IN PARTNERSHIP
one vendor with an integrated offering at the manufacturing scale-up stage, especially in reducing complexity when preparing for an expanded clinical programme. While most early drug product manufacturers can supply a drug product to a single site phase I study, what happens when the trials expand for fast- tracked studies? It is important that the drug packaging and distribution can also scale-up along with the manufacturing process. Having a single vendor from early to late development avoids the time, effort and costs involved in bringing in an additional supplier or changing a packaging strategy mid-study – if the number of patients grows.
Using a supplier with integrated formulation
development, clinical manufacturing, and packaging and supply chain capabilities will achieve significant time-savings by avoiding separate service and quality agreements or safety assessments. Shipping delays between suppliers will be removed and parallel processing capabilities can be leveraged. By streamlining retained samples using an integrated supplier, potentially scarce API and drug product can be saved, and compliance with regulatory requirements can be maintained. Additionally, the costs associated with a non- harmonised cleaning validation or verification approach can be reduced. In 2015, the European Medicines Agency (EMA) revised its ‘Guideline on Setting Health Based
Exposure Limits for Use in Risk Identification in the Manufacture of Different Medicinal Products in Shared Facilities’, implementing health- based cleaning limits. This approach requires multiproduct facilities to move away from non- specific techniques, such as total organic carbon (TOC) for cleaning verification and validation in favour of more sensitive chromatography methods, such as HPLC and UPLC, especially for highly potent compounds. The development of these specific methods involves longer lead times and increases upfront costs. Using an integrated vendor can allow for
a harmonised cleaning verification strategy, removing the costs and times involved by each partner in the supply chain developing methods. Furthermore, interpretation of safety data used in calculating limits will be consistent – something that is challenging for early development programmes due to the lack of toxicology data. Working with a single partner with unified strategies can greatly streamline the process.
QP collaboration Another element to consider early in the drug development and manufacturing process is the need to involve a qualified person (QP). It is essential that teams work together to avoid delays in development, regulatory submissions and clinical milestones. Ideally, a QP should be engaged after the clinical strategy and potential
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