(ExoCoBio, 2.Mar.2023) — ExoCoBio Inc. announced that it 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 dollars over the past three years, has 2 key features to be anticipated as a strategic asset in the global exosome industry.
1) It is the world’s largest exosome manufacturing facility for stem cells and others, also aiming to provide CDMO services worldwide.
2) It has 220 equipment/instruments and 300 SOPs (Standard Operating Procedures) installed for the most advanced exosome-based drug manufacturing to produce purified exosomes for injectable regenerative medicine.
Moreover, 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.
Byong Cho, CEO & CTO of ExoCoBio, said, “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. We become 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 & medical aesthetic industry.”
About ExoCoBio, Inc. (www.exocobio.com)
ExoCoBio, as the world’s top 3 exosome biotech company, has the original technology for exosomes, and is a global leader who specializes in next generation exosome-based biologics and cosmeceuticals. It is leading the field of exosome-based medical aesthetics that help improve damaged skin worldwide, including the US, Europe, and Japan, and is also focusing on developing new drugs for serious diseases such as atopic dermatitis, acute respiratory distress syndrome, and inflammatory bowel disease.
What is Exosome?
As a major signal transmitter between cells in our body, it refers to the endoplasmic reticulum-derived nano sized particles composed of various physiologically active substances of nano size (30~200nm) secreted for information exchange between cells. Secreted by one cell, it induces immune regulation or activation in other cells, and plays an important role in influencing the microenvironment around the cell. Especially, stem cell-derived exosomes have strong intrinsic regenerative and anti-inflammatory efficacy. Exosomes have high potential for use in various fields such as cosmetics, diagnostics, and therapeutics because they can make effects on specific cells or strengthen active ingredients.