Services & Capabilities

Microbial-Derived Product Services

Microbial Product Class

Setting the Standard for Microbial Product Services

WuXi Biologics’ microbial production system provides an integrated, end-to-end service with regulatory support. Expert staff complement a thoroughly validated, centralized quality system to deliver high-quality product aligned to global regulatory requirements. Cutting-edge technologies Like EffiX E. coli expression system drive exceptional productivity scaled to transition smoothly from research to commercialization.

Build Your Next Breakthrough

Superior Speed across Modalities

Reach development milestones faster with WuXi Biologics. From DNA to IND, we offer streamlined processes and expert guidance to reduce your timeline while ensuring high-quality outputs. Our integrated service eliminated common delays such as technology transfer, providing predicable, accelerated results without sacrificing quality or compliance.

Months 1–4
- Select the top clones
- Evaluate the preliminary CMC process
- Access purified materials
- Confirm CMC readiness
Four months
Use tool enzymes to generate product in a non-GMP laboratory
Eight months
Conduct technology transfer from the master and working cell banks to IND
Eleven months
Perform iCMC processes from the pre-master cell bank to IND

Virus Like Particles (VLPs)

Cytokines

Enzymes

Antibody Fragments

Plasmid DNA

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Expert Microbial Development Tailored to Your Needs

Expert and efficient, our microbial development supports protein- and nucleic acid-based biologics and vaccines produced through advanced microbial fermentation. Partnering with WuXi Biologics grants access to scalable production and innovative technologies that minimize risk, accelerate timelines, and adapt to your needs.

EffiX^TM is our advanced microbial system for E. coli expression, available as EffiX^TM P for recombinant protein and EffiX^TM S for plasmid DNA. Leveraging cutting-edge technology, the system delivers industry-leading yields with exceptional purity.

Engineered for efficiency and scalability, EffiX^TM minimizes process variability while maximizing product productivity and quality. Through innovative strain engineering and optimized workflows, EffiX^TM seamlessly transitions from research to commercialization.

Other Highlights

System for engineered yeast
Optimized expression vector construction
Sequence optimization and signal peptide screening
In-house cGMP cell banking and characterization
Royalty-free research to commercialization
Facilities certified by EMA, MHLW, and NMPA
Meets global regulations: EMA, ICH, and Chinese pharmacopoeia

Process Development

Non-GMP plant specializing in process development, process characterization, technology transfer, and process scale-up
Process development labs dedicated to microbial fermentation and purification
Dual-affinity tag system that facilitates enzyme expression and purification
Established technology and process for plug-and-play operation
High-throughput screening integrated with a design of experiments (DoE) framework to accelerate process development for challenging molecules
A fermentation toolbox for improvements to titer and quality
Scale-up from 10 L to 50, 200, 500, and 2,000 L

Separate room and equipment are dedicated to E.coli and Yeast fermentation. Different types of bioreactors support fermentation development at scales ranging from 200 mL to 10 L.

A variety of equipment, depending on your needs, can be utilized for controlling low-temperature purification processes.

Analytical Development

Development of in-process, release, and stability-indicating methods
Product biochemical, biophysical, and biological characterization plus a comparability and similarity assessment
Forensic and analytic investigation and troubleshooting for issues related to GMP manufacturing
Reference standard generation and characterization
Technical transfer to quality control (QC)

Formulation Development

Over 1,640 square feet of laboratory space with processing and physicochemical testing abilities
Pre-formulation and formulation development
Liquid, frozen liquid, and lyophilized dosages
Forced degradation studies
Choice of a vial or prefilled syringe (PFS) container closure system (CCS) and evaluation
Clinical in-use compatibility
Adjuvant selection and evaluation

Microbial Manufacturing

Smoothly transitioning from development, our cGMP manufacturing delivers drug substance (DS) and drug product (DP) at scale. With a flexible framework and focus on cost efficiency, we meet all your preclinical and commercial supply needs.

With one cGMP facility, we ensure your DS meets all requirements for the U.S., EU, and China.

Over 9,840 square feet of cGMP manufacturing space
Three stainless steel lines that scale up to 2,000 L
Single-use bioreactors that scale up to 300 L
Flexible downstream lines with single-use technology
Temperature control processing
One DS fill line

Anticipating cGMP release by 2026, our Chengdu, China facility meets all FDA, EMA, and NMPA requirements.

About 18,000 square meters of manufacturing space
Annual production of 80–110 DS batches
One 10,000 L stainless steel fermenter
Anti-explosion design
Temperature-controlled processing compatible with unstable molecules
Multiple column sizes for high-titer and low-load capacity projects
One independent, automated DS fill line
In-line condition system

MFG27 in Chengdu, China

18,000 m² DS manufacturing facility
Anti-explosion design that accommodates diverse modalities
Temperature-controlled processing compatible with unstable molecules
Multiple column sizes available (column i.d. up to 2 meters) for high-titer and low-load capacity projects
One independent DS fill line equipped with an automatic filling machine
In-line condition system offering efficiency, continuity, flexibility, a small footprint, and reduced cost

Drug Product Manufacturing

Robotic aseptic filling systems equip a suite dedicated to liquid DP manufacturing. We can also fill microbial-fermentation DS, including lyophilized dosages.

Highly automated with advanced aseptic assurance
Grade A isolator in a Grade C environment
Up to 20,000 units per batch to support various dosages
Accommodates special processing requirements:
- An aseptic formulation isolator supports alum-adjuvanted vaccines.
- A T-junction mixer with an ultrafiltration/diafiltration unit supports liquid nanoparticle formulation
Able to fill multiple ready-to-use CCS:
- Vials in 2R, 4R, 6R, 8R, 10R, and 20R formats
- Standard and long PFS at 1–3 mL
- Cartridges

Quality Control

Our well-trained and experienced professionals improve product quality and safety to ensure regulatory compliance.

Labs covering over 6,560 square feet with dedicated space for microbiology, physical and biochemical tests, and potency assays
Qualified, cGMP-compliant analytical instrument
Analytical method transfer, qualification, and validation
Environmental monitoring of facilities and utilities
CGMP testing services for cell banks, production materials, intermediates, and products
Assured data integrity through a culture of training and technical and procedural controls

WuXi Biologics’ ingrained commitment to quality is apparent in our quality system, QC, and operational systems, which are well-established and meet or exceed standards set by the FDA, EMA, NMPA, and other major regulatory agencies worldwide.

We have harmonized our quality assurance (QA) and quality management system across all global sites—an approach that maximizes efficiency and quality for confidence in the clinical and commercial production of DS and DP.

Related Resources

[Webina] Novel Biologics Development and Manufacturing with WuXi Biologics’ Microbial Platform

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