Kindra Whitlatch, Product Applications Manager at ThermoFisher Scientific, Shares Insights on Drug Stability Testing

Shots:

Kindra talked about the stability testing process and its applications in the pharmaceutical industry
She also spoke about the different important parameters for stability testing and the challenges faced during this process
The interview gives a deep understanding of ThermoFisher is supporting pharmaceutical and biopharmaceutical manufacturers in the drug stability testing process

Smriti: Please discuss stability testing in pharmaceuticals.

Kindra Whitlatch: Stability testing is a critical step in pharmaceutical R&D and quality control, encompassing everything from raw material experimentation to finished and packaged pharmaceutical product verification. Proper stability testing ultimately ensures that a drug product’s quality, safety, and efficacy won’t be affected, provided that the appropriate packaging is used, and recommended storage conditions are followed.

Pharmaceuticals are tested in accordance with established guidelines by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) section Q1A (R2) and the World Health Organization (WHO) by climate zone. These guidelines ensure that sufficient testing is completed to protect product quality.

Stability testing differs based on the formulation stage of the product. For example, pre-market stability testing supports the clinical trial and filing period during which active ingredients and formulated drug products are tested under varying conditions to evaluate safety and efficacy over time. Once the drug product has reached its final formulation, stability testing is used to assess the impact of packaging on a drug’s strength, quality, purity, and safety to determine the most effective packaging method. This guarantees the safety of drug products and that they won’t degrade during the distribution cycle from transport to storage.

Last, shelf-life stability testing determines the duration a drug may be stored under recommended conditions while remaining suitable for sale and safe for consumption. It also helps determine the expiration date of products. Shelf-life stability is often conducted on an accelerated timetable and at elevated environmental conditions to reduce the time needed to complete a testing cycle.

Smriti: Why is there a need for product stability testing?

Kindra Whitlatch: Drug products are manufactured with great care to have an exact set of properties and characteristics for intended use, making it critical that these properties are retained from the time they are formulated until the time they are consumed. Stability testing ensures that variable parameters, such as light, temperature, humidity, and pH do not negatively impact a drug product’s efficacy or safety before it reaches the consumer.

Smriti: List the challenges industry stakeholders face during the stability testing process.

Kindra Whitlatch: Stability studies require careful planning at an early development stage to meet regulatory expectations. Some common challenges include:

Selecting and validating the right test. Many labs conduct more stability studies than necessary to avoid regulatory questions, while others may perform insufficient stability work to speed the timeline – but both can impact the drug development process timeline and long-term efficacy.
Assessing a biologic’s stability. The rise of newer, large-molecule drug products developed using biotechnology has brought about new scientific challenges, as the typical small molecule stability study conditions are unsuitable for large molecule drugs.
Planning appropriate testing timelines. Sufficient time to dedicate to stability testing can be hard to find in development timelines, particularly in the case of shelf-life testing. To satisfy testing requirements in a timely manner, accelerated testing has been widely adopted, which requires testing to be completed under more extreme conditions to simulate degradation time at recommended storage conditions.

Smriti: What are the parameters that the industry is using in stability testing?

Kindra Whitlatch: Primary stability testing parameters include temperature, pH, humidity, and light.

Temperature is one of the most crucial factors in drug stability because physicochemical stability is only ideal within a narrow range. In fact, an increase of about 10°C in storage temperature can accelerate hydrolytic degradation by up to 500%.
pH, much like temperature, is a factor that affects the stability of a drug prone to hydrolytic decomposition. A change in a drug product’s pH is an indicator that it is undergoing changes that could alter its safety and potency.
Humidity is a key factor in establishing the potential degradants in a finished product and in active pharmaceutical ingredients. For establishing forced degradation samples, ICH guidelines recommend 90% humidity for a one-week period.
Light may cause chemical instability (for example phototoxicity, photoallergy, and photosensitization) in photosensitive molecules, which makes controlling light in the testing environment imperative.

Smriti: Put a glimpse on ‘Stress Testing. How is it useful in efficiency and standards improvement and minimizing the need for stability testing?

Kindra Whitlatch: Stress testing has become increasingly common as more pharmaceutical manufacturers work to improve efficiency and elevate their standards. The purpose of stress testing is to create extreme environmental conditions in the lab to emulate multiple climate zones and conditions to which a drug product may be subjected. The knowledge gained from stress tests is invaluable for high-quality formulation development, packaging design, and establishing storage standards.

Smriti: Would you like to give any suggestions to the researchers about parameters and design that should be considered in stability testing?

Kindra Whitlatch: N/A - Pharmaceuticals are tested in accordance with established guidelines by ICH, WHO, and other regulatory bodies.

Smriti: What does Thermo Fisher Scientific offer to support stability testing?

Kindra Whitlatch: Thermo Fisher Scientific offers environmental and light chambers to help pharmaceutical and biopharmaceutical manufacturers achieve testing consistency and regulatory compliance through forced degradation testing.

The Thermo Scientific™ Forma™ Environmental Chamber provides a temperature and humidity-controlled enclosure to test the effects of specified environmental conditions. Complete with a horizontal airflow system, wide temperature range, and relative humidity controls, the Forma Environmental Chamber is ICH compliant. Constructed of stainless steel and available in a variety of sizes and configurations, the Forma environmental chamber provides the versatility and flexibility required to accommodate a multitude of testing requirements.

The Thermo Scientific™ Forma™ Light Chamber is a controlled enclosure used to simulate the effects of light, temperature, and humidity. Comprised of seven (7) modular light bulbs designed to simulate illumination and UV exposure, the Forma light chamber is ICH compliant. A horizontal airflow system maintains temperature uniformity and stability, while a flexible lighting configuration ensures testing requirements are met. Available in a variety of sizes and configurations, the Forma Light Chamber provides flexibility and usability to accommodate a variety of testing requirements.

Source: Canva

About the Author:

Kindra Whitlatch is the Product Applications Manager at Thermo Fisher Scientific. She provides subject matter expertise supporting the use of Environmental Chambers, Microbiological Incubators, Drying Ovens, Vacuum Ovens, and Furnaces in the laboratory setting. Kindra specializes in the use of equipment in the life science laboratory and is responsible for training and supporting colleagues and customers in the appropriate use of the products she supports. She holds an MS in Molecular Biophysics and Structural Biology from the University of Pittsburg School of Medicine and a BS in Chemistry from West Virginia Wesleyan College.