Issue link: https://www.e-digitaleditions.com/i/1373953
Pharmaceutical Technology BIOLOGICS AND STERILE DRUG MANUFACTURING EBOOK 2021 47 "NFC technology integrated with secondary pack- aging can wirelessly communicate with a patient's NFC-enabled smartphone to provide updates for the patient on when and how much of their medication to take," adds Vercruysse. In addition to monitoring patient adherence, smart packaging technologies help track the stor- age conditions of a package to ensure product safety and stability. "NFC technology can also transmit in- formation about the package such as 'factory sealed' or 'opened,' and can contain unique identifiers for authentication and tracking," says Vercruysse. Time- temperature indicators in labels can provide clear evidence if a temperature-sensitive medication has been stored in conditions outside the set parameters of the trial. Other chemical or biosensors can be used to determine the chemical and biological integrity of the product and to alert doctors and patients if the drug is unsafe to administer, says Vercruysse. Cold-chain and package integrity For biologic drugs, cold-chain storage and transporta- tion are typically crucial parts of the packaging design. Although indicators could warn a patient of potential damage to a product, the aim is to maintain the cold chain with a package that arrives undamaged. Tech- nologies for real-time tracking can monitor condi- tions such as temperature, humidity, and location and can alert distributors to take action before a package's conditions are compromised (1). In addition, packag- ing should be carefully designed for cold temperatures. For example, it is important to consider how the ma- terials and adhesives used in packaging as well as any tamper-evident seals will behave in cold temperatures, reports Almac Clinical Services (2). "The packaging materials must be able to maintain their structural integrity at low temperatures, pro- tecting the product within from damage," adds Ver- cruysse. "Labeling must also be able to withstand low temperatures and moisture to ensure the information they convey remains legible. Innovation is happening all the time to enhance the properties of packaging materials and inks to achieve these goals." The growing pipeline of biologics drugs has in- creased the need for cold chain capabilities. "We see this trend continuing, not only because of vaccines, but also because of more large-molecule and personal- ized medicines coming to market," says Brian Keesee, vice-president and general manager of global clinical operations and supply at PCI Pharma Services. Other packaging trends to consider Another trend is late-stage customization. "Keeping late-stage customization strategies in mind when designing patient kits and labeling helps ensure the end process is successful," says Keesee. Late-stage customization strategies are supported by just-in-time manufacturing concepts applied to packaging, which allow materials to be packaged and labeled just before shipping (3). Labeling is a crucial part of packaging clinical trial materials. "Labels for clinical trial packaging require the same degree of batch-to-batch consis- tency demanded from drug raw materials," says Berrón. "Label consistency needs to be maintained across all batches, which could be printed over time and across multiple facilities. Lack of consistency, even in secondary packaging, carries the risk of bias that could inadvertently affect the trial." FDA requires serialization of labeling for clinical trial materials, adds Thassu. "The most important consideration for serialization is protecting dose anonymity in a blinded or double-blinded clinical trial. To be truly blinded, a single label lot would