Manufacturing standards for components that come into direct contact with patients are exceptionally stringent. For one start-up, we produce plastic components and cartridges used for an innovative approach to cancer immunotherapy. We guarantee compliance with ISO 7 clean-room standards and proper handling of components. In the following case study, we demonstrate which process steps were particularly critical and how we addressed them.
Plastic Components for Innovative Cancer Immunotherapy
High Standards for Plastic Injection Molding in Medical Technology
To prevent product contamination, ISO 7 clean-room production is subject to ultra-strict hygiene regulations.
Since receiving official approval in 2018, an innovative cancer immunotherapy provided renewed hope for leukemia patients who exhausted chemotherapy and other conventional treatment options. This groundbreaking approach genetically modifys the patient’s own immune cells (T cells) to recognize and target cancer cells. The patient’s T cells undergo complex modifications outside the body and are reintroduced into the patient’s bloodstream to actively combat cancer cells — a significant advancement in medical technology.
Genetically Modifying Immune Cells
Our client Lonza uses Nucleofector® technology to open the cell membrane of T cells taken from the patient and introduce genetically modified molecules into the cell nucleus. The process can be used not only for this therapeutic case but potentially in many other life science applications. Electroporation is employed to briefly make the cell membrane permeable. Molecules (DNA, RNA, or proteins, depending on the application) are inserted into the cell nucleus by way of the electrical field. Lonza’s Nucleofector® technology enhances existing transfection methods. Optimized electroporation enables more efficient introduction of genetic material into various cells such as primary cells, previously difficult to transfect.
Plastic Injection Molding under Clean-Room Conditions
To support our client’s Nucleofector® process, we supplied plastic components that met stringent quality specifications, crucial in the manufacturing of the plastic components. For laboratory applications, we produce non-GMP products meeting ISO 8 clean-room standards. For components intended for therapy, we were required to meet GMP and ISO 7 standards due to the heightened risk of contamination which could lead to secondary infections in immunocompromised patients. Our clean-room experts meticulously ensured compliance with all standards and protocols to maintain the highest levels of safety and efficacy.
Multi-Component Injection Molding Expertise
The production of individual injection molding tools enables RKT to execute complex manufacturing processes.
We implemented two-component injection molding processes to manufacture the required plastic combinations. Transparent, non-conductive plastic was injected into the mold, followed by a conductive plastic that facilitated the application of current pulses. Conductive plastics pose specific challenges. Special injection molding processes must be developed to assure proper conductivity, and the tools require increased maintenance and care due to increased tool wear caused by the material.. Another challenge involved integrating metal pins in the product as required in cuvette manufacturing to act as connectors for connectivity to external power-supplying devices. These pins had to be precisely positioned within the mold to be effectively overmolded in the injection molding machine. Various components of different shapes and the liquid capacities were produced.
Incorporating metal pins onto the nucleocuvette to enable the supply of power for the treatment of blood cells can be particularly challenging.
Blistering with Foil and Sterilization
After molding, the parts were assembled into the finished product and blister-packed in primary packaging using a specialized film. Because the components were to be sterilized directly this primary packaging, the film needed to be impermeable to contamination while permeable to sterilization gases. This dual requirement ensured both the integrity and sterility of the final product for our client.
The component is blister-packed with a film to protect it from contamination.
Transfer to Industrial-Scale Production
Supporting a start-up from inception to success is what we do. By being engaged early in the process, we can help optimize and tailor designs of prototypes to maximize their suitability for plastics. Our goal is to refine innovations for seamless transition to full-scale production. We offer recommendations on appropriate plastic materials and solutions that enhance manufacturing feasibility and efficiency. Our ongoing support is here to assist you from concept through to production of whatever volume is needed.