Analytical Testing

 

Analytical Testing

Experienced analytical researchers have a wide range of analytical experience and related knowledge.

Fast, reliable and accurate method development enables efficient process development and production.

Quality Assurance

Clean quality control and assurance

Prestige Biologics conducts environmental monitoring on a weekly to monthly basis, and manages the cleanliness of production facilities and test facilities at the world's highest level through identification and disinfection tests, and has a record of zero pollution / accident.

Prestige Biologics has experience in the development and production of new antibodies as well as biosimilars.

With the goal of providing high quality clinical and commercial product supplies to our customers and patients, we continuously improve our research and development, manufacturing and quality systems and processes to maintain the highest level of regulatory compliance.

Featured Test Methods and Equipment

Sample Control Best Test Capabilities
Store each sample in an independent chamber Raw Materials > Manufacturing > DS / DP Release > Stability Test
  • Quality control of all items from raw material warehousing to stability of DS / DP
Thorough storage and management of samples
  • Raw materials
  • Retention samples
  • DS / DP samples
  • DS / DP retention samples
  • Stability DS / DP samples
  • Stability DS / DP Retention Samples
 Physical Chemistry Test
  • pH, Osmolarity, Protein content, Appearance
  • FT-IR
  • HPLC
  • GC, ICP
  • Peptide Mapping
  • Specific optical rotation, etc
Biochemistry Test
  • ELISA (enzyme-linked immunosorbent assay)
  • Real Time PCR
  • Automated Electrophoresis
  • Anti-proliferation assay, etc.
Microbial Test
  • Bioburden
  • Endotoxin
  • Microbial limit
  • Sterility, etc.
Environmental and water monitoring

Regulatory

Regulatory Support

Fast and safe original drug production through Full Single-Use System

As a common international format for drug approval related to drug quality, it is documented and verified that R&D and manufacturing processes related to the quality of drugs (DS, DP) are consistently controlled and managed during the drug development process.

CTD Triangle

The five modules of the Common Technical Document (CTD), an internationally harmonized format used to present information on the quality, safety, and efficacy of pharmaceutical products, are often illustrated using the CTD Triangle to describe the document structure. Module 1 contains region-specific information, while Modules 2, 3, 4, and 5 contain content that is common across all regions.

eCTD

Module 1 Administrative information and prescribing information
Module 2 Common technical document summaries
Module 3 Quality
Module 4 Non-clinical study reports
Module 5 Clinical study reports