Process development
Optimize your biologic processes with Enzene's integrated process development solutions. From upstream cell culture to downstream purification, we provide comprehensive CDMO services to maximize your biologics production.
Process development is the cornerstone of efficient and cost-effective biologics manufacturing. It encompasses the optimization of both upstream and downstream processes to maximize yield, ensure product quality and accelerate time to market. Key aspects of process development include:
- Upstream process development: Focusing on the initial stages of biologic production involves cell line selection and optimization of culture media, feed and bioreactor operation to maximize yield and quality. High-performing cell lines are selected with optimal expression, while chemically defined media formulations enhance growth and productivity. Bioreactor conditions, including pH, oxygen, and feeding strategies, are finely tuned for efficient large-scale production.
- Downstream process development: The purification and isolation of target biologics from the cell culture harvest, using techniques like chromatography, filtration and protein refolding (for bacterial origin denaturing format molecules) to ensure purity and quality.
- Scalability: Developing robust processes that can be seamlessly scaled from R&D to clinical production, maintaining efficiency and product quality throughout.
- Process characterization and Process validation: Multi-factorial interaction studies to evaluate and fine-tune both upstream and downstream processes, identify bottlenecks and incorporate a control strategy, ensure consistency and adhere to regulatory requirements.
Comprehensive process development solutions
Enzene offers a full spectrum of process development solutions designed to optimize the production of your biologics innovations.
Our comprehensive services, including our fully-connected continuous manufacturing™ (FCCM™) platform EnzeneX®, help ensure a seamless and efficient path to market for your biologics.
What modalities can we work with:
The value of Enzene’s process development solutions
Enzene is at the forefront of developing and optimizing bioprocesses to maximize the production of your biologics. From cell line development and upstream processing to downstream purification, we provide:
- Our patented and validated fully-connected continuous manufacturing™ platform, EnzeneX® that enables us to significantly reduce your cost of producing complex biologics and monoclonal antibodies (mAbs).
- Customized solutions for development of a new process or the optimization of an existing one.
- Expertise to meet your specific requirements at any stage of development, from early-stage research to commercial production.
Why partner with Enzene?
We are a global Continuously Innovative Development and Manufacturing Organization (CIDMO), dedicated to changing the paradigm by which affordable biologic and biosimilar medicines are brought to market. Since Enzene’s inception, our innovative agility has enabled us to continually introduce transformative processes in biologics manufacturing that significantly increase product yields of complex biologics and monoclonal antibodies (mAbs) while reducing the manufacturing footprint and the cost of production.
Game-changing innovation is only the beginning, though. We are Enzene, and that means that our values of innovation, entrepreneurship, respect, candor, excellence, and integrity underscore everything we do from project management and communications to teamwork and ideation. To us, true partnership is about driving biotech innovation while doing so in a way that develops long-lasting trusted partnerships.
The most advanced innovation is only one step away.
From discovery to commercial supply, an Enzene partnership brings a new way of thinking about biologics.
Let’s discuss your challenge or project.