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:
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.
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
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.
Starting your journey to successful drug discovery, development, and commercialization
Identifying the considerations, resources, and support you need to develop a new biologics candidate
Establishing safety and effectiveness for your Investigational New Drug (IND) application
Progressing from scale-up and tech transfer to quality production for trials and commercialization
Connecting with resources and grant programs that can unlock your molecule’s potential
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