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Packaging, Labeling, and Supply
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.
Full lifecycle management in one operation: global comparator sourcing, primary and secondary packaging, labeling, storage, distribution, cold-chain transportation, delivery to clinical centers, and returns and destruction.
The supply center
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: ambient 15–25 °C, cold 2–8 °C, freezer −20 °C, and refrigeration at −20 °C, −40 °C and −80 °C.
The depot network
A network of fourteen global depots spans North America, Europe, Asia Pacific, South America, and the Middle East, reaching twenty-five countries and areas.
Named depots: Shanghai, China; Singapore; Melbourne, Australia; Hillsborough, New Jersey; Louisville, Kentucky; Middletown, Delaware, ready in 2026; and Freiburg, Germany. Several operate as partnership depots.
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
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.
Packaging covers walleting, kitting, blinding, and the assembly of bags, cartons and wallet cards, plus light protection packaging and child-resistant packaging. Primary packaging covers bottle, blister, and sachet for oral products.
Labeling covers design and printing in single panel, two panel, booklet, transparent and special formats, with shelf-life extension labeling, and open-label and double-blind options for multi-language studies.
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.
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, and six to eight months across a first clinical program when the whole CMC platform is used.