ISO9001-2008 (GB/T19001-2008) quality management system certification

Since founded in 2007, our company regard "respect for the customer, service first, scientific and technological innovation, meet demand" as our quality policy. First of all, company dedicated to promoting the internal management of systematic organization; secondly, company gradually establish a quality management system in accordance with ISO 9000 standards. In 2010, the establish quality management system passed ISO9001-2008(GB/T19001-2008) certification of the quality management system for the first time. Certification scope: biological reagents (proteins, antibodies) R&D and production

In accordance with the requirements of ISO9001-2008 quality management system, company developed quality management system documents, such as quality manuals, procedures, quality plans / SOPs and quality records, Quality activities have been carried out in order. Employees follow laws, reducing blindness of quality management system can be divided into four levels, including safety, management, equipment, quality control and research and development production, up to 536 SOP.

Company established a tripartite review mechanism of periodic audit: the first parth (internal audit), the second party (customer review), a third party (external audit) to assess the suitability, adequacy, effextiveness and effciency of the company's quality management system.

Product quality control system

Cell activity detection system

  • Cell Line Experience
  • ・~80Different established cell banks
  • ・~50 Types of tumor cell lines
  • ・More cell banks are being constructed
  • Experiences with Normal Cells
  • ・HUVEC
  • ・Cell separation: PBMC, T-cells
  • ・Others: Balb/c 3T3, Vero, Wish and etc
  • Experiences with Activity Assay Development
  • ・Over 200 methods for over 600 different products
  • ・14 Major classes of cell-based assays

Main types

  • Cell proliferation
  • Adhesion
  • Cellular differentiation
  • Cytotoxicity/CDC/ADCC
  • Apoptosis
  • Cell secretion
  • Chemoxis
  • TopFlash reproter/luciferase
  • Cell-based membrance protein binding assays
  • Calcium flux
  • KIRA-ELISA
  • Main applications
  • Assessment of product's biological functionality
  • Screen functionality/ neutralization capabilities of other new products
  • Process, stability, and customer support

Other analytical methods

  • Size-exclusion chromatography
  • Ion-exchange chromatography
  • HPLC-based prptide mapping
  • Reversed-phase HPLC
  • Amino acid analysis
  • SDS-PAGE
  • Endotoxin, bioburden, sterility
  • Immunohistochemisty
  • Flow cytometry
  • Westernblot analysis
  • Quantitative ELISA (binding with target-Ag, Fcg, C1q, and FcRn receptors, etc)
  • Affinity assessment
  • Mass Spectrometry (LC-Q-ToF)
  • Kinetics and Affinity (ForteBio)
  • Dynamic Light Scattering
  • Near IR-Fluorescence Gel Analyzer(Odyssey)
  • Mutiplex Luminex

Crtical Reagents in Antibody Selection and Its Effecter Function Evaluation

  • Assessing ADCC Effects and Others:
  • ・FcgR1, FcgRIIa, FcgIIb, FcgIIIa, FcgIIIb
  • Evaluation of Pharmacokinetics:
  • ・FcRn
  • Assessing CDC Effect:
  • ・C1q
  • Anti-Fcg Receptor Antibodies
  • ・a-FcgRI, a-FcgRIIa, a-FcgIIb, a-FcgIIIa, a-FcgIIIb

Pseudovirus Based Assays

  • 3 types of pseudoviruses had been set up
  • ・10 strains of human papillomavirus (HPV)
  • ・5 strains of avian influenza (H5N1)
  • ・2 strains of influenza(H1N1)
  • ・1 strains of VSV
  • ・1 strain of HIV
  • Pseudoviral assay application
  • ・Sample screening for hemagglutination test, ELISA, Westernblot, FACS etc.
  • ・High throughput antibody neutralization screening
    (96 or 384 wells plate, 10plate/day capacity)
  • Neutralization assay application
  • ・Screening neutralizing monoclonal antibodies
  • ・Evaluate viral vaccine effect
  • ・Broadly neutralizing antibody (BnAb) research
  • Other potential coming types of pseudovlruses
  • ・RSV, Rabies virus, HCV, EV71 and etc

Stability/Formulation Program Overview

Formulation Development Testing Support

Specific Parameter Method Comment
Concentration UV/Vis, BCA High Throughput
Integrity/Purity SDS-Page, Westernblot High Throughput
Aggregation HPSEC High Throughput
Deamidation CEX Medium Throughput
Oxidation Peptide Mapping Medium Throughput
Bi-molecular Interaction Functional ELISA High Throughput
Bio-potency Cell-based biofunctionality High Throughput

Note: Other biophysical methods are available through sourcing and collaborating with other institutes.

Refrigeratory monitor

All critical systems are under constant monitoring
Temperature 4C Units -20C Units -40C Units -80C Units
% of Coverage 20% 30% 60% 100%
System temperature management system
Frige/Freezer Unit Data Collection Data Convertor Commputer Database Management Client Inferface
Temperature   Temperature
Sersor
  Analog signal to digital   Central computer collect data from multiple units   Database center for storage, tracking and delivering warnings   Lab personnel project management and client can inquire data, request reprot, and issue change controls
Example of Record

Summary of Current Pollcy and Procedure Document

  • Safety
  • Training
  • Engineering Operation (procedures)
  • Analytical Operation (methods)
  • Equipment Operation
  • 259SOP
GMP Lab and Quality Assurance System Are Being Developed
Quality IS #1 for Us and it Means:
  • Quality in data
  • Reliability in delivery
  • Excellence in science
  • Caliber in people
  • Strictness in compliance
  • Trust in relationship
As Your Partner: We build and deliver what you needs, and help to accelerate your drug discovery