Microbial Expression and Fermentation Platform
Microbial Expression and Fermentation Platform
WuXi Biologics has become a leading global biologics Contract Development and Manufacturing Organization (CDMO) for our partners and clients because of our “truly ONE” concept to commercialization drug development platform and excellence in project execution. To continue to support the biologics industry and our client’s needs we have established extensive and state-of-the-art technologies for the development and cGMP manufacture of proteins and plasmid produced from microbial expressions systems.
Types of Biologics and Vaccines
We have the expertise to develop and produce a wide-variety of biologics and vaccines from our various microbial platforms.
Microbial Expression Systems
Recombinant proteins, plasmid and other biologics can be produced and manufactured from several well-established bacterial and yeast expression systems including:
- E. coli BL21
- E. coli Stbl3
- Saccharomyces cerevisiae
- Pichia pastoris
DNA/gene synthesis and vector construction as well as transfection and clone selection can all be accomplished by our experienced cell line development team.
R&D Protein & Plasmid Generation
We have one of the largest dedicated R&D small-scale protein and plasmid production groups in the industry. This 200+ team with facilities in Hangzhou, Shanghai and Wuxi produce thousands of high quality biologics for research and lead drug candidate screening each year (click here for more information). Highlights of our R&D grade biologics generation services include:
- High-throughput production and analysis
- Up to gram level production capabilities
- Anerobic and Aerobic microbial expression systems
- Full analytical and product characterization capabilities
- Conduct critical manufacturability and developability studies
- FTE-option for production and analysis of multiple products (ideal as an extension of your research team)
Fermentation (Upstream) and Purification (Downstream) Development
Batch and Fed-batch (including high-density fed-batch) processes and the subsequent downstream purification processes can be developed by our highly-trained teams of development scientists. Folding/Refolding and chemostat unit operation/process step development is also available.
Varying scales for development activities can be conducted using our standard platform or we can develop customized processes for plasmid DNA, antibody fragments, large peptides and fusion and recombinant proteins.
Multiple Bioreactor scales and capacity including 1 L, 3 L, 5 L and 10 L
- Early stage (1 – 20 mg scale)
- Small scale (20 – 1,000 mg scale)
- Process integration (500 mg – 5 g scale)
- Scale-up and pilot production (10 g– Kg scale)
Other Key CMC Development activities:
We have conducted over 220 different integrated DNA to IND programs for our clients. All of these programs (biologics produced from mammalian cell culture) required our in-house single-source CMC development efforts. In addition to the teams established in Hangzhou, our large experienced existing teams in Shanghai and Wuxi can also support products produced from microbial expression platforms. These services include:
- Full analytical development and reference standard characterization (click here for more information )
- Formulation and drug product development (click here for more information)
- Product and process characterization (click here for more information)
- Regulatory and CMC dossier writing support (click here for more information)
Non-GMP/Pilot and GMP Manufacturing
(Non-GMP/Pilot production available Q2 2020 and GMP Manufacturing available Q4 2020)
This multi-purpose/multi-product facility can produce high quality (HQ) plasmid DNA and diverse types of protein biotherapeutics for IND-enabling toxicology studies or other preclinical and CMC development activities at various scales. Site features include:
- 500 sq. meters HQ suites
- 10-50L scale fermenters
- Process scalability and robustness evaluation
- Scale-up development studies
- Large-scale process or batch record verification / qualification
We have designed and constructed our microbial-based large-scale manufacturing facilities based on U.S., EU and Chinese cGMP requirements. The site will take advantage of our world-class quality system that has already been established and audited by the U.S. FDA and EMA in our Wuxi manufacturing facilities.
- 3,000 sq. meters GMP clean room suites
- Up to 4 x 500 L + 1 x 2000 L fermenters
- State-of-art downstream equipment, versatile to tailor for different products
GMP Manufacture (Fill & Finish) of Drug Product
Dedicated fill and finish suites will be constructed in Hangzhou but we can also support drug substance produced from the Hangzhou site in any of our existing Drug Product manufacturing facilities. Click Here for more information
Case Studies for Microbial Expression