Smooth Transition and Qualification: How c-LEcta supports the Implementation of DENARASE in Biopharmaceutical Manufacturing Processes

Switching to another endonuclease in biopharmaceutical manufacturing is a decision that requires careful planning, regulatory alignment, and technical assurance. At c-LEcta, we understand the complexity of these processes and are committed to support our partners every step of the way. Whether you're transitioning from an alternative endonuclease or qualifying DENARASE^® for the first time, we provide comprehensive guidance to ensure a seamless integration. 

Supporting the Change to DENARASE^® 
Replacing an endonuclease with DENARASE^® in an established, already approved manufacturing process represents a process change that requires consideration of different aspects.

To support the transition to DENARASE^® , we provide: 

• Comprehensive product documentation

• In-depth knowledge about DENARASE^® 

• Available studies, helping to streamline decision-making

• Combined benefits of high product quality and dedicated customer support

For more detailed information how to change to DENARASE^® in approved Biopharmaceutical Manufacturing Processes request the Guidance:

Supporting DENARASE^® Qualification 
Introducing a new enzyme like DENARASE^® into a GMP-compliant process requires consideration of key aspects from regulatory standards. To support this, c-LEcta provides: 

• Comprehensive qualification guidance tailored to biopharmaceutical manufacturing 

• Dedicated regulatory support for US-market approvals via own Drug Master File  

• High product quality and reliable vendor support-streamlining the qualification process precisely when it becomes relevant 

Ready to integrate DENARASE^® into your biopharma process? Get guidance on the qualification and request your copy here: 

Ready to make the switch or start your qualification process? Contact our team or request the guidance documents to get started.