HPAPI contained area

Discover our HPAPI cababilities

Welcome to 450 m² cGMP confined area for the development and production of strategic drugs based on highly active molecules, including immuno-oncological drugs.

The area is equipped for the simultaneous and controlled production of several therapeutic classes of drugs, including OEB 4/5 class.

As you can see on the video this area is perfectly suited for both production and development of Highly Potent API drug products. 

Eligible projects

OEB 4/5 molecules

Hazardous and Highly Hazardous API manipulated under extreme precaution conditions: isolators, split valves, cone valve drum containment, and continuous liners.

Oncology & immuno drug products

Oncology & immuno drugs production requires specific precautions to ensure both safety, efficacy and stable pharmacokinetic properties.

New chemical entities

Drug products with new formulations or new active pharmaceutical ingredients (APIs), created to achieve better treatment outcomes and reduce side effects.

Our capabilities

Tablets
millions de comprimés par an
0
Gélules
millions de gélules par an
0

Range of services

  • Development

    Skyepharma's expertise includes the preclinical stages of Highly Potent Product development, such as early-stage development.

  • Scale-up

    Scaling up the manufacturing of HPAPI substances is a critical and complex process that requires a multidisciplinary approach, integrating process engineering, safety protocols, regulatory expertise, and advanced equipment.

  • Clinical batches

    HPAPIs, due to their extreme potency at low doses, require highly specialized manufacturing processes, particularly during clinical trials. Safety, efficacy, and dosage are key factors. Skyepharma's expertise in clinical batch manufacturing ensures compliance with all regulatory and quality requirements.

  • Packaging

    Given the challenges associated with the highly potent substances, packaging solutions must provide reliable containment, prevent cross-contamination, and comply with strict regulatory guidelines. By adopting best practices, implementing robust safety measures, and selecting the right packaging materials, Skyepharma can ensure that HPAPIs are protected throughout their lifecycle—from production to patient administration.

Contact-us

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November, 2024

HPAPI area's official opening

inauguration