Phase I-II

Icon for discovery phase of new drug development

Developing and implementing a clinical-scale process can be time-consuming and complex, requiring specification, sourcing and integration of many components. With a clinical scale template, you can rapidly establish your own capabilities for production of your pre-clinical, Phase I, and Phase II material. Developing and implementing a clinical-scale process can be time-consuming and complex, requiring specification, sourcing and integration of many components. With a clinical scale template, you can rapidly establish your own capabilities for production of your pre-clinical, Phase I, and Phase II material.

You can also learn more about typical processes with these biopharm application guides for:

  • Plasma
  • Vaccine and viral therapy
  • Monoclonal antibodies (mAbs)
  • Antibody drug conjugates (ADCs)
  • Microbial


Infographic of Phase I-II biomolecule evaluation stages, including timelines and process requirements

The right resources allow you to focus on discovering innovations that may help patients in need. Select any stage of process 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

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