Phase III and Manufacturing
Whether manufacturing clinical trial batches for Phase III studies or producing drug product for commercialization, your process must continue to meet quality high standards. Among the factors to consider at this stage are:
- Ensuring regulatory compliance
- Determining if and how the process can be further optimized for large scale production
- Deciding whether manufacturing be in-house or outsourced to a CMO
Today's single-use technologies can add flexibility to your facility. Learn how to minimize 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
- Make it Right: Best Practices for mRNA Manufacturing
Discover the potential of mRNA and how its manufacturing workflows and facility design impact reproducibility and performance in this insightful webinar.
- Integrated Approach to Support ADC Programs from Concept to Clinical Material
Explore the challenges and promises of ADC production and learn how raw material characterization and an integrated approach can streamline manufacturing.
- Going Viral: Process and Facility Design Considerations for CGT Manufacturing
Learn about the unique challenges and strategies in viral vector therapy manufacturing for CGTs. Learn how facility design impacts reproducibility and performance.
- Driving the Viral Vector Expressway: Speeding Through AAV Manufacturing
over how the templated viral vector process accelerates AAV manufacturing, enhancing efficiency through high-throughput screening and improved transfection.
- Guidebook: A Molecule’s Journey: Breaking Down Roadblocks to Clinical Success
A guidebook for biopharma executives navigating the complexities of clinical development. Learn how to successfully bring a molecule from the lab to the clinic.
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 I–II
Accelerating your process development with tips, templates, and application guides
Phase III and Manufacturing
Progressing from scale-up and tech transfer to quality production for trials and commercialization
Regulatory
Navigating one of the world’s most regulated industries starts with a trusted guide
Startup Programs
Connecting with resources and grant programs that can unlock your molecule’s potential
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.
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