Wednesday, October 30^th - 15:50 to 16:20 pm (GMT+9)

«Risk mitigation in Combination Product Development for Biosimilars: Case Study on Prefilled Syringe Functionality and Autoinjector Performance»

Enrico Barichello, Product Manager at Stevanato Group

Biopharmaceutical and Biosimilar Companies have an increasing interest in developing prefilled syringe and autoinjector combination products for their injectable molecules. In addition to the standard evaluation of drug stability, in the early stage of drug development the thorough assessment of the compatibility between drug product, container-closure system (CCS) and injection device is recommended. Based on an actual case study developed for a Biotech Client, this paper illustrates the testing methods and rationales specifically applied in the assessment of syringe and device functionality, exploring key performances of the injection system as a whole. Advanced syringe coating techniques to prevent unwarranted drug, CCS and device interactions over time, resulting for example in variability of the injection duration, are also disclosed.

Wednesday, October 30^th - 15:45 pm to 15:50 pm (GMT+9)

SESSION VII: Combination Products

Session Moderator:
Paolo Golfetto, Director of Business Development, Drug Delivery Systems at Stevanato Group