The significant advantages it offers include:
Large reduction in COGS: By 2025, EnzeneX 2.0 expects to produce 40 kg/1000 L batches at $40/gram, redefining FCCM economics. Lower operational costs and higher productivity can lead to up to 50% reductions in overall cost per gram.
Higher Titer Clones: EnzeneX 2.0 maximizes protein yield per cell line with superior productivity. FCCM can achieve up to 10x increases in product yield compared to fed-batch.
Optimized Cell Media: Tailored media formulations enhance cell productivity and efficiency.
Process Analytical Technology (PAT): Enabling real-time monitoring and control for consistent quality and optimized processes.
Enhanced Product Quality: Continuous extraction from the bioreactor minimizes exposure to harmful metabolites and proteolytic enzymes, resulting in higher product quality, particularly for less stable or challenging proteins.
Greater Sustainability: The reduced equipment footprint allows for smaller facilities and up to 50% reduction in carbon emissions.
Enzene Biosciences is set to showcase its latest innovation, EnzeneX 2.0, at CPHI Milan, offering its new fully connected continuous manufacturing (FCCM) platform. With promises of lower production costs, enhanced productivity, and greater sustainability, this breakthrough aims to revolutionize biologics manufacturing and set new industry standards. OSP spoke to Enzene’s Russell Miller to find out more.
What key innovations or new products will your company be showcasing at CPHI Milan this year, and how do they address current industry challenges?
At CPHI this year, we’re Introducing EnzeneX 2.0, our latest breakthrough in fully connected continuous manufacturing (FCCM). It offers a transformative approach to continuous manufacturing, delivering significant economic, productivity, quality, and sustainability benefits.
An advancement on traditional fed-batch processes, FCCM offers uninterrupted processing from perfusion to final drug substance, streamlining production and minimizing risks associated with batch-to-batch transfers.
What sets your company apart from competitors in the pharmaceutical industry, and what value do you offer to your customers?
Enzene continues to be the innovative leader in the CDMO industry, first pioneering the fully connected continuous manufacturing (FCCM) technology and now launching EnzeneX 2.0, a further evolution in biologics manufacturing.
The biologics manufacturing industry is in transition from traditional fed-batch processing to continuous manufacturing of varying degrees. For some companies, this means only using perfusion bioreactors or running hybrid-continuous processes. With EnzeneX 2.0, the entire operation from perfusion to final drug substance manufacturing is seamlessly connected, offering significant advantages over traditional fed-batch processing.
EnzeneX 2.0 is characterized by higher titer clones, optimized cell media, and Process Analytical Technology (PAT). These benefits translate to an accelerated time-to-market, increased production yields and COGS reductions.
Our commitment to innovation and continuous optimization further differentiates us, as we strive to reduce monoclonal antibody production costs to below $40 per gram by 2025.
