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Highly Potent & Oncology

One Source for Highly Potent & Oncological Products

The safe and reliable commercialization of highly potent medicines is crucial to meeting the needs of patients in oncology and other therapeutic indications.

As a global top-5 service provider in the production of highly potent APIs and drug products, we accompany you on your entire product lifecycle from early phase development and the manufacturing of clinical supplies, late stage registration and validation, to commercial manufacturing and packaging.

Whether it be complex syntheses, small molecules, peptides, linker-payloads for ADCs, tablets, capsules, or injectables, we can safely handle them all, with containment capabilities for OELs down to the picogram per cubic meter level.

Seamless Integration of Highly Potent APIs & Drug Products Across the Supply Chain


The Highly Potent & Oncology platform offers over 30 years of experience in the development and production of highly potent APIs and drug products.

Our extensive capabilities utilize state-of-the-art high containment technology, processes and services that elevate your project from clinical through commercialization.


Our Highly Potent API facilities focus on the development and manufacturing of HPAPIs from laboratory scale to commercialization for all potencies, including picogram level. This is possible due to a series of engineering controls and a well-defined, robust industrial hygiene program.

Your API development and manufacturing projects will benefit from our SafeBridge® accredited facilities and highly potent API services, which include highly potent small molecules and peptides (solution- and solid-phase) at all scales, as well as extensive purification expertise and highly potent chromatography.

Core HPAPI capabilities include:

  • Complex synthesis, small molecules & peptides
  • Products of all potency
  • API development
  • Clinical & commercial supply
  • Linker-payloads for drug conjugates
  • Highly potent chromatography (normal & reverse phase)
  • Highly potent lyophilization
  • Full analytical capabilities
  • Compliant with all major markets


Our sterile injectable cGMP facility has a long track record of experience in the production of highly potent sterile liquids in vials. The site offers technology transfer and manufacturing, and is comprised of two independent facilities: one for clinical supplies up to 10,000 units per batch, and the other facility with two commercial-scale filling lines, one which is fully dedicated to vials.

Core highly potent injectable capabilities include:

  • Aseptically-filled solutions in vials
  • Handling of highly potent small molecules, peptides & biological entities
  • Commercial-scale vial filling
  • Full analytical capabilities
  • Supply compliant with all major markets

Oral Solid Dose

Our Oral Solid Dose (OSD) drug product manufacturing facility provides a broad range of capabilities, specializing in the development and manufacturing of highly potent and oncology OSD forms. Our complete offering ranges from small scale as low as 100 g for formulation development of prototypes, to clinical scale (1-60 kg), up to 150 kg per batch for commercial scale. This continuum allows us to support every phase, from the initial formulation development to commercial scale manufacturing.

Core highly potent OSD capabilities include:

  • Coated & uncoated tablets, minitablets
  • Hard gelatin & HPMC capsules
  • Powders, granules, pellets
  • Conventional processing technologies including roller compaction, high shear & fluid bed granulation (aqueous & solvent processes)
  • Solutions for APIs with bioavailability challenges, including Hot Melt Extrusion (HME), spray drying, micronization, nanomilling & lipid-based systems
  • Immediate & modified release formulations
  • Pediatric formulations & taste masking
  • Labeling, packaging & distribution services
  • Full analytical capabilities
  • Supply compliant with all major markets

Your Benefits > Our Strengths

1) Proven Containment Technology > Highly Potent Manufacturing

Take advantage of our long manufacturing history of highly potent APIs and drug products with data-supporting containment practices.

2) Foster Entrepreneurial Spirit > Flexibility and Transparency

Benefit from our collaborative commitment to react with flexibility and transparency to your changing needs.

3) Organizational Integrity > Quality is at the Core of Everything We Do

Rely on our commitment to provide the highest quality and ensure product integrity for you and the patients you serve. Adherence to these principles is the responsibility of all employees at every level of the organization.

Seamless Integration Across the Supply Chain

Working and coordinating with several providers can be demanding and time-consuming when outsourcing a project. Our aim is to streamline your process, improve efficiency and reduce costs by consolidating multiple services in one organization. As your CDMO partner, we work alongside you to understand and anticipate your project needs.

We deliver them through seamlessly integrated technologies and services from across our expert global network that support the development and manufacture of pharmaceutical and biotech innovators’ complex modalities. Our bespoke end-to-end solutions span your supply chain, covering all stages from drug development to commercialization.

Find out more

Dr. Brittany L. Hayes

Director, Global Highly Potent & Oncology Platform