Manufacturing with GMP

Manufacturing process with Ultrasonic spray drying technology

SmartDepot™ is a platform technology and very continuous manufacturing process compare with emulsion type process. Both peptide API and polymer are dissolved in same solvent to put in ultrasonic spray dryer and harvested microsphere is going through refining process to be packed in vials.

Brief manufacturing process is as below.

  • Preparation of API-Polymer solution
  • Spray-drying
  • Post-processing
  • Washing and Filtration
  • Freeze-Drying
  • Packaging

Peptron’s Osong Biopark

As the GMP regulations are getting stricter in worldwide, Peptron made a decision to build its own manufacturing facility to supply investigational medicinal products (IMP) for planned clinical trials.

In Apr 2018, Peptron established own manufacturing facility in Osong, Korea, which can produce over 48,000 vials of SR-Exenatide per month. Area size is 16,378 square meters and research facilities for formulation and process development are located in same building. All manufacturing equipment and process are designed and installed under GMP guideline. To get appropriate GMP certification, preparation of related GMP regulatory pathway and application process are on-going.

In addition, Osong biopark has the latest advanced, cutting-edge facilities and uses them to produce the company’s superior products and follows a Quality Improvement program to ensure high standards.

It has a fully equipped laboratory to carry out all the necessary QC activities. Our laboratory is able to perform all the critical tests to meet GMP guideline and can effectively control and guarantee the best quality of manufacturing products.

Also, our research team is also working in same facility so our skilled, dedicated team enables to assure quality which meets customer needs, as well as optimizing cost and quality control. Therefore, research team will develop new, enhanced products which meet customer demands and QC team is actively monitor manufacturing products to ensure consistent levels of product quality and expectation.