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44 Pharmaceutical Technology BIOLOGICS AND STERILE DRUG MANUFACTURING EBOOK 2021 P h a r mTe c h . c o m Operations C ontract packaging organizations for clinical trial materi- als are increasingly handling biologic drugs, which are typically delivered by injection and have more stringent packaging requirements than other drug forms. In ad- dition to the shift to biologics, the trend to direct-to-patient shipping affects how materials are packaged and makes tracking even more im- portant. Careful consideration of primary packaging materials, kit de- sign, and distribution is crucial for optimizing packages that balance user requirements, protection of drug product quality, and efficiency. "The shift to parenteral delivery impacts both primary and second- ary packaging systems for clinical trials," says Claudia Berrón, se- nior vice-president of Clinical Services at Avantor. Parenteral drugs are shipped as liquid doses that require cold-chain distribution or as lyophilized dosage forms, which require packaging for optimal reconstitution at point of care, explains Berrón. She explains that primary parenteral packaging (e.g., prefilled syringes, autoinjector pens, or vials) should be protected by the secondary packaging to prevent breakage during shipping. Packaging should also incorpo- rate patient-friendly and child-resistant features. Kit design When designing a kit, it is crucial to understand how it will be used by investigators, says Fiona Geiger, vice-president of client services at Yourway. "The more complete understanding that the kitting pro- vider has about what materials will be necessary and in what order they will be used, the better the solution. Communication with spon- sors and ideally the sites themselves can make a huge difference." Packaging Biologic Drugs for Clinical Trials Jennifer Markarian Contract packaging organizations packaging biologic drugs for clinical trials use technologies that meet the unique requirements of each study. LIGA258 - STOCK.ADOBE.COM