MilliporeSigma

Phase I-II

Biotech Resource Hub

Once the application for an investigational new drug (IND) is accepted, Phase I clinical trials can begin. During this development phase, the drug candidate will be tested on healthy individuals for safety.

Now is the time to develop, standardize, and scale drug manufacturing capabilities and ensure the proper analytics and quality control processes are in place capacity standardized

Once drug candidate safety is established, Phase II trials will evaluate efficacy. Success in this phase can lead to interest from partners and investors. In this stage, the focus is on scaling and further optimizing processes, and ensuring compliant endotoxin levels and sterility.

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  pre-clinical, Phase I, and Phase II material.

 Learn more about templated processes with these biopharm application guides for:

  • Vaccines (including mRNA)
  • Monoclonal antibodies (mAbs)
  • Antibody drug conjugates (ADCs)
  • Microbial
  • Plasmid DNA (pDNA)
  • Cell and Gene Therapy (CGT)

Biotech Resources

Page 1 of 2

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

Access to the right resources helps you focus on discoveries and clinical candidates with the greatest potential to  help patients in need. Select your stage of the development process to learn more or follow the product and service links for 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



Sign In To Continue

To continue reading please sign in or create an account.

Don't Have An Account?