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GMP DS and DP Manufacturing

As the leading Contract Research, Development and Manufacturing Organization (CRDMO), our comprehensive end-to-end microbial platform solutions beginning from strain development to CMC dossier and regulatory support harness our highly-trained staff and state-of-the-art global quality systems, which have continually completed multiple rigorous rounds of regulatory agency inspections. We support cGMP manufacturing of both DS and DP to effectively meet your preclinical, clinical and commercial supply needs in a cost-efficient manner.

 



Our large-scale microbial-based manufacturing facility is designed and constructed based on U.S., EU and China cGMP requirements. The site utilizes the same comprehensive quality systems implemented by all of our global GMP facilities.  Site details include:

 

  • BSL-1 facility with 2,000 m2 GMP manufacturing space
  • Multiple stainless steel lines scaling up to 2,000 L
  • Multiple single-use bioreactors with scaling up to 300 L
  • Flexible downstream lines with single-use technologies
  • Temperature control processing capability
  • One DS fill line

Drug Product Manufacturing of Microbial-derived Products

 

WuXi Biologics provides a full scope of drug product (DP) manufacturing services for microbial fermentation-derived therapeutics and vaccines, which includes process development, tech transfer, facility fit, robustness evaluation of DP manufacturing process.

 

Highly flexible and automated DP GMP manufacturing

 

  • 2× Vanrx SA25 robotic aseptic filling lines for clinical DP manufacturing (see below for more information on this state-of-the-art isolator-based system)
  • Aseptic formulation for Alum adjuvanted vaccines
  • Flexible container-closure systems including vials (2R to 20R) and prefilled syringes (1 mL to 3 mL long and normal). All primary packaging materials are ready-to-use (RTU)
  • Single-use systems covering the entire equipment train with no shared product contact surfaces

 

WuXi Biologics Successfully Completes PFS Filling at its Robotic Aseptic Filling Facility

Fully-automated, robotic, gloveless, isolator-based Vanrx aseptic drug product fill system at WuXi Biologics

 

In addition to Hangzhou site, fill of biologics and vaccines drug substance produced via microbial fermentation can also be performed in our various manufacturing facilities globally, including lyophilized dosage forms.

Our dedicated team of highly-trained and experienced professionals allows us to offer:

 

  • Analytical method transfer and qualification
  • In-process control testing support
  • GMP DS/DP release and stability studies
  • Over 1,450 m2 of QC space comprising of bioassay, physicochemistry, compendial testing, biochemistry, and microbiology laboratories as well as reference standard and stability storage rooms.