Boosting Australia’s Good Manufacturing Practice Capabilities For Medicinal Products
Participants of the REDI-supported CBE GMP programs have found enormous benefit from the specialised training offered. Pictured far right, CBE Director Steve Williams.
The COVID-19 pandemic and the search for a vaccine shone a spotlight on sovereign capabilities in the medical technology, biotechnology and pharmaceuticals (MTP) sector in Australia, underscoring the critical importance of R&D of innovative technologies to address complex human health challenges. The pandemic also highlighted the need for Australian-based manufacturing and a robust supply chain to ensure the continuous provision of medical products.
Recognising the role of Good Manufacturing Practice (GMP) in supporting the healthcare sector, MTPConnect’s REDI initiative had pinpointed GMP competency as a key skills gap in its needs assessment.
To address this gap, REDI engaged the Centre for Biopharmaceutical Excellence (CBE) to form a strategic partnership with ARCS Australia, CBE Pure Solutions, Merck Australia, Translational Research Institute and University of Technology Sydney to launch two different GMP training programs. The programs are specifically designed to provide participants with a real-world perspective and to enable the interpretation and application of GMP in practice.
GMP describes a set of principles and procedures that when followed helps ensure that therapeutic goods produced and tested are of high quality. Australian-based manufacturers of medicines and biologicals are required to hold a licence to manufacture, with different codes of GMP for medicines, human blood and tissues as well as medical devices. GMP also extends to legal components covering responsibilities for distribution, contract manufacturing and testing and responses to product defects and complaints.1
Regulatory oversight by bodies like the Therapeutic Goods Administration (TGA) ensures manufacturers uphold these standards, fostering consumer confidence in the safety and efficacy of therapeutic products in the Australian market.
The REDI initiative identified a shortage of GMP-competent staff
Many Australian SMEs require GMP skills for R&D and product development and the REDI initiative identified a shortage of GMP-competent staff. This is a skills gap for new hires, who need to understand how to be GMP compliant, and for senior staff, who need to maintain competence and knowledge of the latest GMP guidance from the many regulatory bodies worldwide.
As consortia lead, CBE brings strong technical credentials, from consulting services across the biopharmaceutical sector and GMP-related enterprise training. One of the programs – CBE’s REDI GMP Uplift Essentials program – is a five-day equivalent course designed to upskill those new to the sector in the core principles of GMP. It takes the theoretical into practice through experiential learning.
CBE Director Steve Williams said the GMP Uplift Essentials program builds experience for those early in their GMP career journey, giving them foundational yet practical skills.
“Growth across our biopharma sector presents both an opportunity and a challenge for companies trying to find staff. Start-ups and small enterprises face a real challenge to find GMP-trained staff and they aren’t large enough to have their own training division.
“These REDI-supported training places are making a difference for start-ups and SMEs transitioning from development to manufacturing and enabling them to incorporate a compliance structure,” said Mr Williams.
Aiming to equip its workforce with immediate practical skills, EnGeneIC has been training its staff through CBE’s REDI GMP Uplift Essentials program.
Named by Australian Financial Review as the most innovative company in healthcare in 2022, Sydney-based clinical-stage biopharmaceutical company EnGeneIC has developed ‘EDV (EnGeneIC Dream Vector) technology’ – a nanocell platform enabling targeted delivery of cancer treatments to be far more potent and less toxic, while also stimulating an anti-tumour immune response. This technology has the potential to revolutionise cancer treatment – making the process simpler, quicker and more effective than existing options.
Growing organisations hampered by a shortage of GMP-trained staff
Yet, like many growing organisations in the life sciences sector, EnGeneIC’s efforts are being hampered by a shortage of staff trained in GMP, which impacts the company’s growth and scalability.
Recognising this, EnGeneIC found REDI’s funded program a great opportunity not only for its own benefit, but also to help bridge the sector-wide skills gap in the industry and to enhance medical product sovereign capabilities across Australia.
EnGeneIC Senior Vice-President of Manufacturing, Juan Dux-Santoy, said the program has been extremely helpful in upskilling staff and introducing them to microbial controls and aseptic techniques – particularly as the company looks to scale up its technology.
“The benefit of this training is enormous for us, since it helps us to understand the critical parameters and steps in our manufacturing process and action any issues deficient in GMP,” he said.
GMP training for EnGeneIC staff – particularly valuable at a pivotal moment
Mr Dux-Santoy added that the training has been particularly valuable at a pivotal moment in EnGeneIC’s growth, as it designs a new manufacturing facility. As such, learning about clean room areas and layout optimisation – essential features of any facility manufacturing sterile medicine products – has proved very timely.
“Through the GMP Uplift Essentials program, the team has not only gained an understanding of what will be required in the new facility, but has also already implemented changes to existing workflows, in relation to gowning processes, record-keeping and microbial controls,” he said.
Participating in the GMP Uplift Essentials program has underscored the immediate and practical impact training can have on workforce development for EnGeneIC, as well as contributing to the team’s ongoing success and innovation in cancer treatment.
In December 2023, the company was granted US Food and Drug Administration (FDA) ‘Fast-Track’ designation for its Novel Armed Nanocell Drug Conjugate (ANDC) pancreatic cancer therapeutic and is now entering Phase IIa clinical trials in Australia and the US in patients with intractable, low survival cancers, including patients with metastatic pancreatic cancer.
1. Therapeutic Goods Administration: Good Manufacturing Practice Overview