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Editor of Pharmaceutical Technology Europe
Outsourcing stability testing to full-service providers can offer comprehensive benefits to bio/pharma companies.
Editor’s Note: This article was published in Pharmaceutical Technology Europe’s March 2020 supplement.
Stability testing is an essential and routine part of drug development, providing vital information on the stability of a drug formulation that is required by regulatory authorities worldwide. To perform these studies in-house can be challenging, both in terms of time and cost, particularly given the fact that the complexity of these analytical tasks is ever increasing.
“The demand for stability studies is constantly increasing due to rising complexity and global regulatory requirements,” asserts Karin Kottig, manager contract service analytics, Vetter Development Services. “By choosing an outsourcing partner, pharma and biotech companies can benefit from experts specialized in stability studies as well as available analytical equipment and qualified storage space.”
“Conducting an effective stability testing programme requires expertise in many fields, for example, specific analytical techniques, regulatory requirements, programme design, matrixing, logistics, and quality assurance,” says Ramesh Jagadeesan, senior director of analytical development, Recipharm. “Such programmes also require a considerable investment to set up the required stability chambers, validate the exact climate over time and in every part of the chamber, secure processes in events such as power failures or broken compressors, and to maintain them during the long assessment periods.”
As a result of the breadth of expertise and the significant amount of investment that can be required for effective stability testing, many bio/pharmaceutical companies have sought contract development and manufacturing organizations (CDMOs) to provide dedicated analytical services. “Partnering with a fullâservice provider offers comprehensive benefits as the services for production, release, and stability studies are combined under one roof and within one quality management programme,” notes Kottig.
Through performing stability programmes with a single service provider can not only streamline timelines but also processes, continues Kottig. “For example, a change in a release specification, which has to be implemented at the manufacturer and simultaneously at the stability testing side, is much easier when one company is used to achieve alignment,” she emphasizes.
For Jagadeesan, CDMOs are capable of providing access to the knowledge, resources, and technology required to perform stability studies, in addition to being able to generate the necessary data to progress a product through development. “CDMOs have specialized expertise gained through working with many different customers. This paired with the involvement of experienced regulatory experts from start to finish ensures the right statistical approach is adopted, as well as the right software, ultimately helping to shorten project timelines,” he says. “In addition, contract testing labs will not show any bias when it comes to approving the product. Testing will be done in a strict good manufacturing practice (GMP) environment.”
Furthermore, outsourced partners can offer guaranteed capacity to perform the correct tests within a timely fashion, Jagadeesan highlights. “The added global experience means that programmes will be planned effectively with the specific destination market in mind,” he states. “In addition, the requirements for staff at customer analytical labs is periodical. While the need for resources typically peak every three to six months, CDMOs can handle these peaks during any time due to performing multiple stability studies at once. This means that the workload can be handled evenly and efficiently.”
According to Jagadeesan, a reputable CDMO will have a demonstrable history of providing stability testing services for a wide array of products and will be aware of any potential pitfalls, and how to best avoid those pitfalls. “CDMOs offer both the infrastructure and breadth of experience to help clients arrange testing programmes that are relevant, cost-effective, and as streamlined as possible,” he says. “Taking the burden of testing away from pharmaceutical companies leaves in-house teams to focus on what they do best, namely R&D rather than routine testing.”
In agreement, Kottig notes that when employing a strong outsourcing partner, bio/pharma companies can focus on core competencies in product development. “From a CDMO perspective, during the past several years, it has become apparent that the service for stability studies is highly valued and appreciated by customers,” she adds. “In addition, there has been constant growth in this area.”
Additionally, Kottig reveals that sponsor companies have persistently increased requirements for stability studies. “Far more batches are undergoing stability testing, more storage conditions and relocations to other storage conditions are being required, and more freeze-thaw studies or cycling studies are being performed in comparison to a few years ago,” she says. “Oftentimes now, different test methods for particulate matter are being included within a single study to attain more information.”
“Ultimately,” Kottig summarizes, “there is a growing need for standardization in global marketing and the implementation of new approaches, allowing service providers increased flexibility and adaptability while providing the opportunity to streamline test execution, samples, and results.”
Pharmaceutical Technology Europe
Supplement: Partnering for Bio/Pharma Success
Pages: s14 and s21
When referring to this article, please cite it as F. Thomas, “The Benefits of Outsourcing Stability Testing,” Partnering for Bio/Pharma Success Supplement (March 2020).