Ask the Expert: Emerging Trends in Drug Assembly and Packaging

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Thomas Gabriel (director of strategy and business development at Fujifilm Diosynth Biotechnologies, FDB) emphasized patient agency in his 15 April 2020 “Ask the Expert” presentation on innovations in finished-goods solutions. Facilitating self-administration significantly benefits patients with chronic conditions, and new delivery technologies are making drug products increasingly easy to handle and with increasingly accurate dosing. Gabriel explored how single-use autoinjectors and prefilled syringes, needle shields, on-body delivery systems, and digital monitors are improving drug-delivery safety and efficacy while enabling patients to take charge of their own health.

Gabriel’s Presentation
Nobody chooses to develop a chronic condition. Thus, finished-goods solutions should enable patients to take their medications and then disengage from their diseases as much as possible to go about living life. Emerging drug-delivery formats are making that happen. Many products still come in vials, which can hinder patients’ ability to take medications as prescribed. But the biopharmaceutical industry now is finding ways to adapt vials to single-use autoinjectors, facilitating self-administration. Prefilled syringes and autoinjectors are equally attractive because they ensure secure and accurate dosing in a convenient format. Needle shields are improving the safety of ready-to-use devices by reducing third-party sticking episodes and preventing accidental contamination. Shields also can reduce “needle phobia” and thereby encourage patient compliance.

Until recently, the industry standard has been to load ready-to-use devices with doses <2.25 mL. But companies now are designing self-administration methods for larger volumes. On-body delivery systems are of particular interest. Instead of visiting a hospital or treatment center for an intravenous infusion, a patient can apply a patch device and press a button that prompts slow-flow delivery of drug product from a medicinal cartridge. Such devices enable comfortable and effective delivery of 2-mL to 10-mL doses, even for high-viscosity formulations. That significantly increases patients’ control over how and when they administer their medications.

The future of drug delivery lies in digitalization. The World Health Organization (WHO) observes that medicines will not work if patients will not — or cannot — take them. But digital developments are helping users to set alarms on their smart devices to encourage timely preparation and administration of their medications. WHO studies indicate that such capabilities alone can increase patient compliance with a therapy regimen by 2–22%. Building on such applications, drug-delivery devices increasingly are equipped to monitor system conditions and report those data to connected smart devices. Delivery devices can report when patients administer their medications and how much they are dosing each time. In some cases, users can send data directly to an application or database so that they can review their progress later with healthcare providers.

Promoting patient agency is critical to successful treatment of chronic conditions. By helping patients optimize self-administration, single-use technologies, digital health tools, and increased medical-device connectivity together can hasten truly individualized medicine and promote positive patient outcomes.

Questions and Answers
How can FDB help to develop their drug-delivery systems? FDB specialists understand the needs of particular patient populations. Based on dosing volume and frequency, our teams can help companies select appropriate finished-good solutions and qualify delivery devices. We also can assist in designing, establishing, and executing manufacturing processes tailored to those solutions.

Can FDB assist in developing packaging configurations? Our teams have considerable experience with designing packaging configurations to protect delivery systems and embed relevant documentation such as patient leaflets. We also have expertise in testing whether packaging solutions meet relevant protection requirements.

Can your company support commercial manufacturing? FDB offers manufacturing solutions across a product’s entire life cycle — from early product development to commercial launch — and has significant experience transferring products and processes into our own manufacturing platforms. We can assist with drug and patient profiling, and we have plants that produce finished-goods solutions for companies across the globe. We are happy to help in any of these contexts and are eager to support product launches in different countries.

More Online
The full presentation of this webcast can be found on the BioProcess International website at the link below.

Watch the full webcast now.

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