Enzene to Launch Continuous Manufacturing Technology at CPHI Milan 2024

Communication between the manufacturing plant and retail stores. | Image Credit: © Cagkan - © Cagkan - stock.adobe.com

The contract development and manufacturing organization (CDMO), Enzene, will be launching its new fully-connected continuous manufacturing platform for biologics at the CPHI Milan show, being held from Oct. 8–10, 2024 in Milan, Italy. The EnzeneX 2.0 is a patented platform that provides uninterrupted processing from perfusion to final drug substance.

The technology uses high titer clones to improve productivity and target protein concentrations, streamline production, and mitigate risks associated with batch-to-batch transfers. The platform also boosts cell productivity by leveraging optimized cell media. Process analytical technology is used to enable real-time monitoring and control quality.

“Enzene continues to lead the industry in launching innovative approaches to maximize product yield while minimizing COGS [cost of goods]. Our latest innovation in fully connected continuous manufacturing can be tailored for a broad range of modalities and media formulations to boost cell productivity and efficiency,” said Himanshu Gadgil, CEO of Enzene, in a press release. “Lower operational costs and higher productivity can enable up to 50% reductions in overall production cost per gram, and we are on target to achieve a game-changing benchmark by 2025. We expect that our FCCM [fully connected continuous manufacturing] will be able to deliver 40 kilograms per thousand-liter batch at $40-per-gram.”

EnzeneX 2.0 can also reduce equipment footprint compared to fed-batch systems, according to the company. It can handle clinical-phase current good manufacturing practice supply from 30-L scale. The modular design has variable bioreactor capacity and can take on scale-on and scale-out expansion.

Enzene is launching a new facility in Hopewell, NJ, to be operational in early 2025, that the company said will provide a fully connected service. “Enzene Biosciences is thrilled to establish our manufacturing operations in New Jersey, as it allows us to extend our local manufacturing capabilities to our valued North American clients,” said Gadgil at the time of the facility announcement (2). “We are excited to provide them with access to our cutting-edge continuous manufacturing platform, which enables streamlined and efficient production processes. New Jersey’s highly skilled workforce, state-of-the-art infrastructure, and renowned academic institutions make it an ideal location for Enzene, ensuring that we can deliver exceptional services and support to our clients in the [United States].”

Pharmaceutical Technology® spoke with Gadgil in June 2024 about the benefits of continuous manufacturing of biologics. Gadgil talked about the impact on a company’s cost of goods, and stated, “For example, in a 1500-square-foot cleanroom, we can manufacture in a month currently around 10 kilograms of mAbs [monoclonal antibodies], and we are enhancing that platform where we should be able to manufacture on 40 kilograms of mAbs.” Gadgil continued, “So, one of the biggest advantages of continuous manufacturing is cost of goods, because the operational cost is much lower than the conventional manufacturing, [because] the footprint is more compact, and at the same time, the productivity is also very high.” He also said, “Because when you do perfusion, you get significantly higher cell densities almost five to 10 times higher cell densities than the conventional fed batch” (3).

Enzene can be found at CPHI Milan at stand 5D63, Hall 5.

References

1. Enzene. Enzene Launches EnzeneX 2.0. Press Release. Oct. 4, 2024.
2. Choose New Jersey. Enzene Biosciences Expanding to New Jersey with $50M Investment in Bio Manufacturing Plant. June 15, 2023.
3. Haigney, S. Continuous Manufacturing and Cost of Goods (BIO 2024). PharmTech.com. June 5, 2024.