High potency and controlled substances

High potency and controlled substances

Specifically engineered to meet your needs from pre-clinical to small-scale commercial manufacturing, we have specialist facilities and expertise for handling highly potent compounds and controlled substances.

Uniquely engineered to support process development and GMP manufacturing

We have dedicated suites in our drug product formulation and analytical development laboratories designed for the handling of HPAPIs and a specialized GMP manufacturing plant built as a high containment area.

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Highly potent substances and products

Highly potent substances and products

Our laboratories feature 100% air renewal and the necessary personal protective equipment and other measures in place to guarantee the safety of our operators and the secure handling of your potent products.

We deliver GMP manufacturing of highly potent drugs in a dedicated facility with clean rooms that meet EU-GMP class C standards (ISO 7, US FED STD 209E class 10000 equivalent).

At the start of each development or manufacturing project, we carry out a thorough risk analysis of your active substance, ranking its operational exposure level (OEL) or band. We take into consideration the characteristics of our facilities and equipment, as well as the necessary personal protective equipment and the properties of the active substance to determine that we can safely handle your materials.

In most circumstances, we can work with substances in categories 1 to 4 (up to OEL of 0.1 µg/m3), which comprise the overwhelming majority of HPAPIs and products.

Controlled substances

We have the facilities, processes and expertise to develop and manufacture drug products with controlled substances for medical use that fall in the Schedule 2 through 5 categories, meeting all regulatory storage, testing and handling requirements.

Schedule 2

Drugs with a high potential for abuse, with use potentially leading to severe psychological or physical dependence.

Schedule 3

Drugs with a moderate to low potential for physical and psychological dependence.

Schedule 4

Drugs with a low potential for abuse and low risk of dependence.

Schedule 5

Drugs with lower potential for abuse and include preparations containing limited quantities of certain narcotics.

Related Resouces

Our expert team members share deep, scientific understanding and insights into manufacturing highly potent and controlled substances.

See all resources
Understanding Highly Potent APIs and Safe Handling in Drug Development at Ardena
Expert Q&A

Understanding Highly Potent APIs and Safe Handling in Drug Development at Ardena

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# Drug Substance High potency & controlled substances
On-demand webinar: Navigating highly potent drugs to clinic: best practices from API to drug product
Webinars

On-demand webinar: Navigating highly potent drugs to clinic: best practices from API to drug product

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# High potency & controlled substances

Your molecule, your journey, our mission.

Get in touch to see how we can craft your path to the clinic with dedicated capabilities.

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Our integrated platforms

Program management

Using the right standards at the right development phase, our comprehensive program management services streamline your small molecule drug development.

Drug substance

Helping you turn your compounds that show promise into GMP-grade drug substances.

Drug product

We advance your clinical candidates through the pipeline quickly and safely with specialist drug product services.

Bioanalysis

Our bioanalytical platform supports your preclinical and clinical stages with expert testing services.

CMC regulatory services

Our comprehensive CMC regulatory services streamline preparation and submission of your registration file.

Program management

Using the right standards at the right development phase, our comprehensive program management services streamline your large molecule drug development.

Drug product

We advance your large molecule candidates through the pipeline quickly and safely with specialist drug product services.

Bioanalysis

Our bioanalytical platform supports your large molecule drugs through preclinical and clinical stages with expert testing services.

CMC regulatory services

Our comprehensive CMC regulatory services streamline the preparation and submission of the regulatory files for your large molecule drug.

Program management

Using the right standards at the right development phase, our comprehensive program management services streamline your nanomedicine drug development.

Drug product

We turn your nanomedicine candidates into suitable drugs with specialist development and manufacturing services.

Bioanalysis

Our bioanalytical platform supports your preclinical and clinical stages with expert testing services.

CMC regulatory services

Our comprehensive CMC regulatory services streamline the preparation and submission of the regulatory files for your nanomedicines.