In this review, MCB/WCB, which is an extremely important cell group for producing ATMPs, was briefly explained. Then, the regulations (GMP) that have evolved since the Kefauver-Harris Amendments have considered what kind of demands they have made on MCBs/WCBs, and the reasons for them.

We will share the results of a clinical trial we conducted overseas on a large volume wearable injector. Clinical trials were conducted with 52 subjects from a wide range of age, gender, and weight groups to evaluate the performance of the 5mL BD Libertas™ Wearable Injector (“Wearable Injector”, hereinafter, used as a generic name) in terms of tissue effects, skin reaction, and patient acceptability. Each subject received four injections (2 abdominal and 2 thigh) with and without movement for each location. We believe that these results demonstrate that a solution of 5 mL hyaluronic acid, which had been considered a large volume commonly, was able to be injected subcutaneously with Wearable Injector, without any major problems and without taking any additional measures for the solution and also that Wearable Injector did not significantly increase stress or have a significant negative impact on the patient's body during injections. Given the recent development of biologics that can be administered subcutaneously in larger volumes (>2 mL), we hope that the results of this study will contribute to the development and utilization of large volume subcutaneous injection by pharmaceutical companies, research institutions, and medical institutions.