How do we transition from large-batch manufacture to small-batch, high-value packaging runs?

This is the question driving the discussion and scoping activities of the Fill Finish Secondary Packaging program that was agreed at the FF20 meeting in March 2019. After initially focusing its activities on aseptic filling and lyophilization, Phorum leaders decided to explore collaborative opportunities in secondary packaging.

“Secondary packaging is a new and exciting area for the Fill Finish Phorum and we have been delighted by the enthusiasm from member companies,” said Dawood Dassu, Fill Finish Phorum Leader.

As many of our members are aware, there are lots of advantages of moving to smaller batches, including shorter leads times that improve organizations’ responses to changes in demand. The need for smaller batches is driven by the shift to medicines that target more specialized therapeutic areas. However, while the variety of medicines increases, the volumes of individual medicines are lower, but they are more costly to manufacture and bring to market. If organizations can’t deliver these in small batches, then it will mean holding inventory worth hundreds of millions of dollars that may not be sold within the product’s shelf life, leading to significant losses.

Many areas may affect an organization’s ability to make this transition. The Phorum is meeting this challenge and a team of company representatives has started to explore this area. It has held six virtual meetings that have focused on benchmarking their company’s current practices and identifying common challenges and areas for possible future collaboration.

Team focus

Four potential topics have emerged so far: digital printing, line clearance, serialization and robotics. A team-only benchmark survey has asked organizations about their line clearance activities, including how they define this activity and understanding where it fails. Initial findings suggest that the definition of line clearance between the companies is similar, but they appear to consider risks differently. Also, there is no consistent categorization of failure as some use a risk-based approach while others have pre-determined categories.

A first face-to-face meeting, PAK01, will be held on 29–31 October 2019 in Atlanta, Georgia and will focus on defining specific team objectives and shaping the collaborative activities for 2020. It will include a visit to Takeda’s facility in Covington, which will allow participants to review and compare secondary packaging processes.

For more information on the secondary packaging work or the PAK01 face-to-face meeting, please contact Jannika Kremer at jannika@biophorum.com