“We’re a large company with different manufacturing sites and multiple filling lines in each site,” said Marc Steffens, Global Project Manager at Roche. “So it’s always been a challenge to establish harmonized processes, approaches, and strategies across our network. The same has been true for PUPSIT. The internal PUPSIT landscape is very diverse, and we have some sites and filling lines that do PUPSIT, while others don’t. As a result, we didn’t have a fully consistent strategy for how to assess the need for PUPSIT based on scientific considerations.”
Steffens added that the standardization of processes and the harmonization across the networks have always been key topics for Roche, so the BioPhorum/PDA consortium work is highly valued. “Based on this work, we have been able to establish guidelines to ensure that each site and each filling line is assessing this topic in the same manner. This will also improve our position when discussing our strategy with regulators or inspectors. For example, where we received previous observations, while not explicitly related to PUPSIT, inspectors noticed that one site does it one way while another does it differently. This leads to another critical step for us, towards a consistent approach.”
Steffens said that BioPhorum’s paper added value because Roche was looking for a more consistent strategy for PUPSIT as each site had previously created individual assessments.
These were not necessarily done in the same way and with the same focus. Most of the assessments focused on the risk of using a flawed, non-integral filter, but disregarded the product properties that could lead to clogging of a flawed membrane. But it’s the combination of these two issues that results in a flaw-masking risk, i.e., the only scientific trigger for PUPSIT.Marc Steffens, Global Project Manager at Roche