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Services & Solutions

GMP mAb Intermediate and Conjugation Manufacturing

Production Service from mAb Intermediate to ADC Drug Substance

 

The WuXi XDC GMP facilities are located in the Xinwu District, Wuxi, Jiangsu, China. The site is dedicated to ADC / bioconjugate drug development and manufacturing and the location holds a Drug Manufacturing License issued by the China NMPA. All the GMP facilities meet U.S. FDA and EMA GMP regulations and EHS requirements. Implementing next-generation facility designs for multi-product facilities, the site maintains separate mAb intermediate (including high potency mAb) production, pre- and post-viral (removal) production areas, and conjugation DS production. Up to 2 x 2,000 L scale bioreactors and separate downstream purification suites are available for mAb intermediate production as is two independent ADC drug substance production lines at a scale from 50 L to 2,000 L.

GMP Conjugation Manufacturing

 

At WuXi XDC, the conjugation manufacturing process for ADC/bioconjugate drug substance starts with payload-linker dispensing and consists of the conjugation reaction, purification and ends with bulk filling. The functional areas include conjugation, compounding, filling, lyophilization, QC laboratory, warehouse, and engineering utilities. There are two dispensing cabinets for weighing and dissolving highly-potent compounds, which include a stainless steel negative pressure isolator and a single-use plastic isolator.

The functional areas include conjugation, compounding, filling, lyophilization, QC laboratory, warehouse, and engineering utilities. The annual DS conjugation batch capacity is over 100 batches and WuXi XDC is expanding large-scale manufacturing capacity and adding automatic packaging capabilities in the future to meet the commercial supply demands of current and future clients.

 

At WuXi XDC, the conjugation manufacturing process for ADC/bioconjugate drug substance starts with payload-linker dispensing and consists of the conjugation reaction, purification and bulk filling. There are two dispensing cabinets for weighing and dissolving highly-potent compounds, which include a stainless steel negative pressure isolator and a single-use plastic isolator.

 

See the table for manufacturing capacities across the entire ADC/bioconjugate supply chain.

 

Manufacturing capacities across the entire ADC/bioconjugate supply chain

 

mAb Payload-Linker ADC Drug Substance (DS) ADC Drug Product (DP)
Lab scale √ √ √ √
Non-GMP
pilot scale		 √ √ √ √
cGMP
manufacturing		 > 2 kg > 5 kg Up to 5 kg 2~50 ml vials (up to 18,000 vials/6 hour run [2R vial])

 

5 ㎡ and 20 ㎡ lyophilizer

 

(up to ~85,000 vials/batch/day [2R vial])


 

Key equipment

 

  • OEB5 isolator for payload-linker dispensing and dissolution
    Mixing tanks (10 L, 50 L, 100 L, 200 L, 500 L, and 1,000 L)
  • Single-use glass or plastic bioreactors, (5 L, 15 L, 30 L, 50 L, 100 L, 200 L and 500 L)
  • AKTA Ready, UF/DF system
  • Auxiliary equipment such as parts washer and autoclave

 

For more information on the site’s capabilities and capacities – click here

Beyond drug substance (DS) GMP manufacturing, the site provides customized one-stop services to support everything from development to clinical and commercial drug product supply. This single-source platform greatly increases the efficiency of ADC / bioconjugate development and production. Additional capabilities at the site include:

 

All of our manufacturing operations are overseen by our comprehensive global Quality System that has been audited by multiple regulatory agencies including the FDA, EMA, NMPA, PMDA, MFDS, HSA, ANIVSA, HPRA and Health Canada.

GMP mAb Intermediate Manufacturing
This site provides GMP manufacturing of antibodies or other recombinant proteins produced from mammalian cell culture at a scale from 50 to 2,000 L. Capabilities include, vial thaw, cell culture, harvest, protein affinity chromatography, virus inactivation and neutralization, depth filtration, cation exchange chromatography, anion exchange chromatography, virus filtration, ultrafiltration/diafiltration (UF/DF), bulk formulation and fill. All of our manufacturing operations are overseen by our comprehensive global Quality System that has been audited by multiple regulatory agencies including the FDA, EMA, NMPA, PMDA, MFDS, HSA, ANIVSA, HPRA and Health Canada.

 

Facility Capacity

  • The mAb intermediate production capacity is up to 40 batches/year
  • GMP fed-batch bioreactor cell culture scale: 50L, 2x 250L, 2x 500 L, and 2x 2,000 L
  • Dedicated harvest room with continuous centrifuge and depth filtration
  • Two separate downstream production suites (with pre- and post-viral rooms)
  • Bulk drug substance fill in Biological Safety Cabinet (BSC)
  • Separate buffer prep and cleaning suites for pre and post viral activities
  • Media and buffer preparation in disposable systems
  • 50-2,500 L mixing tank for buffer preparation / process materials

 

Equipment Type Capacity
Bioreactor SUB G3Lite 50 – 2000 L
Chromatography System AKTA Process Ready/XL 10mm, 1inch, XL
Chromatography Column Chromaflow 300mm, 400mm, 600mm, 800 mm
Mixing Tank Jacket 50L-2500L
Nano-filtration Holder Viresolve Pro+ Magnus 0.51 – 10.71 m2
DF Holder Millistak POD Holder 5.5 – 33 m2
UFDF System Millipore-CUF180M 5-20 m2

 

For more information

 

White paper: The Watershed Moment for ADCs has Arrived

 

Podcast: Antibody Drug Conjugate (ADC) Development And Manufacturing Challenges And Solutions

 

Webinar: Antibody Drug Conjugates (ADC) drug development and manufacturing trends, challenges and solutions

 

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