CMO SERVICE

GMP embodies various conditions for manufacturing high-quality medicine and is a norm that should be observed throughout the quality management process, from the arrival of raw materials to the shipment of the final product.We aim to manufacture high-quality pharmaceuticals with high stability by eliminating human errors that may occur in the pharmaceutical manufacturing process, along with minimizing contamination through automated manufacturing facilities and strict process control.

MicrobiotiX adheres to a strict quality control policies that meet global GMP regulations. We focus on delivering the highest quality products and services to our customers. This starts with ensuring high quality processes and facility operations are maintained. Our company policies are to have personal responsibility to maintain regulatory standards, promote a culture of quality compliance, and maintain world-class quality. Our leadership supports, recognizes, and rewards quality excellence. MicrobiotiX conducts risk assessments that can affect our product’s quality, stability, and/or efficacy by applying the ICH Q9 Quality Risk Management and ICH Q10 Pharmaceutical Quality System to the scientific information and data accumulated during development.

Throughout the production process, the quality control team conducts quality tests on all samples, including raw materials, in-process, DS/DP, and stability tests. In addition, the customer has the ability to transfer testing methods and perform testing method verification in accordance with the FDA, EMA, and PMDA requirements along with the ICH Q2(R1) guidelines. MicrobiotiX maintains an optimal working environment for producing high-quality products by routinely testing facility-related samples such as environment monitoring, water and steam quality, and clean gas systems. All tests are conducted in accordance with strict cGMP requirements. In addition various tests are routinely conducted to maintain an optimal working environment for producing products. For example, environmental monitoring, testing of the purified water for injection are conducted to sustain the optimal working environment

MicrobiotiX complies with global regulations for the highest quality. We were also founded on the principle of delivering better CDMO services with speed and a competitive price. In line with this principle, microbiotix is trying to redefine the concept of what good customer satisfaction can be and provide the highest level of customer satisfaction, the likes of which the pharmaceutical industry has never seen before. We will provide reliable, high-quality services at all levels, from sterile filing and foreign contaminant inspection to packaging.

GMP embodies various conditions for manufacturing high-quality medicine and is a norm that should be observed throughout the quality management process, from the arrival of raw materials to the shipment of the final product.We aim to manufacture high-quality pharmaceuticals with high stability by eliminating human errors that may occur in the pharmaceutical manufacturing process, along with minimizing contamination through automated manufacturing facilities and strict process control.

Incubation Room
Refinery
Charging Room
Quality Control Laboratory

GMP

Incubation Room

30L (Fermenter) incubator
automatic sterilization system
(SIP) applied

GMP

Refinery

TFF membrane (phage concentration)
IEX Chromatography (removal of Endotoxin)

GMP

Charging Room

Grade A(within the automatic vial filling machine) Production Management
10R, 10ml vial automatic filling
Production CAPA: around 200,000 vials/monthly

GMP

Quality Control Laboratory

Microplate reader (Endotoxin)
Microplate reader (ELISA)
Real time PCR
Microbiology Lab (BSC)

MicrobiotiX adheres to a strict quality control policies that meet global GMP regulations. We focus on delivering the highest quality products and services to our customers. This starts with ensuring high quality processes and facility operations are maintained. Our company policies are to have personal responsibility to maintain regulatory standards, promote a culture of quality compliance, and maintain world-class quality. Our leadership supports, recognizes, and rewards quality excellence. MicrobiotiX conducts risk assessments that can affect our product’s quality, stability, and/or efficacy by applying the ICH Q9 Quality Risk Management and ICH Q10 Pharmaceutical Quality System to the scientific information and data accumulated during development.

Quality Management Testing Capabilities

Throughout the production process, the quality control team conducts quality tests on all samples, including raw materials, in-process, DS/DP, and stability tests. In addition, the customer has the ability to transfer testing methods and perform testing method verification in accordance with the FDA, EMA, and PMDA requirements along with the ICH Q2(R1) guidelines. MicrobiotiX maintains an optimal working environment for producing high-quality products by routinely testing facility-related samples such as environment monitoring, water and steam quality, and clean gas systems. All tests are conducted in accordance with strict cGMP requirements. In addition various tests are routinely conducted to maintain an optimal working environment for producing products. For example, environmental monitoring, testing of the purified water for injection are conducted to sustain the optimal working environment

MicrobiotiX complies with global regulations for the highest quality. We were also founded on the principle of delivering better CDMO services with speed and a competitive price. In line with this principle, microbiotix is trying to redefine the concept of what good customer satisfaction can be and provide the highest level of customer satisfaction, the likes of which the pharmaceutical industry has never seen before. We will provide reliable, high-quality services at all levels, from sterile filing and foreign contaminant inspection to packaging.

01	We provide specialized service that includes: product development, process optimization for bacteriophage drugs developed by consigned companies, technology transfer, aseptic vial filling for the production of drugs for clinical trial and for the drugs which has gone through the clinical trials.
02	Our production capabilities and quality assurance system fully comply with Good Manufacturing Practice (cGMP) and global regulations to provide highest quality of the product.
03	MicrobiotiX is developing a treatment for intractable multidrug-resistant bacteria through bacteriophage R&D for more than 15 years. We provide consignment research and production services based on cGMP manufacturing facilities dedicated to bacteriophage and long-term R&D know-how.

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