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Microbial Services Development

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 high-standard global quality systems, which have continually completed multiple rigorous rounds of regulatory agency inspections. We provide expert, highly-efficient development services for biologics and 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


  • Innovative engineered E. coli and Yeast host systems
  • Optimized expression vector construction
  • Sequence optimization and signal peptide screening
  • Rapid strain development process
  • In-house cGMP cell banking and characterization
  • ZERO Royalty from research to commercialization


Drug Substance (DS) Process Development


Led by a team of experts, we offer batch and fed-batch (including High cell density fed-batch), fermentation process development 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 biotherapeutics and vaccines, supporting IND-enabling toxicology studies, or preclinical and CMC development activities at various scales.



Our capabilities include:


  • Clone selection support
  • Fermentation process development
  • Purification process development
  • Process verification for direct technology transfer
  • Non-GMP pilot production
  • Scale-up , technology transfer and clinical manufacturing support
  • Process characterization, optimization and validation
  • IND/IMPD & BLA filing support

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 and similarity assessment
  • Forensic and analytical investigation; troubleshooting of GMP manufacturing-related issues
  • Lot release and stability studies of non-GMP batches
  • Reference standard generation and characterization
  • Techology transfer to quality control (QC)


Formulation and Drug Product Development


We provide a dedicated team of highly-trained and experienced scientists capable of developing and optimizing biologics and vaccines product formulations filled into a wide variety of container and closure systems (CCS) including combination products (e.g., prefilled syringes and autoinjectors). The drug product development team also manages process scale-up and performance qualification activities and technology transfer to GMP operations.


Our capabilities include:


  • 500 m2 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)
  • Formulation of complex drug delivery systems including adjuvanted multivalent antigens, VLPs, lipid nanoparticles, emulsions.
  • Clinical in-use compatibility
  • Adjuvant selection and evaluation
  • Process scale-up, technology transfer and process performance qualification