Category | Large Molecule
New is always exciting. The recent opening of Thermo Fisher’s Pharma Services development and manufacturing facility in Hangzhou, China, was no exception. As the first Thermo Fisher site to offer integrated biologics drug substance and steriles drug product capabilities under one roof, the facility itself and the possibilities it represents for biopharma customers in the Asia Pacific region and globally have generated significant interest and anticipation across the industry.
Of course, newness, by definition, is transient. In biopharma manufacturing, delivering on the promise of a new site, a new technology, or even a new process requires history, experience, and deep industry knowledge. Nowhere is this distinction more true than in the quality and regulatory arena.
“Our customers are excited to learn about the advanced technologies, resources, and capacity that will support and accelerate their end-to-end workflows, but they also want assurance that the quality systems being rolled out in a new site—whether it’s in Hangzhou or anywhere else—is the exact same quality system framework that is used across the Thermo Fisher network,” according to Luis Menendez de Luarca, Thermo Fisher Senior Director of Quality. The implementation of the quality system may have site-specific dependencies based on regulatory and other regional considerations, but it’s the consistency of the underlying quality framework that provides the reassurance they are looking for, he explained.
To provide guidance to biopharma companies seeking to take advantage of the Hangzhou site capabilities, Menendez de Luarca and colleague Qijun Zhang, Director of Quality for the Hangzhou site, sat down to answer some questions about the quality-related considerations that are foundational to a successful CDMO partnership. They also offered insight into the Thermo Fisher quality systems framework that guides the quality systems implementation at the Hangzhou site.
Q: What assurance measures are most important for GMP manufacturing at a new site?
A: Customers should feel confident that process and product quality are harmonized across all sites in a global network. To this end, Thermo Fisher has harmonized quality systems standards implemented across all sites, including quality management processes, standard operating procedure (SOPs), Good Manufacturing Practices (GMP) quality systems, adherence to GMP, and relevant regulatory standards. All facilities in the global network, including the new site in Hangzhou, adhere to the harmonized quality systems standards.
Q: Different regions of the world are bound by different regulatory requirements. How does this affect quality systems implementation?
A: Regulatory compliance is encompassed within the quality systems framework. Depending on where pharmaceutical sites are located throughout the world and where their products will be distributed and marketed, each site will need to comply with regulations that are enforceable by the regulatory agencies of the regions where the drug is manufactured, distributed, and marketed, as well as Thermo Fisher Pharma Services global quality standards. The new biologics site in Hangzhou, for example, is being fully integrated in Thermo Fisher quality systems, which are aligned with the relevant local and international regulatory requirements.
Q: What role does technology transfer knowledge and experience play in ensuring quality consistency?
A: Technology transfer is a critical process for ensuring that safety, quality, and efficacy are maintained through the product lifecycle, from development to commercialization.
Robust processes for transferring knowledge, procedures, and expertise from established sites to a new facility are essential to maintaining consistent quality across different sites and minimizing risks associated with technology transfer.
In addition to the processes themselves, all staff at the new facility must be properly trained on the processes, equipment, and quality standards. Finally, there is no substitute for the value of experience and expertise. For example, the collective experience of the leadership team for the Hangzhou site includes more than 45 successful technology transfer projects. Additionally, the Hangzhou site is integrated into Thermo Fisher’s biologic and drug product technical network, with broad experience in technology transfer across all of the sites.
Sites such that offer end-to-end development and manufacturing services for drug substances and drug products eliminate the need for technology transfers as well as the risks of multiple contracts, mechanisms, protocols, and points of contact that arise when working with more than one partner.
Q: Are there additional considerations that contribute to quality confidence?
A: There are a number of important organizational and cultural considerations related to quality oversight and quality experience and mindset.
In terms of oversight, quality across all sites should be evaluated by a site-independent quality assurance (QA) team that conducts regular inspections, audits, and quality control testing to ensure processes and products meet the required standards. Structuring quality auditing process oversight in this way ensures that new facilities are subject to the same quality checks and oversight as other sites within a global network.
Culturally, a commitment to continuous improvement and transparent communication are essential. Evidence of a continuous improvement mindset includes processes for monitoring and measuring site performance on key quality measures, as well as robust review and feedback mechanisms to help identify areas for improvement and support prompt and appropriate corrective actions when issues arise. Regarding transparency, customers should feel confident in their ability to communicate their quality expectations. And site leadership should provide clear information about the quality systems and processes at the global level that govern the site implementation.