ISOLATOR LAUNCH IN SOUTH KOREA

Aprogen is a young company founded only in the year 2000. Beyond its home market in South Korea, the innovative company is already active in Japan and the USA. Various biosimilars as well as self-developed biologically-based active pharmaceutical ingredients are in the process of being approved. The founder and owner is Dr. Jaeseob Kim, who was previously a professor at the Korea Advanced Institute of Science and Technology (KAIST) in Daejeon. He is regarded as one of the leading pharmaceutical experts in South Korea. Aprogen has received much professional recognition for a system developed in-house for the production of cell cultures that is both productive and cost effective.
 
Oh-sung Na is responsible for "Fill and Finish" at Aprogen Biologics Inc. How did the decision to go with isolator technology come about in the company? There are several answers to this question. "As you know, the required background environmental conditions of the clean room differ between Grade C and B, depending on whether an isolator or a RABS (Restricted Access Barrier Systems) is installed, respectively. This means that, in the future, we will benefit from the less demanding environmental requirement, which will give us a cost advantage. At the same time, VHP decontamination in the isolator leads to a higher level of safety and quality of the product. Isolator technology is also more attractive to regulatory agencies of various countries. As a result, my CEO has strongly supported and invested heavily to secure an isolator."

The system is designed for a dedicated syringe system and for filling quantities from 0.5 ml to 20 ml. One question was, how could the double-packed syringe tubing be processed automatically? For Aprogen, this question was to be one of the decisive factors for the investment decision. "The second bag sits very tightly, hence a constructive solution was important to me, because otherwise, cutting the bag could lead to more problems. Other vendors were unable to offer this. I wanted to avoid any complicated and unnecessary procedures." Two consecutive bag unpackers resolve this problem.  The second debagger uses vacuum technology to align the film for cutting, so that it can be removed easily and safely. The OPTIMA Tyvek Removal Robot then removes the Tyvek paper.

The technical concept provides for a ten-digit filling station with peristaltic pumps, after removing the nest from the tub. There is an automatic weight check. The Aprogen system will already be prepared for filling and sealing under vacuum as a retrofit option. Each tub will receive a data matrix code that will be controlled by an OCV (Optical Character Verification) sensor. The modular system will work starting from the unpacking unit up to and including the insertion of the stopper under isolator. Materials can be safely fed into the aseptic area via a MTC (Material Transfer Chamber) airlock that can be decontaminated. The output is in the high performance range, with up to 36,000 syringes per hour.

Another important point for the decision to invest in Optima – as well as the special solutions for unpacking the tubs – was also the references provided.
 
Peter Kim knows that the service capacities were also rated as an important aspect by Aprogen. At present, the project is still at an early stage. In regards to the experience so far, Oh-sung Na reports: "I developed a lot of trust during the course of the mock-up and the design review. I was also impressed by the technical knowledge and professionalism of Optima and Metall+Plastic".
 
During the development phase, ideas from both sides, from both Aprogen and Optima, were also discussed. The 45 year-old looks back on this time positively: "The ideas put forward by Aprogen were positively received and considered by Optima. Some of them were adopted, while others were not incorporated per Optima’s recommendations, all of which were clearly explained and comprehensively justified."