Lionel Jeannin, fellow, global packaging & device development, Novartis Pharma AG
The collaboration between biologics manufacturers and medical device supplier partners will be examined during an afternoon session at Pharmapack, “Challenges in packaging & devices development: biologics, materials, sustainability and quality consistency.”
Lionel Jeannin, fellow, global packaging & device development, Novartis Pharma AG, will be co-chairing the session along with Dr. Joel Richard, senior vice president, peptides, CMC & engineering, IPSEN. MD+DI asked Jeannin a few questions about such industry collaboration and the upcoming session.
MD+DI: The session description describes “collaboration with external partners like CMOs, suppliers and service providers.” Are there any challenges in such collaboration, and how can they be overcome?
Jeannin: The session will start with a presentation from colleagues of mine regarding key factors for successful collaboration with external partners when developing new packaging system for biologics. The challenges in that field are numerous and include the need for suppliers to have a thorough understanding of biologics and their specific sensitivity to potential contaminants such as substances that can leach from the packaging materials or can be derived from any additives used in their processing.
As a consequence, there is a need for a tight control and assessment of any changes made to the raw materials composition and processing, as well as to secure the long-term supply of specific raw material grades once they are approved and qualified. Also, when packaging components from different sources are associated in a same system, the performance of the system depends on the mutual fit of all components and can be disturbed by too significant variations in certain components’ critical dimensions or attributes that could be due to their manufacturing process. This is managed by the technical assessment of the whole system and the proper control of the manufacturing process at the supplier level. The complexity of such a technical assessment increases with the number of components and companies involved.
MD+DI: Can you describe briefly how Novartis’s organizational structure of the device development department has evolved?
Jeannin: Medical devices development at Novartis is relatively widespread. It is split across four main entities: a group focused on the development of devices and Software as a Medical Devices (SaMD) for pharmaceutical products; a group working in close interaction with biologics manufacturing and focused on device development for biologics; a group focused on device development for generics; and a group developing surgical devices and implants for the Alcon division.
MD+DI: Can you share one brief lesson learned about components sourced from suppliers?
Jeannin: Beyond the intrinsic performance and functionality of a defined packaging component, the level of mastery and control, by the supplier, of the manufacturing process and the raw materials used are crucial to the pharmaceutical industry and can make the difference when assessing components of higher but more unstable performance.
The session Jeannin described, “Key factors for successful collaboration on pharmaceutical packaging development for biologics,” will be presented by Alphons Fakler, group head risk management & Dr. Robert Hormes, group head packaging technology, Novartis AG. According to the session description, “Biologics are difficult to make and require special skills and expertise along the whole life cycle of the product in research, technical development and commercialization, manufacturing and product maintenance as well as specific infrastructure to produce on a significant scale. This not only affects the internal activities of pharmaceutical companies but also the collaboration with external partners like CMOs, suppliers, and service providers. Only if all involved parties work seamlessly together we will be able to deliver the right medicine to the right patient at the right time.”
Pharmapack will take place in Paris February 7-8, 2018.