Administration devices management for biological products: a real challenge

A smart approach for in-use stability and compatibility study and using an integrated risk-based approach as guarantee of quality and safety.

Administration devices play a vital role in the development, delivery, and administration of biological products. A risk-based approach to managing these devices ensures product quality and safety, which is crucial due to the complexity and sensitivity of biological therapies.

Biological products are prepared and administered through various routes, often involving different devices. With multiple clinical sites involved in clinical trials, these sites may use a range of devices, complicating the control of administration protocols for the sponsor. Moreover, no standardized guidelines exist for controlling the medical devices involved in the preparation and administration of biological products. The risks associated with these devices include product degradation or adsorption, which could compromise patient safety and affect clinical trial outcomes. To address this, Inits developed a comprehensive process to manage, document, and justify the use of each device reference in clinical trials.

This process follows four key steps:

Defining the administration protocol and selecting appropriate devices
Designing the in-use study
Conducting the in-use study and reporting results
Implementing a risk-based approach to approve clinical site devices.

A risk-based approach involves identifying, evaluating, and mitigating potential risks associated with the use of devices. This method helps sponsors streamline the management of administration devices and reduce complications.

The design of the in-use study is crucial for ensuring that the biological product is compatible with the selected preparation and administration devices. To address potential challenges during product preparation and injection, the study is designed using worst-case parameters such as preparation duration, holding time, injection time, surface-to-volume ratio, and length. This helps prevent unforeseen events from jeopardizing patient safety or the effectiveness of the treatment.

Upon completing the in-use study, some clinical sites may request the use of their own devices, which may not have been tested. In such cases, a risk assessment is conducted to justify the use of these new devices, focusing on their potential impact on patient safety and product efficacy. This assessment follows a structured protocol, involving a matrix scoring system. The conclusion is then recorded in a memorandum.

The risk assessment takes into account various characteristics of the device, such as its composition, size, length, surface-to-volume ratio, and type of connection. Each parameter is evaluated for its potential impact, with risks categorized as low, medium, or high. The total risk score helps determine whether the device can be safely used or should be rejected due to potential risks to patient safety or product efficacy.

Inits offers pharmaceutical and biotech companies a complete solution for designing in-use studies, controlling preparation and administration devices for biological products to ensure a safer and more efficient devices management during all the clinical trial phases.

By Laura GIERSCH and Anne DIEDERICHS, CMC and Technical Consultants at INITS

Our poster is available in PDF format upon request! Contact us at hello@inits.fr

A smart approach for in-use stability and compatibility study and using an integrated risk-based approach as guarantee of quality and safety.

Administration devices play a vital role in the development, delivery, and administration of biological products. A risk-based approach to managing these devices ensures product quality and safety, which is crucial due to the complexity and sensitivity of biological therapies.

Biological products are prepared and administered through various routes, often involving different devices. With multiple clinical sites involved in clinical trials, these sites may use a range of devices, complicating the control of administration protocols for the sponsor. Moreover, no standardized guidelines exist for controlling the medical devices involved in the preparation and administration of biological products. The risks associated with these devices include product degradation or adsorption, which could compromise patient safety and affect clinical trial outcomes. To address this, Inits developed a comprehensive process to manage, document, and justify the use of each device reference in clinical trials.

This process follows four key steps:

Defining the administration protocol and selecting appropriate devices
Designing the in-use study
Conducting the in-use study and reporting results
Implementing a risk-based approach to approve clinical site devices.

A risk-based approach involves identifying, evaluating, and mitigating potential risks associated with the use of devices. This method helps sponsors streamline the management of administration devices and reduce complications.

The design of the in-use study is crucial for ensuring that the biological product is compatible with the selected preparation and administration devices. To address potential challenges during product preparation and injection, the study is designed using worst-case parameters such as preparation duration, holding time, injection time, surface-to-volume ratio, and length. This helps prevent unforeseen events from jeopardizing patient safety or the effectiveness of the treatment.

Upon completing the in-use study, some clinical sites may request the use of their own devices, which may not have been tested. In such cases, a risk assessment is conducted to justify the use of these new devices, focusing on their potential impact on patient safety and product efficacy. This assessment follows a structured protocol, involving a matrix scoring system. The conclusion is then recorded in a memorandum.

The risk assessment takes into account various characteristics of the device, such as its composition, size, length, surface-to-volume ratio, and type of connection. Each parameter is evaluated for its potential impact, with risks categorized as low, medium, or high. The total risk score helps determine whether the device can be safely used or should be rejected due to potential risks to patient safety or product efficacy.

Inits offers pharmaceutical and biotech companies a complete solution for designing in-use studies, controlling preparation and administration devices for biological products to ensure a safer and more efficient devices management during all the clinical trial phases.

By Laura GIERSCH and Anne DIEDERICHS, CMC and Technical Consultants at INITS

Our poster is available in PDF format upon request! Contact us at hello@inits.fr

A smart approach for in-use stability and compatibility study and using an integrated risk-based approach as guarantee of quality and safety.

Administration devices play a vital role in the development, delivery, and administration of biological products. A risk-based approach to managing these devices ensures product quality and safety, which is crucial due to the complexity and sensitivity of biological therapies.

Biological products are prepared and administered through various routes, often involving different devices. With multiple clinical sites involved in clinical trials, these sites may use a range of devices, complicating the control of administration protocols for the sponsor. Moreover, no standardized guidelines exist for controlling the medical devices involved in the preparation and administration of biological products. The risks associated with these devices include product degradation or adsorption, which could compromise patient safety and affect clinical trial outcomes. To address this, Inits developed a comprehensive process to manage, document, and justify the use of each device reference in clinical trials.

This process follows four key steps:

Defining the administration protocol and selecting appropriate devices
Designing the in-use study
Conducting the in-use study and reporting results
Implementing a risk-based approach to approve clinical site devices.

A risk-based approach involves identifying, evaluating, and mitigating potential risks associated with the use of devices. This method helps sponsors streamline the management of administration devices and reduce complications.

The design of the in-use study is crucial for ensuring that the biological product is compatible with the selected preparation and administration devices. To address potential challenges during product preparation and injection, the study is designed using worst-case parameters such as preparation duration, holding time, injection time, surface-to-volume ratio, and length. This helps prevent unforeseen events from jeopardizing patient safety or the effectiveness of the treatment.

Upon completing the in-use study, some clinical sites may request the use of their own devices, which may not have been tested. In such cases, a risk assessment is conducted to justify the use of these new devices, focusing on their potential impact on patient safety and product efficacy. This assessment follows a structured protocol, involving a matrix scoring system. The conclusion is then recorded in a memorandum.

The risk assessment takes into account various characteristics of the device, such as its composition, size, length, surface-to-volume ratio, and type of connection. Each parameter is evaluated for its potential impact, with risks categorized as low, medium, or high. The total risk score helps determine whether the device can be safely used or should be rejected due to potential risks to patient safety or product efficacy.

Inits offers pharmaceutical and biotech companies a complete solution for designing in-use studies, controlling preparation and administration devices for biological products to ensure a safer and more efficient devices management during all the clinical trial phases.

By Laura GIERSCH and Anne DIEDERICHS, CMC and Technical Consultants at INITS

Our poster is available in PDF format upon request! Contact us at hello@inits.fr