Pharmaceutical Technology - May 2021

Pharmaceutical Technology - Biologics and Sterile Drug Manufacturing - May 2021

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46 Pharmaceutical Technology BIOLOGICS AND STERILE DRUG MANUFACTURING EBOOK 2021 P h a r mTe c h . c o m "Items must be stored within the kit in a way that minimizes the risk of breakage or contamination," adds Pieter Vercruysse, commercial director at Tjoa- pack. "They must also be designed in such a way that the entire product [such as a syringe or autoin- jector] can be combined quickly and effectively with minimal manual input." Other factors to consider include package dimen- sions and cold-chain requirements. "Kits ultimately have to be packaged in shipping containers, and these have fixed, standard dimensions. So, when you are preparing kits that will need to end up in a 12-in. x 12-in. shipper, you have to make sure that you are sourcing ancillary supplies (e.g., syringes) with an eye on these dimensions and repackaging materials to fit into these constraints, or costs can skyrocket," notes Geiger. She adds, "Many drug products re- quire temperature-controlled shipping and storage, but ancillary materials do not." If a kit's ancillaries increase the size of a unit, it may be better to ship a separate ancillary kit that doesn't need to be kept cold. When shipping direct to a patient's home, con- venience might be more important, however. Decentralized clinical trials occur in a partici- pant's home rather than at a central clinical site. "Direct-to-patient (DTP) and direct-from-patient (DFP) services have really transformed what materi- als are needed for a study. We've seen more demand for more patient-centric kits," says Geiger. "In trials at clinical sites, ancillary items are stocked, and drug product materials can be kept in storage for a pa- tient for multiple visits, but for visits at the home, you need to package not just the drug product but also the means to administer it, as well as ancillary mate- rials or medical equipment. In addition, return pack- ages need to hold patient samples and other items such as used wearable tracking devices or completed questionnaires. DTP/DFP is new, and the packaging is specific for each unique study." "The trend of moving the center of clinical trials to patient homes drives requirements for primary pack- aging in the form of patient-friendly administration systems," adds Berrón. "For secondary packaging, this shift increases clinical kit complexity: inserts and dividers in top-loaded cartons provide a more logical presentation for the end-users. Personalized therapies, such as CAR-T and gene therapy, will only push this trend further, increasing the requirement for user-friendly clinical kits." Smart packaging "The push in 2020 for hybrid and remote clini- cal trials provided fertile ground for home-based technologies," says Berrón. She suggests that use of patient-monitoring technologies, such as bar- codes that can be scanned by patients with a smart phone, will continue to increase. In addition to barcodes used with smart phones, "smart" packaging uses digital technologies such as labels with radio frequency identification or near-field communication (NFC) tags, to track the package and how the patient uses it. "Patient non-adherence is a prevalent concern in clinical trials and one reason why clinical trial costs are on the rise. Companies are turning to digital so- lutions to overcome challenges and ensure patient adherence," notes Deepak Thassu, vice-president, R&D and regulatory submission at LGM. "Smart packages provide a means of capturing unbiased information on a patient's dosing history. The data can be analyzed to help clinical trial teams better un- derstand patient adherence and exposure to the drug. This dosing information can also be used in coun- seling patients to stay compliant with the protocol." Operations

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