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Microbial-Derived Product Services

Expert services for Microbial and mRNA products

WuXi Biologics employs a cutting-edge microbial production system to deliver expert, high-quality services that take microbial-derived products from preclinical development to manufacturing. The production system branches into microbial and mRNA product classes, supporting products expressed through microbial fermentation and messenger RNA (mRNA) derived from plasmid DNA (pDNA). Product development follows a rigorous CMC program that tailors every stage and activity to meet your needs. The versatility of our microbial product system ensures both flexibility and cost-effectiveness.

Our state-of-the-art GMP facilities feature a dedicated microbial-based manufacturing unit for pDNA production, along with vessels for mRNA transcription. Additionally, we offer comprehensive mRNA-LNP drug development, downstream purification platforms, and aseptic filling systems for drug product (DP) manufacturing built to exacting standards with premium equipment. Extensive expertise and a leading quality system round out our microbial services.

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Complete CMC development

Products developed from our microbial production system benefit from a comprehensive CMC development process with GMP manufacturing.

Microbial Product Class

A versatile microbial fermentation process enables the production of an array of modalities, including pDNA, enzymes, cytokine, virus-like particles (VLPs), antibody fragments, and other recombinant proteins. Our cGMP manufacturing includes a dedicated drug substance (DS) facility with a fermenter that scales up to a capacity of 2,000 L. The drug product (DP) side features aseptic filling systems powered by cutting-edge robotics.

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mRNA Product Class

Our microbial CMC development and cGMP manufacturing capacity encompass mRNA therapeutics and vaccines. A microbial-based facility with a fermenter that scales up to a capacity of 300 L produces pDNA. Multiple vessels cover an array of reaction volumes while dedicated equipment supports mRNA transcription and purification. For DP manufacturing, our facilities use mRNA-LNP drug development and robotic aseptic filling systems.

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Comprehensive service offerings from concept to commercialization

To enable clients to efficiently meet filing milestones, our microbial-derived product services are fully end-to-end. Each of the following product stages includes a comprehensive list of activities.

  • Research Material Generation
  • R&D Scale Protein Generation
  • Strain Development
  • GMP Cell Banking and Characterization
  • Fermentation Process Development
  • Purification Process Development
  • Analytical Development
  • Formulation Development
  • Drug Product Development
  • Pilot Manufacturing
  • GMP Manufacturing (Drug Substance)
  • GMP Manufacturing / Fill (Drug Product)
  • QC Release and Stability Testing
  • IND Filing / Regulatory Support
  • Technical Transfer
  • Strain Development / Optimization
  • GMP Cell Banking and Characterization
  • Fermentation Process Optimization / Characterization
  • Purification Process Optimization / Characterization
  • Process Characterization and Validation
  • Analytical Development and Validation
  • Final Formulation Optimization and Lock
  • Drug Product Development and Process Lock
  • Performance Process Qualification (PPQ) Runs
  • GMP Manufacturing (Drug Substance)
  • GMP Manufacturing / Fill (Drug Product)
  • QC Release and Stability Testing
  • BLA Submission / Regulatory Support
  • Non-GMP Manufacturing
  • Drug Substance GMP Manufacturing
  • Drug Product GMP Manufacturing
  • Quality Control
  • Packaging / Labelling

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Let’s discuss your project needs.
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