Pharmaceutical development laboratory

Azpiegiturak
Ikerketa arloak
  • Life & Medical Sciences
Web gunea
https://www.tecnalia.com/en/infrastructure/pharmaceutical-development-laboratory
Kontaktua

946 430 850

(+34) 946 430 850 (International calls)

Kanpoko erabiltzaileentzako eskuragarri?
Yes
Deskribapena

This laboratory provides a comprehensive infrastructure for the pharmaceutical formulation (galenical) and analytical development of medicinal products, tailored to the requirements of the industrial pharmaceutical sector and certified by the Spanish Agency of Medicines and Medical Devices (AEMPS) in accordance with Good Manufacturing Practice (GMP) standards.

With more than 3,500 m² of laboratory space, the facility is designed to cover every stage of pharmaceutical product development, from excipient selection and formulation development to process design, scale-up, and stability studies in accordance with ICH guidelines.

The infrastructure is equipped to handle multiple pharmaceutical dosage forms, including solid, liquid, and semi-solid formulations. It provides comprehensive services to industry, research centres, Contract Research Organisations (CROs), and Contract Development and Manufacturing Organisations (CDMOs).

Additional capabilities include comprehensive analytical testing, quality assessment, dissolution studies, physicochemical characterisation, and packaging under simulated industrial conditions.
 

Equipment

  • Solid pharmaceutical forms:

    - Rotary and eccentric compression machine
    - V mixer
    - High speed mixer / granulator
    - Fluid bed
    - Coating pan
    - Capsule filler
    - Extruder/ spheroniser
    - Spray-dryer
    - Freeze-dryer
    - Voluminometer
    - Rotolab

  • Liquid and semi-solid pharmaceutical forms:

    - Paddle stirrer
    - Ultra-Turrax homogeniser
    - Colloid mill
    - Rheometer
    - Viscosimeter
    - Osmometer

  •  Control equipment:

    - Analytical balance and moisture analyser
    - Durometer
    - Friability tester
    - Disintegrator
    - Dissolution test equipment and fraction collector
    - Granulometric analysis equipment based on laser diffraction and Coulter

  • Other equipment:

    - Biosafety cabinet
    - Differential scanning calorimetry (DSC)
    - Primary packaging equipment (blister packaging machine)

Zerbitzuak
  • Pharmaceutical formulation development for multiple dosage forms
  • Formulation adaptation to patient requirements and AEMPS regulations
  • Industrial scale-up and technology transfer to manufacturing facilities
  • Stability studies under ICH conditions
  • Physicochemical testing of active pharmaceutical ingredients (APIs) and finished products
  • Simulated primary packaging and process validation
  • Support for companies without in-house laboratories for development and validation activities
  • CDMO services for preclinical and clinical development stages
  • Technical and analytical support for manufacturers of medicinal products and APIs
  • Regulatory support and technical documentation for marketing authorisation applications

Aimed at:

  • Pharmaceutical laboratories
Kokapena

TECNALIA

Alava Science and Technology Park, Leonardo Da Vinci, 11, E-01510, Vitoria-Gasteiz (Araba/Álava)

10/5000 Beste informazio batzuk
Pharmaceutical Development and Manufacturing (GxP):
- Biotechnology, Biological Processes and Systems
- Healthcare Technologies

Application sectors

  • Functional food and nutraceuticals
  • Contract Development and Manufacturing Organisations (CDMOs) and Contract Research Organisations (CROs)
  • Clinical and research centres requiring pharmaceutical formulation development
  • Biotechnology companies
  • Regulated cosmetics companies
  • Generic drug development companies
  • Pharmaceutical and genetics sector
  • Human and veterinary pharmaceutical industry
  • Biopharmaceutical start-ups

Industrial plan

  • HAZI · Healthcare and Biosanitary Sector