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

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