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Clinical Supply Manufacturing for Phase I/II Studies

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 a member on each project, ensures you’re in good hands. Explore CDMO partnerships for clinical trial success.

We support:

  • First-in-human studies
  • Phase I studies
  • Phase II studies
  • GMP manufacture
  • Packaging & labelling
  • Stability studies
  • QP release

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.

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GMP suites

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Blending capacity from 500g to 250kg

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Tabletting capacity from single tablet to 1,000,000 per day

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Blister packaging units per day, alongside bottles and sachets packaging

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Sq ft integrated R&D and MHRA approved GMP facility

Watch our webinar on scaling up from Phase I to Phase II

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Phase I/II Clinical Supply FAQs

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.

YOUR STRATEGIC CDMO PARTNER

Partner with Upperton

We provide fully integrated CDMO services across every stage of the drug product lifecycle.

One Site

Award-winning facility built for scale and continuity providing integrated, end-to-end capabilities delivered under one roof.

One Team

The same team from your early-stage development through to preparation for commercial readiness.

Dosage Form Expertise

Proven track record in solving formulation and delivery challenges across multiple dosage forms.

Executive Leadership on Every Project

Direct access to experienced senior leadership for strategic oversight and decision-making.