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Technology

Cell technology, manufacturing and quality control

A summary of the technologies EHL BIO publishes publicly, why each matters for patient safety, and which documents to ask for.

GMP Center

GMP centre information as published by EHL BIO, with educational notes on the key equipment.

GMP (Good Manufacturing Practice) is the quality-control standard regulators require for manufacturing food, pharmaceuticals, cosmetics and medical devices. It sets the minimum requirements for keeping quality consistent in production.

EHL BIO states it has GMP-suitable facilities with a culture capacity of 6,000 lots per year (500 lots per month), managed under the GMP framework of Korea's Ministry of Food and Drug Safety (MFDS).

October 2015

Completion of the 1st GMP centre

May 2016

GMP survey by the Ministry of Food and Drug Safety

April 2019

Completion of the 2nd GMP centre

Capabilities stated by the hospital

  • States it holds original technology for isolating and culturing adipose-derived stem cells.
  • States more than 100 cooperating hospitals in Korea.
  • States stem cell treatment available at more than 50 overseas partner hospitals.
  • Culture capacity of 6,000 lots per year (500 lots per month).

Stated permissions and approvals

  • Clinical approval for stem cell treatment in atopic dermatitis (the source page states Phase 2 in progress at time of publication).
  • CPC (Cell Processing Center) permission from the Japanese Ministry of Health, Labour and Welfare.
  • First human cell management business licence in Korea.
  • First CPC permission in Korea.

Key equipment in the GMP centre

01

Clean Room

  • Airborne particulates managed below the specified cleanliness level.
  • Cleanliness maintained to protect raw materials used in the manufacturing space.
  • Designed to control temperature and humidity, with incubators planned in from the design stage.

02

Biological Safety Cabinet (BSC)

  • Used in laboratories handling infectious materials such as pathogens.
  • Basic safety equipment protecting the handled material, the operator and the environment.
  • Classified as class 1, 2 or 3 according to the type and speed of inflow and exhaust air.

03

CO2 incubator

  • Tissue-culture thermostat maintaining a carbon-dioxide-supplemented gas environment.
  • Used to adjust the pH of the culture medium.
  • Supplies the set CO2 level and maintains temperature.

04

Centrifuge

  • Divides a homogenate into fractions using centrifugal force.
  • Spins at high speed and separates materials by particle size and density.

05

Inverted Microscope

  • Captures the image with an objective lens and refracts it through a prism for viewing from the front eyepiece.
  • Allows the morphology and function of proliferating cultured cells to be observed.

06

Liquid nitrogen tank

  • Used for long-term preservation of cells at cryogenic temperature.
  • Liquefied nitrogen exists as a liquid at -196 °C under atmospheric pressure.

07

Air Handling Unit

  • Device supplying outside air into the clean room.
  • Comprises heating coil, cooling coil, humidifier, air filter and blower unit.

08

HEPA Filter

  • HEPA stands for High Efficiency Particulate Air (99.97%).
  • Air purification device developed to remove airborne particulates.
  • Used where an entirely clean air environment is required for safety.

Information sources

Disease topics listed in the hospital's CURE section

This table lists the topics EHL BIO publishes, with verifiable status only. We do not state a development stage the hospital has not published.

EHL BIO disease topics and information status
TopicTargetCell typeInformation status
Alzheimer's diseaseCentral nervous systemMesenchymal stem cellsEHL BIO lists Alzheimer's disease as a topic in the CURE section, but no publicly verifiable development stage is stated.EHL BIO — CURE: Alzheimer
Degenerative arthritisJoints and cartilageMesenchymal stem cellsListed as a CURE topic with no verifiable development-stage information.EHL BIO — CURE: Degenerative arthritis
DiabetesMetabolic systemMesenchymal stem cellsListed as a CURE topic with no verifiable development-stage information.EHL BIO — CURE: Diabetes
Erectile dysfunctionLocal vascular and nerve tissueMesenchymal stem cellsListed as a CURE topic with no verifiable development-stage information.EHL BIO — CURE: Erectile dysfunction
CirrhosisLiverMesenchymal stem cellsListed as a CURE topic with no verifiable development-stage information.EHL BIO — CURE: Cirrhosis
Myocardial infarctionMyocardiumMesenchymal stem cellsListed as a CURE topic with no verifiable development-stage information.EHL BIO — CURE: Myocardial infarction
COPDLungs and airwaysMesenchymal stem cellsListed as a CURE topic with no verifiable development-stage information.EHL BIO — CURE: COPD
Autoimmune diseaseImmune systemMesenchymal stem cellsListed as a CURE topic with no verifiable development-stage information.EHL BIO — CURE: Autoimmune disease
Atopic dermatitisSkinMesenchymal stem cells, conditioned mediaListed as a CURE topic with no verifiable development-stage information.EHL BIO — CURE: Atopic Dermatitis

Not sure whether this applies to your case?

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