03.03.23
ExoCoBio Inc. has obtained the "Certificate of Advanced Biopharmaceutical Manufacturing" from the Ministry of Food and Drug Safety in Korea and the "HA Filler GMP Certification" from the Brazilian Food and Drug Health Monitoring Agency (ANVISA).
This advanced biopharmaceutical manufacturing license was obtained in accordance with Article 23 of the "Act on Safety and Support for Advanced Regenerative Medicine and Advanced Biopharmaceuticals" and Article 9 Paragraph 3 of the "Rules on Safety and Support for Advanced Biopharmaceuticals." As a result, ExoCoBio earned the title of "Korea's first exosome-based advanced biopharmaceutical manufacturing company."
The Osong ExoGMP facility, which ExoCoBio has invested $20 million over the past three years, has 2 key features to be anticipated as a strategic asset in the global exosome industry:
1. The company says it is the world's largest exosome manufacturing facility for stem cells and others, and also aims to provide CDMO services worldwide from the site.
2. It has 220 equipment/instruments and 300 SOPs (Standard Operating Procedures) installed for advanced exosome-based drug manufacturing to produce purified exosomes for injectable regenerative medicine.
In addition, ExoCoBio recently achieved another GMP certification for hyaluronic acid (HA) fillers from ANVISA in Brazil. HA fillers are grade 4 medical devices. After this ANVISA GMP certification, ExoCoBio is expecting to export them to South America after product registration/approval in 2023, which will accelerate its growth of 50% per annum for next 3 years.
“Thanks to the hard work and effort of all employees and the support of investors, we have obtained the advanced biopharmaceutical manufacturing license in Korea and Brazil's ANVISA certification at the same time,” said Byong Cho, CEO and CTO of ExoCoBio. “We are the first South Korean biotech company to have three types of GMP manufacturing licenses simultaneously. Seeing this, I am pleased to have shown again our unmatched technologies and competitiveness in global exosome and medical aesthetic industry."
This advanced biopharmaceutical manufacturing license was obtained in accordance with Article 23 of the "Act on Safety and Support for Advanced Regenerative Medicine and Advanced Biopharmaceuticals" and Article 9 Paragraph 3 of the "Rules on Safety and Support for Advanced Biopharmaceuticals." As a result, ExoCoBio earned the title of "Korea's first exosome-based advanced biopharmaceutical manufacturing company."
The Osong ExoGMP facility, which ExoCoBio has invested $20 million over the past three years, has 2 key features to be anticipated as a strategic asset in the global exosome industry:
1. The company says it is the world's largest exosome manufacturing facility for stem cells and others, and also aims to provide CDMO services worldwide from the site.
2. It has 220 equipment/instruments and 300 SOPs (Standard Operating Procedures) installed for advanced exosome-based drug manufacturing to produce purified exosomes for injectable regenerative medicine.
In addition, ExoCoBio recently achieved another GMP certification for hyaluronic acid (HA) fillers from ANVISA in Brazil. HA fillers are grade 4 medical devices. After this ANVISA GMP certification, ExoCoBio is expecting to export them to South America after product registration/approval in 2023, which will accelerate its growth of 50% per annum for next 3 years.
“Thanks to the hard work and effort of all employees and the support of investors, we have obtained the advanced biopharmaceutical manufacturing license in Korea and Brazil's ANVISA certification at the same time,” said Byong Cho, CEO and CTO of ExoCoBio. “We are the first South Korean biotech company to have three types of GMP manufacturing licenses simultaneously. Seeing this, I am pleased to have shown again our unmatched technologies and competitiveness in global exosome and medical aesthetic industry."
