Services & Capabilities

Microbial-Derived Product Services

Microbial Product Class

Services for microbial products

The microbial product class that stems from our microbial production system provides a single-source service for strain development through CMC dossier and regulatory support. Well-trained staff complement a global quality system that regularly passes rigorous regulatory inspections to deliver a product that meets the most stringent of requirements.

Key Features

From a DNA sequence to IND filing, our microbial program timelines are exceptionally fast. The single-source aspect facilities program transitions and mitigates the disruption of technical transfer.

First 4 months：
- Top 2 clones are selected
- Preliminary CMC process is evaluated
- Purified materials are available
- Check point for CMC readiness
4-month product-generating tool enzymes in a non-GMP laboratory
8-month technical transfer from master cell bank (MCB) and working cell bank (WCB) to IND
11-month iCMC process from pre-master cell bank (PCB) to IND

From antibody fragments to virus-like particles (VLPs), our microbial fermentation supports a variety of biologics products.

Virus Like Particles (VLPs)

Cytokines

Enzymes

Antibody Fragments

Plasmid DNA

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Microbial Development

Expert and efficient, our microbial development supports nucleic acid-based and protein-based biologics and vaccines produced through microbial fermentation. Explore the following highlights of this integrated service that builds a foundation for successful cGMP manufacturing.

Strain Development

Engineered E. coli and yeast host systems
Optimized expression vector construction
Sequence optimization and signal peptide screening
Rapid strain development
In-house cGMP cell banking and characterization
Royalty-free research to commercialization
EMA, MHLW & NMPA certified facilities
Meet global regulations (EMA, Chinese pharmacopoeia, ICH)

Process Development

Non-GMP plant specializing in process development, process characterization, technology transfer, and process scale-up
Innovative process development laboratories for microbial fermentation and purification
Well-defined dual-affinity tag system to facilitate enzyme expression and purification
Established technology and process for quick plug-in and optimization
High-throughput screening technologies with design of experiments (DoE) integration to accelerate process development for challenging molecules
Fermentation toolbox that enables titer and quality improvements
Successful 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 continuing where development ends, our cGMP manufacturing covers DS and DP to ensure you meet your preclinical and commercial supply needs with maximum cost-efficiency. Explore the following highlights of this integrated service offering.

Microbial Fermentation and DS GMP Manufacturing

One large-scale facility meets U.S., European, and Chinese cGMP requirements. For efficiency, the site employs the same comprehensive quality system as all our GMP facilities.

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

DS Highlights

80–110 DS batches per year
10,000 L stainless steel fermenter
FDA, EMA, NMPA, and cGMP requirements
Global quality system shared within WuXi Biologics
cGMP release for use by 1H 2026

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

A dedicated suite contains robotic aseptic filling systems for liquid DP manufacturing. The ability to fill microbial-fermentation DS, including lyophilized dosage, is also available.

Highly automated and highly flexible with advanced aseptic assurance
Grade A isolator under a Grade C environment background
Up to 20,000 units per batch to satisfy clinical manufacturing needs for various dosages
Equipped for special processing requirements
- An aseptic formulation isolator supports alum-adjuvanted vaccines
- A T-junction mixer with an ultrafiltration/diafiltration (UF/DF) unit supports LNP formulation
Ability to fill multiple ready-to-use (RTU) CCS
- Vials in 2R, 4R, 6R, 8R, 10R, and 20R formats
- Standard and long PFS at 1–3 mL
- Cartridges

Quality Control

A dedicated team of well-trained and experienced professionals improves product quality and safety and ensures regulatory compliance.

Qualified, cGMP-compliant analytical instrument
Analytical method transfer, qualification, and validation
Over 6,560 square feet of laboratories with dedicate space for microbiology, physical and biochemical tests, and potency assays
Environmental monitoring of facilities and utilities
cGMP testing services for cell banks, production materials, intermediates, and products
Data integrity promoted through a culture of training and assured with technical and procedural controls

WuXi Biologics has an ingrained commitment to quality. Our global quality system, QC, and operational systems 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. This approach maximizes efficiency and quality for confidence in the clinical and commercial production of DS and DP, both biologic and vaccine.

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