linkedin

QUALITY CONTROL

Our Quality Control (QC) team works closely with the Manufacturing, Quality & Compliance, and Analytical Development / MSAT teams to satisfy our customers, meet regulatory requirements, and ensure successful cGMP manufacturing operations. We remain committed to providing support for the production of high-quality biopharmaceutical products through optimized operating systems and processes.

Analytical Testing Capabilities

Across the manufacturing process, our QC team performs testing on samples including raw materials, in-process, DS/DP release, and stability. Our QC team is capable of performing analytical test method transfers from client laboratories, method validation, qualification, and verification in accordance to ICH Q2 (R1) guidelines, FDA, EMA, and PMDA requirements.

Our QC scientists provide their expertise based on the extensive experience they have acquired in GMP laboratory environments, and the use of validated cutting-edge equipment. The following are examples of some of the analytical test methods that our QC team is capable of:

Chemical
Testing
  • 1. Impurity / Purity by HPLC
  • 2. Identification by FT-IR
  • 3. Water content
  • 4. Osmolality, Protein Content (A280), Appearance, pH
Chemical Testing Chemical Testing
Biochemical
Testing
  • 1. Polymerase Chain Reaction (PCR)
  • 2. Enzyme-Linked Immunosorbent Assay (ELISA)
  • 3. Electrophoresis (gel-based / capillary electrophoresis)
  • 4. Cell-Based Assays
Biochemical Testing Biochemical Testing
Microbiological
Testing
  • 1. Sterility
  • 2. Microbial Limit (Bioburden)
  • 3. Microbial Identification
  • 4. Endotoxin
Microbiological Testing Microbiological Testing
Stability Program Capabilities

We maintain controlled areas that have validated and monitored stability chambers suitable for the collection of GMP Drug Product/Drug Substance stability data. The physical and kinetic stability profiles are generated with real-time storage conditions and accelerated conditions (with temperature and/or light).

Environmental and Clean Utility Monitoring

Through our routine testing of facility-related samples (environmental monitoring, water systems, clean steam, clean gas, etc.), QC guarantees that our controlled environments are maintained for the manufacturing of high-quality products. All analyses are performed under strict cGMP requirements. Environmental Monitoring includes the testing for Viable / Non-viable air particles and surfaces. Clean Utilities Monitoring includes the testing of water, compress gases, and clean steam for Bioburden, Endotoxin, TOC, Conductivity, Nitrate, Appearance, and pH.

SITE MAP

close
Close

Your download is ready

Click Download.

Close

Subscribe to Our Newsletter

Subscribe to our newsletter to download.
*If you have already subscribed, enter your email.

뉴스레터 구독 서비스 유무 확인
Close

Subscribe to Our Newsletter

Please fill in your details, select one or more areas of interest, and click the subscribe button to receive our newsletter.

Subscribe to Our Newsletter
  • Privacy Policy to collect the email address that I have provided until I withdraw my consent. The collected information will only be used for the purpose of mailing service. If you do not wish to consent, you will not be able to receive the newsletter. Samsung Biologics respects the privacy of its subscribers.
close

SECURITY REPORT

Your valuable comments contribute to protecting Samsung Biologic’s core technology and management information, as well as reinforcing domestic competency and economic development.

  • This page is created for reporting core technology and management information leakage.
  • The reported contents as well as the identity of the reporter are strictly secured.
THE MANUAL FOR SECURITY NOTIFICATION

Copyright Samsung Biologics. All rights reserved