iSpeak Blog

Lean Stability Strategies and Best Practices Discussed during Webinar

Nicholas Fico, PhD
Roujian Zhang, PhD
Roundtable Discussion – Lean Stability

Stability sampling and testing are key to ensuring that products maintain safety, identity, strength, purity, and quality throughout their claimed shelf life. It is also a regulatory requirement per ICH Q5. However, storing product samples in different environmental conditions, testing those samples for three to five years (or more) after initial manufacture, and properly analyzing and reporting the data generated can be expensive and time-consuming. In this webinar, “Roundtable Discussion – Lean Stability,” industry leaders discussed strategies and best practices to meet the expectations of regulatory agencies and patients, while minimizing cost to the business.

Brandy Berry, Program Manager for ISPE opened the webinar. The speakers included Gottfried Stubauer, Global Head of Quality Control/Analytical Science and Technology for Sandoz; Deanna Hurum, Director in Analytical Science for Genentech; and Deanna Hurum, Director Quality Systems for Evive Biotechnology.

Gottfried Stubauer
Global Head QC / Analytical Sciences & Technology

Gottfried Stubauer led the discussion on lean stability by sharing his learnings and experiences at Sandoz. Sandoz is one of the largest generic pharma companies with over 11,000 ongoing stability studies, so even small improvements can result in large savings of time and money. One early takeaway from Gottfried’s talk was that on average 20-30 percent of all drug substance/drug product (DS/DP) testing is for stability. Therefore, simplification of stability studies can have a measurable impact on the efficiency of the entire quality unit and not just the stability team.

For Stubauer, lean stability for new products starts with a strong understanding of the regulations and a strong understanding of the science. He shared many strategies for reducing testing, including only selecting stability-indicating parameters and allowing bracketing (only testing extremes of storage conditions and DP strengths). For legacy products, ongoing stability studies are reviewed against best practices to identify time and cost-saving opportunities. For this to work, strong coordination across sites and business units is a must. Stubauer’s key recommendations were to maintain a collection of best practices, have regulatory and stability experts define stability programs together, and use templates for justifications of changes to help facilitate discussions and decision-making.

Deanna Hurum

Hurum led the follow-up discussion. She shared her learnings from applying lean principles at Genentech. Applying lean principles resulted in a one-time savings of $5.6 million USD and additional yearly savings by improving stability testing strategies. Hurum shared many strategies for efficiency by looking at both the stability programs and lab testing. Savings for stability programs came from reducing methods and time-points, where justified and with global health authority approval. Savings in the lab came from updating and harmonizing methods across products and sites, and from automating sample preparation. Hurum’s key takeaways were to provide a compelling rationale to manage risk, partner across departments, and use standardization to drive simplification.

Nicholas Fico, PhD
Director of Quality Systems
Evive Biotechnology

Lastly, Fico presented his experience and guidance for authoring and validating fully automated software for stability trending and reporting. The validated software is GMP compliant and resulted in a time savings of 3+ full time employees (FTE)/annually for a stability group of five people. The software generates a stability trending report, including a list of out-of-trend (OOT) time points, trend charts of selected test methods, and formatted stability data in about 90 seconds. Fico’s key takeaways were that having fully automated reporting software can be possible for a pharmaceutical company and that a carefully planned road map from software planning to GMP validation will yield savings at every step.

The webinar concluded with an open question-and-answer session between the listeners and the audience. A couple of audience members asked if the US Food and Drug Administration (US FDA) or other regulatory agency ever challenged the reduced testing strategies discussed in the webinar. Stubauer and Hurum shared that in their experience, well justified, scientifically sound proposals were accepted by regulatory authorities. Another audience member asked Stubauer if he could share an example of an actual bracketing protocol that was accepted by the US FDA. Stubauer responded that the US FDA had accepted stability protocols where only extremes of temperature and humidity storage conditions were routinely tested, e.g., 4°C and 37°C. Stability samples stored at intermediate conditions, such as 25°C, were only tested if needed to support an investigation. Finally, Stubauer asked Fico if it was possible to use the stability trending software to identify out of trend data points prior to quarterly reports. Fico confirmed that yes, as soon as data was approved in the laboratory information management (LIMS) system, the software could be used to pull the data and generate trend charts. In this way, the trending and reporting software was routinely used to monitor ongoing stability studies soon after testing was completed, as well as being used to support ongoing investigations.

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