Quality management is essential for pharmaceutical and biotec companies throughout the whole life cycle of a drug product. Contract development and manufacturing organizations (CDMOs) can support a drug product’s quality and effectiveness throughout the development and commercial manufacturing phase by supporting their clients with frequent stability studies.

Stability studies evaluate the quality of a drug product over a certain period in specific environmental circumstances and related to changes that occur throughout the development and commercialization process. These studies are used to determine both shelf life as well as storage conditions. They also help determine the packaging materials for the drug product for the production process. Drug products are often subject to natural and environmental factors at many times in the production and distribution process that could impact their quality and stability. As a standard best practice, stability studies should be performed during each stage of the product life cycle to guarantee the quality of the drug product by proving stability of the drug product’s fragile chemical composition. These studies are often time-consuming, but should be conducted frequently, and may be extensive depending on the drug product. However, stability studies ultimately prevent costly delays from arising later. Pharmaceutical service providers should build stability studies into the drug development timeline as well as into the commercial production phase at the onset to set expectations and account for this added time proactively, rather than reactively.

Prioritizing stability studies as an essential step in drug development

With each drug product comes its own challenges at various phases of the development and manufacturing process, and every drug product is bound to face several regulatory approvals. When drug developers submit drug products for approval, the submission must include data from stability studies for the drug substance and the final drug product. The stability studies confirm the quality of the drug substance or drug product and show if and how quality changes over time due to environmental conditions. Therefore, drug developers need to perform stability studies in almost every development and life cycle phase to analyze the product’s stability in various circumstances and provide the adequate data and documentation when it comes time for regulatory authorities to be involved.

Stability assessments are first conducted in the early stages of drug development. It continues with evaluating technical batches and clinical samples to find the proper formulation, primary containers, and production procedures befitting the maintenance of the drug formulations’ quality. In the later phases of drug development, stability studies continue with a different focus on creating expiration dates and acquiring market authorization. By performing stability studies throughout the drug development process, drug developers can immediately address any issues that may arise should testing show a decline in quality to prevent production and commercialization delays. Ultimately, this practice ensures that only good quality drug products will reach patients.

Although every drug product is unique in its chemical and physical properties and in its formulation, maintaining the stability of each drug product throughout the full development and product life cycle is essential. Because every product is different, drug developers and license holders need to conduct the right stability studies consistently. This is where a CDMO who specializes in a certain format, such as injectables, can serve as a valuable partner in identifying the best stability testing procedures for each phase.

Selecting the right stability study program for each drug product

There are several common types of stability assessments: real-time, accelerated, intermediate, and photostability. Real-time testing exposes a drug product to the temperature, humidity, and packaging storage conditions in which the drug is expected to be kept in the commercialization and distribution phases. Accelerated testing evaluates how a product reacts to more extreme conditions such as temperature and humidity to extrapolate long-term outcomes like determining shelf life and serves as supportive data for temperature excursions from labeled storage conditions. Intermediate testing is conducted alongside accelerated studies when a product shows potential for significant alteration after six months. Photostability testing analyzes how a drug is affected by exposure to light and ultraviolet radiation.

If the drug product passes stability studies each time they are conducted during the development phase, then it can move forward to the commercialization process. However, stability testing does not stop there. Even after a product launches, drug developers conduct stability studies regularly following initial commercialization of the product with additional studies required after post-approval changes.

Identifying the right stability testing strategy for each unique drug product is critical to maintaining product quality. Drug products can vary widely, from molecule size to complexity, sensitivity, manufacturing process, and more. A simple, small-molecule oral drug is vastly different from a complex large-molecule injectable and thus should be treated accordingly in stability testing. As each drug product evolves throughout the development process, the best-suited stability study approach may be readjusted to address all quality needs.

Achieving industry quality standards

Current Good Manufacturing Practice (cGMP) is a key component of the pharmaceutical and biotech industry and outlines the requirements necessary for maintaining the quality of drug products and active ingredients. Regulators require stability testing to comply with its guidelines, which are developed with quality assurance in mind. Drug developers are expected to provide written stability study protocols that outline specific information like storage conditions, validated test methods, specifications, test frequency, sample size, and more. Fortunately, most of the guidelines for stability studies in the biopharma industry are parallel across the board and well understood by CDMOs.

Although stability studies must be conducted by pharmaceutical and biotech companies, it can be a daunting task. The growing complexity of global regulations for quality assurance has led to an increasing demand for stability testing support within the industry. Instead of struggling to meet these regulatory challenges, many companies choose to collaborate with a CDMO to leverage their stability study knowledge. Outsourcing partners often have the qualified storage capacity and analytical laboratories as well as the expertise to perform proper stability studies that in-house facilities and personnel lack.

As the importance of stability assessments rises, drug developers as well as CDMOs face increased pressure to meet stricter regulatory expectations. With global standardization and the improvement of stability study strategies, they can meet regulations through stability studies to provide highest quality products to customers and their patients worldwide.