Irene Cecchini, Researcher, Physico-Chemical Characterization Lab of Merck Serono caught up with Smithers Rapra in the lead up to her presentation at Extractables and Leachables Europe 2015. Find out what she had to say below:
Q:You are responsible for the management of E&L studies in final products container closure systems (CCS), final bulk storage containers, as well as for biotech products manufacturing processes, which product/process would you say poses the most challenges for E&L studies and why?
Certainly the most challenging studies are those on manufacturing processes (including SU parts) for several reasons: first of all there are many more variables to consider with respect to the studies on CCS (i.e. the choice of the worst case solutions in different process steps might be tricky, as well as the representative volume and contact time/temperature ….). Then we need to consider the difficulties in practically designing the study (i.e. the process contact material are normally big parts difficult to handle and not always it is possible to disconnect them from the system, especially in a DSP sizing hundreds of liters…). Furthermore, the risk of contaminations due to the design of a large scale system should be minimized as this might translate in analytical artefacts or results difficult to explain. There is a strong need of creating the right mind-set of the people involved in the manufacturing field (in terms of familiarity with E&L topic) because this might also have a strong impact in the results.
At last, the most important and difficult step in our view is the final use of the data generated for conducting a risk assessment taking into account the real use of the system and the final product presentation to determine the safety for the patients. In the next future we believe this will be the most important challenge to address for the E&L topic in the Pharmaceutical Industry.
Q: Your presentation will focus on certain case studies that you have come across in your role, are you finding that you are undertaking more extraction studies in your current work, than five years ago?
Yes, recently the HA attention to this topic is increasing and the consequently the requests for carrying out these studies, especially on the new products that are being launched in the market. New regulatory guidelines and Industry recommendations have also been issued.
Q: There are different study approaches for the DS/DP storage containers, could you outline these and which you prefer to follow at Merck?
The study design that we use is quite similar for DS and DP storage containers. If I have to say DS can be more tricky to address due to the larger volume of the batch size and to the different types of container (different plastic types and bags normally used).
Q: When you receive information from your suppliers, do you find that you are receiving sufficient information on the materials? If not, what changes would you propose to ensure that you have enough information for the manufacturing process?
Not really. We understand that suppliers apply standardized but not harmonized protocols and comply with regulations for the packaging materials but most of the times they perform very basic tests (like TOC and NVR or biocompatibility tests only) that are of limited use for us. However, sometimes, they are available to conduct customized studies for us. We are trying to influence suppliers’ community to adopt harmonized and standardized protocols through participation to International Pharmaceutical Industries Forums.
Q: What are you looking forward to about joining the speaker line-up at E&L Europe this year?
I am looking forward to listen to other Company’s views and to share not only approaches but also considerations on data interpretation and on the use of these data to meet the Regulatory’s and patient’s needs