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Supply and Packaging
Labeling, packaging, certification, storage and distribution of clinical and commercial material, run alongside manufacture.
After batch release
A clinical batch that has passed release still has to be labeled in the right languages, packaged in the right study configuration, certified for the market it is going to, stored at the right temperature and shipped to sites that may be on three continents. Each step is routine, but delays crop up in the handovers between suppliers.
Running those steps alongside manufacturing is worth two to three months, and the time savings come from not waiting for a handover.
Clinical supply
Phase I through Phase IV, open-label and blinded, for more than 260 clients since 2022.
The clinical supply center sits in the Shanghai Waigaoqiao Free Trade Zone with both bonded and non-bonded warehousing, within an hour’s drive of two international airports. Storage is temperature-controlled from 15–25°C controlled room temperature through 2–8°C cold, −20°C freezer and −40°C and −80°C refrigeration, with cold-chain transport, clinical site delivery, and returns and destruction handled in the same operation.
A network of fourteen global depots spans North America, Europe, Asia Pacific, South America and the Middle East, reaching twenty-five countries and areas. Since 2022 we have labeled and packaged more than 1,600 batches and made more than 6,200 shipments into the US, Europe, China and other major markets.
EU Qualified Person certification is done in-house. QP certification is a requirement for any investigational medicinal product used in a European study. It is run from our Munich operation inside the same contract, with release in one to two days once a project is on our MIA Annex 8, and twenty to thirty days if it is not.
Packaging and labeling
Trial designs have become harder to package. Packaging and labeling configurations are developed for adaptive designs, multiple arms and blinding.
We handle complex kitting, walleting and blinding configurations, and specialty clinical labeling formats including booklet and multi-panel labels for multi-language studies. Primary packaging covers bottle, blister and sachet for oral products, with open-label and double-blind labeling.
Comparator sourcing runs from the same team.
Commercial supply
At the transition from clinical to commercial supply, a change of partner means re-establishing the packaging configuration, the artwork and the distribution route with an organization that was not there for the clinical work.
At WuXi AppTec, commercial manufacture runs on the same lines and under the same quality system as the clinical batches that preceded it, for small molecules, peptides and oligonucleotides.
The month between release and first patient
Everything after batch release is routine work: labels, cartons, certification, a courier. Running these alongside manufacturing saves about a month in getting to first patient dosing.