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
Process Development
Analytical Development
Formulation Development

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 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