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Home | Services & Solutions | Oligonucleotide | Development & Manufacturing | Drug Product
We support parenteral drug product development and manufacturing for oligonucleotide drugs from preclinical to commercial stages.
Our state-of-the-art injectable formulation development and manufacturing platform is located at Wuxi City site and Shanghai Waigaoqiao site in China. It provides integrated R&D and manufacturing solutions for all synthetic molecules, including small molecules, oligonucleotides, peptides and complex chemical conjugates. To meet various needs from our global customers, we also have high potency injectable manufacturing line and sterile lipid nanoparticle (LNP) plant.
Our formulation development & analytical teams have rich experience in injectable drug development from preclinical studies through clinical trials to commercial launch, with 60,000+ characterization tests yearly.
We support a variety of dosage forms and filling formats for injectable drugs with 5 production lines, featuring fully enclosed isolation systems and automated filling lines. Our total production capacity is 70 million parenteral units per year.
Drug Types
- Oligonucleotide
- Synthetic conjugate
Dose Forms
- Solution
- Suspension / Emulsion
- Lyophilized powder
- Advanced formulations (e.g., Liposomes, Lipid Nanoparticles, Nano Particles)
Filling Formats
- Vial
- Prefilled syringe
- Cartridge
Sterilization
- Sterile filtration
- Heat-moist sterilization
- Irradiation
Highlight in Parenteral Formulation and Manufacturing
- Flexible batch size
- Organic solvent compounding & hydrophobic filtration (e.g. DMSO)
- Extreme low fill volume
- High viscosity mixing and filling
- Elevated or cold temperature mixing
- Dissolved oxygen and headspace control
- Sterilization methods
– Sterile filtration / Moist heat sterilization
– Irradiation
We are experienced in all stages including multiple phase III and commercial projects with 100% success rate of PPQ campaigns.
Our formulation teams are supported by more than a thousand of scientists and state-of-the-art facilities at our integrated drug product R&D and manufacturing facilities at Wuxi city and Shanghai Waigaoqiao site in China. Both two sites are within 2-hour drive to our oligonucleotide API site in Changzhou, providing an integrated oligonucleotide API and formulation development and manufacturing solution.
Sterile Injectable
Our injectable formulation development teams consist of experienced scientists, supporting various dosage forms – solution, emulsion/suspension, lyophilized powder and liposome in vial, pre-filled syringe and cartridge.
Our injectable manufacturing line is wholly automated in a full isolation system, designed to minimize human interventions and eliminate contamination to ensure high product quality. Read more.
Lipid Nano Particle (LNP) Platform
Our LNP platform features novel multi-channel micro-mixer for its robust scalability and reproducibility. Lipid nanoparticle with various assembly structures can be assembled by developing formulation and controlling process. Projects can be quickly scaled up from R&D to GMP clinical and commercial manufacturing phases utilizing our strong LNP technology platform and proprietary technology experience.
It is worth mentioning that the services of synthesizing and manufacturing of oligonucleotide and specific functional lipids (such as ionizable lipids and PEGylated lipids) can be also provided by us. In conclusion, WuXi STA LNP platform is an end-to-end platform, which integrates CMC development and manufacturing services for drug substance, drug product and analytical support. Read more.
High Potency Injectable Drug
Our high potency sterile injectable manufacturing line is situated at the drug product site in Wuxi City, China. It operates with an Occupational Exposure Limit (OEL) of 10 ng/m3.
The fully enclosed isolation systems and automated filling machines work together to minimize risks of microbial contamination and cross-contamination. Equipped with two 20m2 lyophilizers, the line supports the production of liquid and lyophilized vials in various specifications.
With the capability to fill up to 200 units per minute, this line boasts an annual capacity of over 12 million units.
Lipid Nanoparticle Technology
Lipid Nanoparticles (LNPs) offer a novel drug delivery system for oligonucleotide drugs. They help overcome delivery challenges such as protection against serum nucleases, eliciting an immune response, and targeting specific cells or tissues.
Overcome delivery hurdles and expedite your oligonucleotide drug projects with WuXi TIDES’s comprehensive LNP services. Our offerings span lipid discovery, formulation and process development, analytical development, and manufacturing with different scales.
- Novel lipid design and synthesis at any scale
- Robust scalability and reproducibility (starting from 5 ml)
- Small particle size (80~100nm) and narrow PDI (<0.10)
- Integrated formulation development, analytical, in vitro/in vivo evaluation
- Flexible scale, ranging from 10 L to 50 L per sub-batch
Formulation Development
The parenteral pre-formulation, formulation and analytical teams are located at Shanghai Waigaoqiao site and Wuxi City site, supporting parenteral projects from preclinical studies through clinical trials to commercial launch, spanning all synthetic molecules, including small molecules, oligonucleotides, peptides and complex chemical conjugates.
In addition, we also have high potency injectable labs with OEL limit of 10 ng/m3.
We support all types of dosage forms and filling formats.
Manufacturing
The state-of-the-art parenteral drug product manufacturing facilities are in Wuxi City drug product site in China and will be expanded to our Couvet site in Switzerland and Middletown Delaware site in the US.
We support various dosage forms and filling formats at any scale from preclinical to commercial manufacturing. We have 5 production lines are featuring fully enclosed isolation systems and automated filling lines, and we support high potency injectable drug product.
Clinical Supply Service
Our Clinical Supply Services (CSS) provide a fast, flexible and reliable supply of materials for your clinical trials at any stage (from Phase I to Phase IV). Utilizing our integrated CMC platform which includes services for both drug substance and drug product development, we offer our clients a seamless transition from process development and pre-formulation studies to drug product manufacturing, packaging, labeling and distribution to clinical sites globally. To add, our clinical supply services support both oral and parenteral drug products with various dosage forms and packaging solutions.
In 2023, our CSS teams supported both open-label and blinded studies from phase I to IV and executed hundreds of clinical protocols.
