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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

 

Strain development services include:

 

  • E. coli and yeast host systems
  • Expression vector construction
  • Sequence 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 (including high-density 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 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 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

Analytical Development

 

The analytical method development team supports many CMC activities including:

 

  • Development of in-process, release and stability-indicating methods
  • Product biochemical, biophysical, and biological characterization, comparability and similarity assessment
  • Forensic and analytical investigation/trouble shooting for 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