Switching to DENARASE^®: Regulatory considerations for Biopharmaceutical Manufacturing

c-LEcta GmbH, a leading biotechnology company, has released a new guidance document to support the change to DENARASE^® in approved biopharmaceutical manufacturing processes. The guidance is based on an assessment by our quality and regulatory departments, supported by external consultants and feedback from customers that already implemented such a change. By outlining several essential steps for managing changes to DENARASE^®, c-LEcta reaffirms dedication to supporting the biopharmaceutical industry.

Understanding the Change Management Process

The document, titled 'Guidance on Change to DENARASE^® in Approved Biopharmaceutical Manufacturing Processes', outlines the considerations for transitioning from endonucleases from other vendors to DENARASE^®. It summarizes different aspects to be considered during a change to DENARASE^®, which helps to define the scope of comparative studies, application tests, and validations required. For more information or any inquiries, please don't hesitate to reach out!

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