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威尼斯569vip游戏生物

Clinical Sample Production

Quality Control

Core Advantages

  • At present, the first phase of 1,478.0-square-meter comprehensive laboratories is in operation; and another 1,000-square-meter area will be expanded in the second phase, which is expected to be put into operation in the second half of 2022.
  • Adequate number of international top brand analytical instruments (including liquid phase, gas phase, capillary electrophoresis, qPCR, UV, IR, etc.).
  • Complicated technical platform (physicochemical platform, instrumentation platform, biochemical platform, microbiology platform).
  • Quality system platform to provide sound laboratory system services in line with domestic and international regulations.
  • Electronic data control is fully compliant with electronic records/electronic signature control process specified in part11, 21CFR.
  • High-quality professional analysis team led by a number of professionals from multinational and domestic well-known companies with rich laboratory experience.
  • The test methods research team members all have PhD degrees, with powerful methods development capabilities.

Service Content

...
Analytical development and quality control of innovative biologics

Product specifications formulate / Impurity studies / Other quality studies
Analytical methods development, validation, verification and transfer
Quickly resolve various analytical problems encountered by customers
Support the quality content writing of IND and NDA registration dossiers of products

...
Product stability study

Affecting factor test (light, shock, high temperature, freeze-thaw) (1 batch of bulks and 1 batch of formulation)
Accelerated stability test (2 batches of bulks and 2 batches of formulation)
Usage condition simulating test
Long-term stability (3-36 months) (2 batches of bulks and 2 batches of formulation, reference product and placebo)

...
Testing services for pharmaceutical raw and auxiliary packages

Provide raw materials and excipient testing in accordance with national pharmacopoeias
Provide package materials testing to meet national pharmacopoeia requirements including package materials compatibility related stability studies
Development of additional test items required by other customers

...
Plant environmental testing, water system monitoring

Support testing services environmental systems, water system verification of newly built plants
Support daily water system and environmental system monitoring services

Clinical Sample Production

Quality Control

Core Advantages

  • At present, the first phase of 1,478.0-square-meter comprehensive laboratories is in operation; and another 1,000-square-meter area will be expanded in the second phase, which is expected to be put into operation in the second half of 2022.
  • Adequate number of international top brand analytical instruments (including liquid phase, gas phase, capillary electrophoresis, qPCR, UV, IR, etc.).
  • Complicated technical platform (physicochemical platform, instrumentation platform, biochemical platform, microbiology platform).
  • Quality system platform to provide sound laboratory system services in line with domestic and international regulations.
  • Electronic data control is fully compliant with electronic records/electronic signature control process specified in part11, 21CFR.
  • High-quality professional analysis team led by a number of professionals from multinational and domestic well-known companies with rich laboratory experience.
  • The test methods research team members all have PhD degrees, with powerful methods development capabilities.

Service Content

...
Analytical development and quality control of innovative biologics
  • Product specifications formulate / Impurity studies / Other quality studies
  • Analytical methods development, validation, verification and transfer
  • Quickly resolve various analytical problems encountered by customers
  • Support the quality content writing of IND and NDA registration dossiers of products
...
Product stability study
  • Affecting factor test (light, shock, high temperature, freeze-thaw) (1 batch of bulks and 1 batch of formulation)
  • Accelerated stability test (2 batches of bulks and 2 batches of formulation)
  • Usage condition simulating test
  • Long-term stability (3-36 months) (2 batches of bulks and 2 batches of formulation, reference product and placebo)
...
Testing services for pharmaceutical raw and auxiliary packages
  • Provide raw materials and excipient testing in accordance with national pharmacopoeias
  • Provide package materials testing to meet national pharmacopoeia requirements including package materials compatibility related stability studies
  • Development of additional test items required by other customers
...
Plant environmental testing, water system monitoring
  • Support testing services environmental systems, water system verification of newly built plants
  • Support daily water system and environmental system monitoring services

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