What are the latest trends and innovations in GMP stability and shelf life assessment?

Good Manufacturing Practice (GMP) is a set of standards and guidelines that ensure the quality, safety, and efficacy of pharmaceutical products. One of the key aspects of GMP is the stability and shelf life assessment of the products, which involves testing and monitoring their physical, chemical, and microbiological properties over time under different environmental conditions. Stability and shelf life assessment is crucial for determining the expiration date, storage conditions, and labeling of the products, as well as for evaluating any changes or degradation that may affect their performance or safety. In this article, we will explore some of the latest trends and innovations in GMP stability and shelf life assessment, and how they can benefit the pharmaceutical industry and the consumers.

1 Accelerated stability testing

Accelerated stability testing is a method of simulating the effects of long-term storage on the products by exposing them to higher temperatures, humidity, light, or other stress factors. This allows for faster and more efficient evaluation of the stability and shelf life of the products, as well as for identifying any potential failure modes or quality issues. Accelerated stability testing can also help in optimizing the formulation, packaging, and manufacturing processes of the products, as well as in supporting regulatory submissions and approvals.

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Moumita Bhattacharya

Matrix Team Leader | Cell and Gene Therapy | Innovating Biologics Drug Product Development | CMC Process Improvement
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The benefits of accelerated stability is modality dependent. Typically for mAbs and small molecules it can be used for investigations. For complex modalities such as viral vectors or delivery of products via LNP's, these conditions are often too aggressive for meaningful data. Using more process relevant stressors or a "light" version of accelerated stability for complex modalities builds a better data package and validates that the analytical tests are appropriate.

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Jaswinderjit Singh

Senior Operations Advisory and Training Coach
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Latest ICH guidelines must be followed for an acceptable stability report. Stability studies protocol must include specific guidelines for the target geography one intends to cover.

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Bruce Gardner

Aseptic Fill Consultant | Quality Oversight | Tech Transfer | Manufacturing Support | Process Development
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As temperatures and other stressors are increased, the activation energy may be reached for additional degradation pathways. As a result, accelerated stability testing should not be assumed to a good indicator of shelf life at normal storage temperatures. However accelerated stability may provide early insights into the impact of process changes.

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2 Real-time release testing

Real-time release testing is a method of assessing the quality and stability of the products based on the critical quality attributes (CQAs) that are measured or monitored during or immediately after the manufacturing process. This eliminates or reduces the need for traditional end-product testing, which can be time-consuming, costly, and labor-intensive. Real-time release testing can also enhance the traceability, consistency, and reliability of the products, as well as enable faster and more flexible responses to market demands and customer feedback.

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Gayatri Ganeshan

Analytical Lead for large molecule drug modalities
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Real time release testing offer more "realistic" scenario. Apart from just testing alone, some QbD approaches should be taken while choosing purposeful assays that shed more light on the attributes of the drug substance. This is especially more useful in the early stages of the development.

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3 QbD and PAT approaches

Quality by Design (QbD) and Process Analytical Technology (PAT) are two complementary approaches that aim to improve the quality and stability of the products by applying scientific knowledge, risk management, and continuous improvement throughout the product lifecycle. QbD involves designing the products and processes based on the intended performance and quality objectives, while PAT involves using advanced analytical tools and methods to monitor and control the processes in real time. Together, QbD and PAT can help in achieving better understanding, prediction, and control of the stability and shelf life of the products, as well as in reducing waste, variability, and deviations.

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Argus Sun

Bioengineer
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QbD and Lean Six Sigma are not mutually exclusive, Design of experiments can be effectively used as part of both approaches. As for process analyzers, it also depends on the product, oftentimes offline is still on-prem.

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4 Data analytics and modeling

Data analytics and modeling are methods of using statistical and computational techniques to collect, process, analyze, and interpret large and complex data sets related to the stability and shelf life of the products. These methods can help in identifying and quantifying the factors that influence the stability and shelf life of the products, as well as in developing and validating predictive models that can estimate the shelf life and stability profiles of the products under various conditions. Data analytics and modeling can also support decision making, risk assessment, and optimization of the stability and shelf life of the products.

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5 Novel delivery systems

Novel delivery systems are methods of designing and developing innovative ways of delivering the active ingredients of the products to the target site in the body, such as nanoparticles, micelles, liposomes, microspheres, or patches. These methods can enhance the bioavailability, efficacy, and safety of the products, as well as overcome some of the challenges and limitations of conventional delivery systems, such as low solubility, poor stability, or adverse effects. Novel delivery systems can also offer new opportunities for extending or improving the stability and shelf life of the products, as well as for creating novel formulations, combinations, or indications.

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Argus Sun

Bioengineer
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Cell-secreted nanoparticles are on the horizon towards becoming mainstays for drug delivery like liposomal or reservoir formulations. Improved targeting alongside immunoreactive advantages will ensure their place.

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6 Here’s what else to consider

This is a space to share examples, stories, or insights that don’t fit into any of the previous sections. What else would you like to add?

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What are the latest trends and innovations in GMP stability and shelf life assessment?

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1 Accelerated stability testing

2 Real-time release testing

3 QbD and PAT approaches

4 Data analytics and modeling

5 Novel delivery systems

6 Here’s what else to consider

GMP

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