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TIDES Drug Product
Drug substance and drug product can run in the same network and the same country, which removes a border, a customs delay and a second release test between them.
The drug substance to drug product handover
Drug substance and drug product are often made by different companies in different countries. Each batch of API then crosses a border, acquires a transit stability question, is released twice, and arrives with an impurity specification that two analytical groups have to agree on.
The oligonucleotide drug product site at Wuxi City and the API site at Changzhou are in the same province, and the peptide drug product sites sit in the same network. All run under the same quality system and analytical methods, with one release.
Parenteral
Five aseptic filling lines with fully enclosed isolation systems and automated filling, running at a combined capacity of more than 100 million units a year, and producing more than 270 sterile batches annually.
Dosage forms cover solution, emulsion, suspension, lyophilized powder and liposome, filled into vials, prefilled syringes and cartridges. Routes of administration span intravenous, subcutaneous, intramuscular, intrathecal, ophthalmic and inhaled, which matters for oligonucleotides in particular, where intrathecal delivery is common.
Across drug product campaigns to date, PPQ success stands at 100 percent, including multiple Phase III and commercial programs.
High potency, contained
A dedicated high-potency sterile line at Wuxi City operates at an occupational exposure limit of 10 ng/m³, with two 20 m² lyophilizers, filling up to 200 units a minute for an annual capacity above 25 million units. Potent conjugates run on the same platform.
Lipid nanoparticles
Lipid nanoparticles are the delivery system for most systemically delivered oligonucleotides that are not GalNAc-conjugated, and the ionizable and PEGylated lipids are often the harder supply question.
We make both, and the LNP service runs from lipid discovery through formulation and process development, analytical development, and GMP clinical and commercial manufacture, with the functional lipids synthesized in the same organization.
Oral peptides
Oral delivery is among the hardest problems in peptide drug development: instability in the gut, low permeability and poor systemic exposure, often all three. We support oral peptide programs from early feasibility through IND-enabling formulation and GMP clinical supply, typically reaching GMP in six to eight months from the start of feasibility.
Three stages
No border between API and fill line
Keeping the API site and the fill line in one country and one network removes the customs delay, the transit stability question, the second release test and the reconciliation of impurity specifications between two analytical groups.