standards.

Define the Validation Study:

The next step is to design the validation study. This involves developing detailed protocol(s) that outline the procedures for testing the critical parameters identified in the validation strategy. The protocol should be developed based on regulatory guidelines, industry standards and the intended use of the product. The protocol should include the sample size, test methods, and acceptance criteria. The sample size should be statistically significant to ensure that the results are representative of the entire batch or production process. The test methods should be scientifically sound and validated. The acceptance criteria should be established based on relevant regulations and industry standards such as USP, ISO and ASTM.

Execute the Validation Study:

Once the validation study protocol has been developed, the next step is to execute the study. This involves performing the tests outlined in the protocol and documenting the results. The execution of the study should be carefully planned and performed in accordance with the protocol. All deviations from the protocol should be documented, and corrective actions should be taken to address them. The study should be performed by trained personnel in a controlled environment to ensure accuracy and reproducibility of the results.

Analyze the Data:

After the validation study has been completed, the data should be analyzed to determine whether the single-use system meets the acceptance criteria defined in the validation strategy. The data analysis should be performed by trained personnel who are experienced in statistical analysis and data interpretation. The analysis should be performed using appropriate statistical methods and software. If the acceptance criteria are not met, further testing may be required, or the single-use system may need to be modified.

Document the Validation:

The final step in validating a single-use system is to document the validation. This involves preparing a validation report that summarizes the validation strategy, study protocol, test results, and analysis of the data. The report should also include any deviations and corrective actions taken during the validation study. The validation report should be comprehensive, accurate, and written in a clear and concise manner. It should be reviewed and approved by qualified personnel and should be maintained as a part of the product history record.

In Summary

In summary, validating a single-use system in the production of cell and gene therapy requires a well-defined validation strategy, a carefully developed validation study protocol, meticulous execution of the study, data analysis, and thorough documentation. Following these steps will ensure the quality and safety of the final product.

Intellitech has broad experience in the design, development, manufacture, packaging and validation of single-use systems, partnering with independent 3^rd party accredited laboratories to perform testing. We provide phase-appropriate validation studies to support customers from R&D to GMP.

Call 727-202-6419 or email sales@intellitech-inc.com to discuss your project with one of the leading companies innovating single-use systems for the life science industry.

2D and 3D Single-use Bag Assemblies Provide a Reliable and Efficient Process in the Development of Biologic and Pharmaceutical Drug Products or Cell and Gene Therapies

Single-use bag assemblies play a crucial role in the development of biologic and pharmaceutical drug products, as well as cell and gene therapies, which has revolutionized the healthcare industry in recent years. According to a report by Grand View Research, the global biopharmaceuticals market size was valued at $337.3 billion in 2020 and is expected to grow at a compound annual growth rate (CAGR) of 7.5% thru to 2028. These complex and sensitive products require a reliable and efficient manufacturing process. According to a survey by BioPlan Associates, over 85% of biopharmaceutical manufacturers use single-use technologies in their production process. These disposable containers are available in 2D and 3D configurations and offer several advantages over traditional, reusable containers, including reduced risk of contamination, scalability, and increased efficiency.

What are Single-Use Bag Assemblies?

Single-use bag assemblies are a type of disposable container that is used for the storage and transportation of biologic and pharmaceutical drug products, as well as cell and gene therapies. They are available in 2D (flat) and 3D configurations that offer several advantages over traditional, reusable containers.

2D and 3D Configuration Advantages

One of the key advantages of single-use bag assemblies is their ability to reduce the risk of contamination. A study published in the Journal of Pharmaceutical Sciences found that single-use bag assemblies reduced the risk of contamination by over 60% compared to traditional containers. Biologic and pharmaceutical drug products, as well as cell and gene therapies, are often produced using living organisms and are therefore subject to a higher risk of contamination compared to traditional small molecule drugs.

In addition, single-use bag assemblies can be pre-validated and used in a consistent manner, which helps to ensure that the storage and transportation processes are performed correctly and consistently. This consistency is critical for maintaining the quality and consistency of the final biologic or pharmaceutical drug product or cell and gene therapy.

The scalability of single-use bag assemblies is also a key advantage. They can be quickly connected to existing storage and transportation systems and can be scaled up or down as needed to meet changing production requirements. These characteristics make single-use bag assemblies well-suited to the development of biologic and pharmaceutical drug products, as well as cell and gene therapies.

Minimize Downtime and Increase Efficiency

Finally, the use of single-use bag assemblies helps to minimize downtime and increase production efficiency. A report by the BioPhorum Operations Group found that over 75% of biopharmaceutical companies reported that single-use bag assemblies reduced downtime and increased production efficiency. This is especially important in the biopharmaceutical industry, where the production of biologic and pharmaceutical drug products, as well as cell and gene therapies, is typically expensive and time-consuming.

Intellitech can provide 2D and 3D bags in both standard and custom designs with multiple port configurations, both for media/buffer storage, transfer and mixing.

In Conclusion

In conclusion, the use of 2D and 3D single-use bag assemblies is critical to the development of biologic and pharmaceutical drug products, as well as cell and gene therapies. They offer several key advantages, including reduced risk of contamination, consistency in storage and transportation processes, scalability, and increased efficiency, making them an indispensable tool in the production of these complex and sensitive products.

Call 727-202-6419 or email sales@intellitech-inc.com to discuss your project with one of the leading companies innovating single-use systems for the life science industry.