5 Common Questions Related To Stability And Storage

One of the most crucial and vital aspects of biopharmaceutical development and manufacturing is Drug Stability. Millions of dollars and a whole lot is put on the line for the company involved with even the smallest mishaps. Owing to the importance of this critical facet, Stability Studies are conducted during various stages of development to ensure that the drug remains safe and potent after it exits the manufacturing facility. Listed below are a few common tests along with a brief explanation. 

1. Real-time Stability Test Conditions

Real-time stability tests are considered the best way to determine the shelf life of the drug. They often span for a time period of about two years. Pharmaceutical companies perform these tests at room temperature, under natural light and an expected level of humidity. These tests are performed periodically until the drug fails.

2. Accelerated Stability Test Condition

In this type of stability study, the drugs are subject to stress at a higher temperature, ideally about 50°C, with controlled humidity and pH levels, for a shorter period of time. The test takes into account degradation rates at different storage conditions and uses predictive analysis to establish a relation. Generally, both real-time stability test and accelerated stability tests are used for assessing the shelf life of the product. However, most prefer the accelerated test as a temporary measure to expedite the process.

3. Forced Degradation Testing

Forced degradation tests are performed on new drug substances and are subjected to conditions that are harsher than what is used in accelerated stability tests. These tests help in understanding the chemical reaction of molecules under various circumstances and also establishes degradation pathways of the new drug substance. This information is quite crucial in the development, formulation, and packaging stage. ICH guidelines for forced degradation testing is generic with no details about its practical approach. And while it is considered an important regulatory practice, it is not necessary for the formal stability study.

4. Requirement of Lots

A common query that often comes up with stability tests is the number of lots that are required. According to the ICH guidelines (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use), a minimum of three lots are needed. However, the number might vary depending on multiple factors. Hence, the best way to find out the requirement of lots is by consulting regulatory authorities or employing services of a professional manufacturing & development biopharmaceutical organization.

5. Container and Closure Integrity Testing

Container and Closure integrity Testing (CCIT) is an assay or a test that helps determine the adequacy of the containers closure systems to ensure that the sterility and quality of the pharmaceutical product is maintained throughout its shelf life. Container closure systems essentially consist of primary and secondary packing components. Primary components are products that come in direct contact with the product (glass vials, syringes) while the secondary components ensure proper package assembly (stoppers and aluminium caps).

According to Statistics, in the year 2016, approximately 157 billion US dollars was spent by the Pharma industry only on research and development. These numbers are expected to cross over 180 billion US dollars by 2020. With high investments come the cost of associated risks. No product can go from the manufacturing lab to retail shelves unless it passes a series of stability studies within the defined protocol. Many pharmaceutical brands use the services of professional biopharmaceutical developers and manufacturers such as Kemwell for cost-effective solutions, backed by decades of expertise. 

For more, visit http://www.kemwellbiopharma.com