Phase III and Manufacturing
Whether manufacturing clinical trial batches or engaged in commercial production, your process must meet the same high standards as your R&D and clinical trials. Issues to consider in the manufacturing phase include:
- Regulatory compliance
- Engineering optimization
- Single-use manufacturing
- Your own 12,000 L to 20,000 L bioreactor, or outsourcing to a contract manufacturing organization (CMO)
Today's single-use technologies can add flexibility to your facility. Learn how to overcome transfer challenges and risks by implementing a strategy that utilizes single-use technologies. You can also learn more about technology transfer, as well as filter and single-use validation.
Biotech Resources
Webinar: Managing Process Scale-up and Tech Transfer
Webinar: Process of the Future: Cheaper, Faster, and Safer with Single-use Technologies
Article: Process and Facility Design for a Monoclonal Antibody Facility
Tool: Drug Discovery and Development App
Guidebook: A Molecule’s Journey: Breaking Down Roadblocks to Clinical Success
Facility Design
For operational flexibility, a single-use bioreactor platform can help you scale from small batch to full production capacity. There are many challenges in designing and constructing a single production facility so that it can produce different biosimilar monoclonal antibodies, from clinical studies through commercial production.
The right resources allow you to focus on discovering innovations that may help patients in need. Select any stage of development to learn more. Or follow the product and service links for supportive resources offering plug-and-play opportunities at the beginning of your startup creation.
Biotech Hub Resources Workflow
Discovery
Identifying the considerations, resources, and support you need to develop a new biologics candidate
Pre-clinical
Establishing safety and effectiveness for your Investigational New Drug (IND) application
Phase III and Manufacturing
Progressing from scale-up and tech transfer to quality production for trials and commercialization
Startup Programs
Connecting with resources and grant programs that can unlock your molecule’s potential
Regulatory
Navigating one of the world’s most regulated industries starts with a trusted guide
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