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Tony Pidgeon, process technology director at Patheon discusses challenges associated with and recent innovations in the fill/finish process for biopharmaceuticals.
Filling and finishing sensitive biopharmaceutical products can be challenging-manufacturers must consider factors including delamination, extractables and leachables, particulates, and aggregation. BioPharm International sat down with Tony Pidgeon, process technology director at Patheon, to discuss trends in fill/finish processes for biopharmaceuticals.
BioPharm: What are some recent innovations to aseptic processing technologies used in fill/finish procedures?
Pidgeon: Primary packaging containers made of cyclic olefin polymers (COPs) are now a viable alternative for sensitive biopharmaceutical products, which can interact with containers made from glass. Issues such as delamination, particulates, and aggregation may be avoided when the primary container is made from COPs. COP containers are likely to also offer improved robustness as they are less prone to breakages.
BioPharm: Can you discuss any recent trends in the automation of fill/finish processes? Is automation preferred, why or why not?
Pidgeon: There has certainly been an increase in the automation of fill/finish processes. Automated recipes, for example, can certainly help reduce human error in set-up and running of routine fill/finish processes. However, this can then limit the flexibility required to run non-routine manufactures, as seen in a development facility.
BioPharm: What are the benefits of using single-use systems for fill/finish compared with stainless steel?
Pidgeon: There are many benefits to using single-use systems for fill/finish compared with stainless steel. From a quality and safety point of view, there is a dramatic reduction in the risk of cross-contamination and also a reduction in cleaning verification or validation. There are also many economic advantages; set-up and clean down times can be dramatically reduced, thereby increasing capacity, and reducing labor costs. There is also a reduction in capital costs and the use of water and utilities, and chemicals are reduced.
BioPharm: What are some challenges associated with using a single-use system for fill/finish? How might you address these challenges?
Pidgeon: Single-use systems can have some limitations. For example, peristaltic dosing pumps are often used on fill/finish lines and the dosing accuracy isn’t great for the more viscous products. Extractables and leachables are a concern for some drug product manufacturers when using single-use systems, due to the amount of plastic product contact parts. The suppliers of single-use systems can assist drug product manufacturers by helping risk assess the potential extractables and leachables for their particular products.