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The Importance of Packaging in the Clinical Trial World

In the summer of 2018, Apellis, a biopharmaceutical company, started a clinical trial for a drug called APL-2 (later formally named Pegcetacoplan) that is designed to treat patients with various chronic illnesses and complement-medicated diseases. I joined this study in the Spring of 2019 as a patient with C3 Glomerulopathy (C3G). The study is still recruiting patients for the study of various illnesses including my own. For some illnesses, the Food & Drug Administration has approved the medication as a proper treatment. There is much packaging that is involved in the clinical trial world and it is vital in helping companies like Apellis continue their research. For the study to go smoothly, medical devices and other products to be protected for the use of patients or medical professionals. The patients and their health must be protected.

Pegcetacoplan is a drug that is taken in liquid form via infusion. This means that the patient will have needles placed at the preferred infusion site. I prefer my infusion site to be the abdomen. Figure A shows the vial that the medicine comes in. Sets of tubes and needles are provided with syringes, adapters, a pump, and, of course, the drug. They also provide sanitary wipes, urine sample cups, cooler for the sample cups, cooler for the medication, and ice packs. The packaging of the individual medical supplies (like the tubes, syringes, and adaptors) has one main goal: to keep the supplies sanitary/bacteria-free. These supplies must last through before and during the infusion. The pump is a different story. The pump (shown in Figure B below) that Apellis provided for the study is a mechanism that slowly feeds the drug through the tubes and into the infusion sight. This infusion takes place two times a week.

The pump is designed to be able to last through the entire study unless damaged during travel or an incident. The pump is designed to slowly feed the medicine out of the syringe and into the infusion site.

There are various metals, polymers, and ceramics used in medical devices and supplies. The way the devices are manufactured makes a big difference in how the medical process goes. A good example of why this is true is how the needles are made and how they are applied. The needle is supposed to sit perfectly perpendicular and be attached to a surface on a butterfly-looking piece of plastic. The piece of plastic sits flush with the epidermis. However. Sometimes the needles are not perfectly perpendicular and lean slightly toward the surface. This can cause more pain for the patient while placing the needle at the infusion sight, as well as more bleeding. There is also the potential for health risks with using certain materials in their manufacturing and packaging. This is why choosing the proper materials requires much caution. It is the job of the FDA to protect the public’s health by ensuring the safety and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The FDA has initiated research efforts to report knowledge gaps in the following areas:

1) Scope and occurrence of metal implant-related adverse health outcomes

2) Impact of anatomical location and device characteristics on immune responses

3) Clinically relevant in vivo and in vitro models for immune responses

4) Optimization of existing in vitro diagnostic tests

5) Clinically relevant in vitro tests and safety limits for corrosion/wear

6) Standardized sampling and analysis of corrosion//wear products in biological tissue/fluid

7) Biomarkers and other tools for screening and monitoring patients

When patients receive medication, it is sent with them in a large cooler case, which can hold the cold for a specific amount of time. This protects the medication from the outside elements and damage. Six medicine vials are placed in a small single wall (not corrugated) white box with the proper labeling and with dividers/spots for each vile. This prevents the vials from clashing into each other and breaking. Sometimes this medicine must be sent in the mail instead of coming home with me when I fly home. This puts the medicine at further risk for damage. However, Apellis sends these cooler cases in a double-wall corrugated cardboard box for extra protection. They also use these boxes to send coolers to and from my residence. When these boxes are sent to my home, they are filled with the necessary items to collect samples for research and send them back. These coolers contain sanitary bags, bubble wrap, and ice packs that we must freeze before sending back the samples. Figure C below shows the box and cooler with the sample collection supplies. Figure D1 & D2 show the types of boxes that are used for the supplies; thin, single-wall, corrugated cardboard box.

In the Spring of 2020, the Coronavirus-19 pandemic began. This heavily affected the clinical trial and the health workers involved. The main areas that were affected were appointments and medical devices. During this time, mainly in 2020, the study directors decided to offer the option of at-home appointments. Most sites, including the one that I visited for my appointments, decided to go with this option. They would send home health nurses from Global Home Health Care to our residence. The nurse would bring all the needed devices such as the EKG device, blood pressure cuff, tubes, and other supplies to draw blood, and anything else related to the study. Protecting all medical devices, medicine, and samples became even more important during the pandemic to protect the health of patients and healthcare workers.

Apellis’s clinical trial is designed to treat patients with various chronic illnesses and complement-medicated diseases. There is much packaging that is involved in the clinical trial world and it is vital in helping companies like Apellis continue their research. It also allows medical devices and other products to be protected for the use of patients or medical professionals. The types of packaging methods used for medical devices in the study play a big role in the safety and cleanliness of any and all materials, patients, and healthcare workers.

References

Safety of Metals and Other Materials Used in Medical Devices. U.S. Food and Drug Administration. https://www.fda.gov/medical-devices/products-and-medical-procedures/safety-metals-and-other-materials-used-medical-devices

(2022 September 29). Our Science - Modulating the Complement Cascade to Develop Novel Therapeutics: Apellis Pharmaceuticals. https://apellis.com/our-science/science-of-c3/

(2021 June 28). Corrugated Box Sizes and Thicknesses Guide. CS Packaging, Inc. https://cspackaging.com/2019/07/18/corrugated-box-sizes-and-thicknesses-guide/

What We Do. U.S. Food and Drug Administration. https://www.fda.gov/about- fda/what-we-do

Our Services. GLOBAL. http://www.globalhomehealthcare.com/our-services/

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