Accelerate to proof of concept and transition to Phase II

Phase 1 to Phase 2.

CDMO track record and expertise

Engaging with the right CDMO to support your pathway.

Managing the technical and regulatory challenges of moving from Phase 1 to Phase 2 clinical trials can be complex, requiring the coordination of numerous intricate processes, such as formulation development, process optimization, scale-up, and GMP manufacturing.

Our expertise in the development of oral, nasal and pulmonary dosage forms, alongside an Executive Leadership Team member on each project, ensures you’re in good hands. Explore CDMO partnerships for clinical trial success.

Confidence transitioning from Phase I to Phase II

Technology transfer and scale-up.

Our team of experts ensure a seamless transition between phases, including process optimisation, technical transfer, increased batch sizes and QC validation.

A science-led and collaborative approach across all layers of our business ensures your clinical trial materials meet the highest standards for safety and quality.

Supporting IND applications

Regulatory strategy and support.

Experience in solubility, stability and safety. By partnering with an experienced CDMO, you increase the likelihood of your product being successful in each development stage.

Regulatory support

Formulation
Development

Our team has extensive experience in selecting the correct oral, nasal and pulmonary dosage forms to ensure success in getting to the clinic.

Formulation and analytical development
Toxicology supplies
ASAP stability to support clinical prototype selection

Phase 1 - Phase 2 Clinical Supply

We can help you accelerate to Phase 1 clinical trials through formulation optimisation and identify the next steps to transition into Phase 2 clinical trials following Phase 1 data.

Clinical manufacturing and QC testing
Qualified Person Release
Clinical stability

Process Scale-Up for Phase 3

We understand the complexities of scale up and technical transfer. Covering all aspects from equipment consideration through to manufacturing handover and QC.

Process optimisation robustness (Qbd, DoE)
Method validation
Cleaning validation

Frequently Asked Questions

Here are some frequently asked questions about late phase

How do you optimise your CDMO services to meet Phase 2 clinical trials requirements?

At Upperton, we understand that Phase 2 trials are crucial for validating the therapeutic potential identified in Phase 1. Our specialised services are designed to manage the increased complexity and stakes of this phase. We offer:

Refined Formulation Development: Leveraging Phase 1 data, we optimize formulations to enhance efficacy, minimize side effects, and improve patient adherence.
Scalable Manufacturing Solutions: As you transition to mid-scale manufacturing, we ensure consistent quality while maintaining the flexibility to adapt based on trial results.
Expert Regulatory Guidance: We provide tailored support to navigate the specific regulatory requirements of Phase 2, ensuring compliance and thorough documentation.

Can Upperton provide regulatory support during Phase 2?

Yes, our regulatory affairs support service includes expert guidance, detailed documentation support regarding regulatory submissions, IND amendments and briefing packages.