WuXi Biologics
Offering End-to-End Solutions
Microbial Services Development
Beginning from strain development to CMC dossier and regulatory support, our comprehensive end-to-end microbial platform services harness our highly-trained staff and world-class quality systems, which have continually completed multiple rigorous rounds of regulatory agency inspections. We provide expert, highly-efficient development services for vaccines produced via microbial fermentation, regardless of whether your product is nucleic acid- or protein-based. See below for more details on our one-stop service offering.
Strain Development
Strain development services include:
- E. coli and yeast host systems
- Expression vector construction
- Sequence/codon optimization and signal peptide screening
- Clone screening
- cGMP cell banking and release testing
Drug Substance (DS) Process Development
Led by a team of experts, we offer batch and fed-batch, and downstream purification process development of molecules in different expression systems. This includes, but is not limited to, intracellular soluble products, inclusion bodies, and extracellular secreted products. Our multi-purpose/multi-product 2,000 m2 process development laboratories facilitate the development of nucleic acid- or protein-based vaccines, supporting IND-enabling toxicology studies, or preclinical and CMC development activities at various scales.
Our capabilities include:
- Strain/clone selection support
- Fermentation process development
- Purification process development
- Process verification for direct technical transfer
- Non-GMP and pilot production
- Scale-up, technical transfer and clinical manufacturing support
- Process characterization, optimization and validation
- IND/IMPD & BLA filing support
Formulation and Drug Product Development
We provide a dedicated team of highly-trained and experienced scientists capable of developing and optimizing vaccine product formulations filled into a wide variety of container and closure systems (CCS) including combination products (e.g., prefilled syringes and autoinjectors).
Our capabilities include:
- Labs with processing and physicochemical testing ability
- Pre-formulation and formulation development
- Liquid, frozen liquid and lyophilized dosage form development
- Forced degradation studies
- Container closure selection/evaluation including vials and prefilled syringes (PFS), PFS with needle safety devices (NSD) and autoinjectors (AI)
- Formulation of complex delivery systems including adjuvanted multivalent antigens, VLPs, lipid nanoparticles, and emulsions
- Clinical in-use compatibility
- Adjuvant selection and evaluation
- Process scale-up, technology transfer and process performance qualification
Analytical Development
The analytical method development team supports many CMC activities including:
- Development of in-process, release and stability-indicating methods
- Product characterization (biochemical, biophysical, biological); comparability assessment
- Forensic and analytical investigation; troubleshooting of GMP manufacturing-related investigations
- Lot release and stability studies of non-GMP batches
- Reference standard generation and characterization
- Technology transfer to quality control (QC)
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