Phase III and Manufacturing

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.



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.

Illustrated flowchart of flexible scale-up from pre-clinical phase to full manufacturing, using Mobius® bioreactor platform

Biotech Hub Resources Workflow

Biotech Resource Hub

Biotech Resource Hub

Starting your journey to successful drug discovery, development, and commercialization

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