Focusing on small-molecule oral solid drugs, our Pamplona site specializes in highly potent compounds and differentiating technologies
Focusing on small-molecule oral solid drugs, our Pamplona site specializes in highly potent compounds and differentiating technologies including spray drying, from development to clinical manufacturing for early and late phases, as well as commercial manufacturing of niche drugs.
We guide our customers into making smarter formulation choices. This reduces the risk of clinical failure and ensures your product reaches the clinic rapidly via the most efficient route.
Solving a problem and saving time, overcoming your development challenges is our specialty. We work with you to understand your product needs and develop the best possible formulation.
From our facilities to our people, we are engineered to be top performers. We deliver consistent non-GMP and GMP drug product manufacturing services to the highest standards and to your timescales.
We can handle a variety of dosage forms including highly potent compounds and controlled substances with a specialism in small-scale batches
Amorphous solid dispersions increase solubility by eliminating the impact of crystal lattice energy on the dissolution process.
The physical stabilization of the amorphous state of the drug substance is accomplished via dispersion in a polymer matrix. We identify polymers with sufficient solid-state miscibility with the drug substance to prevent recrystallization and ensure consistent performance over time via a combined approach of precipitation assays and solvent evaporation trials, both conducted at a milligram scale.
Formulation concepts with adequate performance and physical stability are subsequently scaled-up and GMP-produced via spray drying or bead coating.
We provide a comprehensive solution to your solubility, stability and bioavailability problems by combining experience and capabilities in formulation, analytical and process development and technologies including spray drying. We also have suites capable of handling highly potent active substances.
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.
Get in touch to see how we can craft your path to the clinic with dedicated capabilities.
Esta empresa ha recibido dos subvenciones del Gobierno de Navarra al amparo de la convocatoria de 2020 de ayudas para mejora de la competitividad (expedientes 0011-1463-2020-000045 y 0011-1463-2020-000115)
Esta empresa ha recibido una ayuda cofinanciada al 50% por el Fondo Europeo de Desarrollo Regional a través del Programa Operativo FEDER 2014-2020 de Navarra
Esta empresa ha recibido una subvención del Gobierno de Navarra al amparo de la convocatoria de 2021 de ayudas para mejora de la competitividad (expediente 0011-1463-2021-000052)
Esta empresa ha recibido una subvención del Gobierno de Navarra al amparo de la convocatoria de 2022 de ayudas para mejora de la competitividad (expediente 0011-1463-2022-000080)