Transforming Tomorrow: EnGeneIC’s Pioneering Journey with GMP Training

General Training July 2023

Transforming Tomorrow: EnGeneIC’s Pioneering Journey with GMP Training


From nanotech breakthroughs to GMP excellence: EnGeneIC’s quest to transform cancer treatment

In the world of biotechnology and pharmaceuticals, where innovation and targeted patient care is critical, the need for skilled professionals and rigorous quality standards is paramount.

EnGeneIC, a clinical-stage biopharmaceutical company, understands this better than most. With their lead product aimed at end-stage pancreatic cancer, EnGeneIC is addressing an unmet need that could potentially change the landscape of cancer treatment. Their groundbreaking work centers around the development of the EDV™ nanocell platform, a revolutionary technology for the targeted delivery of chemotherapeutics and functional nucleic acids in low-survival cancers.

EnGeneIC’s journey, like many pioneering biotech companies, is not without its challenges. One significant hurdle has been the shortage of qualified professionals in the biotech and pharmaceutical sector, particularly those skilled in Good Manufacturing Practice (GMP). However, EnGeneIC has been proactive in addressing this challenge through their investment in the training and upskilling of their current staff.

CBE’s GMP Uplift Essentials program has proven to be a valuable resource in EnGeneIC’s journey. Supported by MTP Connect’s Researched Exchance Development within Industry (REDI) program, the company was able to upgrade the skills of its personnel in GMP. This is particularly crucial as they design a new facility that must fulfil cGMP requirements. Having completed the program, Senior Vice President of Manufacturing at EnGeneIc Juan Dux-Santoy remarked that; “I’ve undertaken many GMP training programs across various countries, but the GMP Uplift program was by far the best and most comprehensive.”

The program allowed their engineers and operators to gain a deeper understanding of critical steps during the manufacturing process and considerations in designing a manufacturing facility. Remarking on this, Mr Dux Santoy said “the benefit of this
training is enormous... it is creating a lot of opportunities for process improvement and product safety.” EnGeneIc’s manufacturing personnel also benefitted from experiencing proper gowning, learning about microbial controls and enhanced aseptic techniques when working in sterile areas. More broadly, Mr Dux Santoy said that the program has helped to “foster a sense of ownership in the manufacturing team.”

Speaking about the program, CBE consultant and GMP Uplift course coordinator Rachel Jensen said “building an understanding of GMP in biotechnology organisations early allows them to build in appropriate layers of quality and rigor during development.
This builds in a robust understanding around their product, processes and testing, which is invaluable as they approach technology transfer and scale up.” The benefits of EnGeneIC’s GMP training ripple far beyond their own company. As a biotech enterprise, their dedication to upskill in GMP training ensures quality is built in - keeping patient health a top priority.