Discuss a project

High Potency APIs (HPAPIs)

Supporting highly potent compounds up to OEB 5 through integrated formulation development, analytical testing and GMP manufacturing.
Discuss a project

HPAPI Development

Drug Product Development Expertise for Highly Potent APIs up to OEB5.

As the pharmaceutical industry increasingly focuses on targeted therapies, many drug products contain highly potent active pharmaceutical ingredients (HPAPIs) that require specialist handling and containment throughout development and manufacturing.

At Upperton, we support the development and manufacture of drug products containing highly potent compounds, with capabilities designed to handle materials up to OEB 5.

Our facilities, equipment and operating procedures are engineered to enable the safe handling of potent materials while maintaining product quality and protecting personnel.

Whether incorporated into oral solid dose, nasal, pulmonary or other drug product formats, highly potent compounds can present unique formulation and manufacturing challenges. Our experienced scientists work closely with clients to develop robust formulations and manufacturing processes that support progression from early development through to clinical supply.

Sterile-finish isolator image with scientist working on biotech project.

Development Challenges

Containment Designed for Highly Potent Drug Development.

Upperton's containment infrastructure enables the handling of compounds up to Occupational Exposure Band (OEB) 5, supporting development programmes involving some of the industry's most potent molecules.

This capability allows clients to work with confidence, knowing their products are being developed and manufactured within a controlled environment designed to meet the demands of potent compound handling.

As an integrated CDMO, we provide:

  • Formulation development for drug products containing highly potent APIs
  • Analytical development and testing
  • Clinical trial supply manufacturing
  • Technology transfer support
  • Specialist containment capabilities up to OEB 5
  • Expertise across a range of dosage forms, including oral, nasal and pulmonary products

By combining specialist containment capabilities with deep formulation expertise, Upperton helps pharmaceutical and biotechnology companies advance highly potent drug products safely and efficiently.

Sterile-finish isolator image with scientist working on biotech project.

up to oeb5

Containment Infrastructure Designed for Highly Potent Compounds.

Successful HPAPI development requires more than scientific expertise. It requires facilities specifically designed to manage potent compounds safely and efficiently.

Upperton supports programmes involving highly potent materials through containment capabilities up to OEB 5, enabling the safe handling of compounds requiring stringent exposure controls.

Our facilities, engineering controls and operating procedures are designed to:

  • Protect personnel
  • Maintain product quality
  • Minimise cross-contamination risks
  • Support GMP manufacturing
  • Enable robust process development


This allows clients to progress demanding development programmes with confidence.

partnership

Why choose Upperton as your
high potency CDMO partner.

A Specialist CDMO for Complex and Highly Potent Drug Products

Microscope and analysis equipment at the Upperton facility

Specialist Formulation Expertise

Integrated, end-to-end capabilities delivered under one roof.

Upperton scientist examining a formulation flask

Integrated Development and Manufacturing

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

Test tubes used in complex molecule formulation development

Advanced Containment Capability

Containment infrastructure designed to safely support drug products containing compounds up to OEB 5.

Upperton senior leadership overseeing laboratory work

Executive Leadership on Every Project:

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

Discuss your high potency programme with our experts.

Contact Us

Download Information Sheet

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

This field is for validation purposes and should be left unchanged.

Common Questions About HPAPI Development

A highly potent active pharmaceutical ingredient is a compound capable of producing a biological effect at very low concentrations and therefore requires specialist handling and containment during development and manufacturing.

Yes. Upperton provides formulation development, analytical development and GMP clinical manufacturing services for drug products containing highly potent compounds.

Upperton supports programmes involving compounds requiring containment up to OEB 5.

Yes. We provide GMP clinical manufacturing and clinical supply services for a wide range of drug product formats.