Phase I/II Clinical Supply.

Reliable Phase I/II clinical supply services from Upperton, delivering GMP manufacturing, packaging, labelling and distribution to support early-stage clinical trials efficiently and compliantly.

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Phase I/II Development Stage

Engage 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.

Phase I/II Development Stage

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.

Speak to us about how we can support you with phase I/II clinical supply

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partnership

An end-to-end Partner for drug development

We provide fully integrated services across every stage of drug product development:

Microscope and analysis equipment at the Upperton facility

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.

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

Upperton scientist examining a formulation flask

Phase I-II 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.

o Clinical manufacturing and QC testing
o Qualified Person Release
o Clinical stability

Test tubes used in complex molecule formulation development

Process Scale-Up for Phase III

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

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

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.

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

Phase 1/2 clinical supply covers the manufacture, packaging, labelling and release of investigational medicinal products (IMPs) used in early‑stage clinical trials. These phases focus on first‑in‑human dosing, safety, tolerability, and early efficacy, often requiring flexible batch sizes, rapid timelines and close technical support.

Upperton supports a wide range of early‑phase dosage forms, including oral solid dose (OSD) formats such as capsules and tablets, as well as enabling formulation approaches designed to support first‑in‑human and proof‑of‑concept studies.

Yes. Upperton’s integrated development and manufacturing model is designed to accelerate early‑phase programmes. Close collaboration between formulation scientists, analytical teams and manufacturing experts helps minimise handovers and streamline timelines from development through to clinical supply.

Upperton specialises in small‑scale, high‑value clinical batches. Manufacturing processes and facilities are designed to be flexible, ensuring material is produced efficiently without over‑manufacturing, while maintaining full GMP compliance.

Yes. Upperton offers clinical packaging and labelling suitable for Phase 1/2 studies, ensuring materials meet regulatory and study‑specific requirements, including randomisation, blinding and country‑specific labelling where needed.

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We provide fully integrated services across every stage of drug product development.

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