Process characterization

Optimize your biologic processes with Enzene's comprehensive process development solutions. We offer integrated process development solutions, from upstream cell culture to downstream purification, to maximize your biologics production.

What is process characterization?

Process characterization involves detailed analysis to ensure optimal performance and product quality. Our process characterization enables fine-tuning of both upstream and downstream processes, identifying bottlenecks, integrating control strategies, ensuring process consistency, and meeting regulatory requirements.
We optimize manufacturing conditions to achieve efficient, high-quality, and cost-effective biologics production. It ensures consistent production, minimizes process variability, supports regulatory compliance, enhances troubleshooting, and provides critical process data to guide scale-up.

We support process characterization with studies including:

  • Cell line characterization
  • Culture medium characterization
  • Development and qualification of scale-down Model
  • Risk assessment of unit operations to identify potential critical process parameters
  • Multi-factorial DOE-based interaction studies to identify critical process parameters
  • Chromatography resin and membrane re-use
  • Hold-time of in-process materials and buffers
  • Clearance studies for process-related reagents and impurities
  • Extractable and leachable studies including elemental and nitrosamine impurities
  • Filter validation studies
  • Virus clearance study design and execution

Partnering with Enzene for process characterization

Partner with Enzene’s process characterization specialists to elevate biologics manufacturing efficiency, quality, and cost-effectiveness. Through comprehensive analysis of upstream and downstream operations, we fine-tune processes, minimize variability, and uphold stringent regulatory standards for optimized production. Enzene’s patented and validated fully-connected continuous manufacturing™ (FCCM™) platform, EnzeneX™, reduces the cost of producing complex biologics and monoclonal antibodies (mAbs). As a global CDMO and biosimilar developer, we are dedicated to bringing trusted and affordable medicines to market quickly. Our fully integrated services and biosimilars pipeline is designed to cater to every project’s needs.

The future begins now

Your biologic deserves the most technologically advanced manufacturing process in the industry. And you deserve a new way to think about strategic partnership. Today is just the beginning.

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