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High Quality and cGMP Manufacturing

 

All CMC activities including Process Development and cGMP Manufacturing activities for microbial fermentation-derived products are centralized to a singular Free Trade Zone in Hangzhou.

 

  • Convenient Transportation

 

    • 15 km from Xiaoshan International Airport (Hangzhou), 160 km from Shanghai (2 hours drive by car or 1 hour by high speed train from Pudong International Airport)

 

  • Extensive Experience

 

    • Leadership team has over 10 years of industry experience Highly educated staff: 15% Ph.D., 66% M.S., 17% B.S. 
    • Region provides access to excellent scientific talent pool

     



High Capacity and Flexibility of DS Manufacturing

High Quality (HQ) and cGMP manufacturing are located in one building to provide high flexibility for material generation, process scalability and robustness evaluation. Facility will be operational by Q3 2021.


  • HQ Pilot Production

 

    • 110 m2 HQ suites
    • 10-50 L scale fermenters
    • Fully operational by Q4 2020 

     

  • High Capacity and Flexibility in GMP Manufacturing – MFG14

 

    • BSL-1 facility, cGMP ready by Q3 2021
    • 2,000 m2 GMP suites with single-use and stainless steel fermenters
    • Upstream: One single-use fermenter line with scale up to 300 L 
    • Upstream: three stainless steel lines with scale up to 2,000 L 
    • Downstream: three purification lines
    • One integrated production line with both upstream and downstream in one ball room
    • One Drug Substance fill line

Microbial Platform can utilize existing GMP DP formulation and fill sites for protein products.

 

DP Site
DP Capacity
GMP Ready
Location
Comments
DP1
Liquid vial with lyophilization

2013

(CN/EU/US Compliant)

Wuxi, China
Commercial
DP2
Liquid vial with lyophilization

Q2 2021

(CN/EU/US Compliant)

Wuxi, China
Commercial
DP3
ADC conjugation and DP

Q3 2019

(CN/EU/US Compliant)

Wuxi, China
Clinical
DP4
Vial/PFS

Q3 2019

(CN/EU/US Compliant)

Wuxi, China
Clinical
DP7
Liquid vial

Q4 2020

(US/EU Compliant)

Leverkusen, Germany
Commercial

 


Location
  • Shanghai – analytical and bioassay release and stability testing
  • Hangzhou – EM and in-process controls (IPC) testing
Services
  • Analytical method qualification and method transfer
  • GMP DS/DP release and stability testing for clinical products
Employees
  • Over 140 highly-trained and experienced QC staff
  • More than 60%  employees have an M.S. and greater degree 
Facilities
  • ~ 170 m2 for Bioassay lab (~ 1,800 sq ft )
  • ~ 200 m2 for Physicochemistry (~2,200 sq ft )
  • ~ 150 m2 for Biochemistry lab (~1,600 sq ft )
  • ~ 200 m2 for Compendial and Raw Material lab (~2,200 sq ft )
  • ~ 300 m2 for Sample, RS and Stability room (~3,200 sq ft)
  • ~ 200 m2 for Microbiology  lab (~2,200 sq ft in Hangzhou)
  • ~ 300 m2 for Physio/Biochem IPC testing (~3,200 sq ft in Hangzhou)