New Product Introduction Department

New Product Introduction Department

NPI

Our New Product Introduction department brings a valuable expertise to our clients from early stage development phase to scale up and full commercial manufacturing.

Skyepharma’s dynamic project managers are highly experienced in the coordination of development resources and activities by directly supervising the pilot unit and ensuring optimal performance. As part of an integrated team with our partners and suppliers, our project managers’ transversal competencies allow them to lead complex oral product development programs, from small scale feasibility studies to full scale development of oral formulations.

By always caring and listening to our clients’ needs, we provide a single point of contact to our partners to ensure rapid and efficient communication. We make sure that projects are delivered on time and within budget in full transparency with our partners.

Partnering with Skyepharma will deliver value across all stages of your development or technical transfer program. We are committed to providing process optimisation and smart solutions to secure project success.

As a Solution Provider

Delivering technical expertise is as important as providing the right management skills.

 

PILOT UNIT

We are committed to delivering efficient technical and analytical procedures. To do so, our pilot unit experts are motivated, dedicated, reliable and highly skilled talents used to work in high technological environment.

Through all the product development stages, our team remains under the direct supervision of the project management team. The pilot plant activities are driven by our experts, with seamless transfer to production.

Our pilot plant ensures the delivery of cGMP and non cGMP prototypes. We offer process development and optimisation, scale-up, trouble shooting, all being supported by a Quality by Design approach.

TECHNICAL CAPABILITIES

Our pilot plant benefits from a modern equipment :

  • Totally independent from the production area
  • Capable to deliver cGMP & non-cGMP prototypes
  • All process equipment for oral technologies available at 1/10th of industrial scale, including an industrial tablet press: Sviac for triple layer tablets
Wet granulation
Drying
Milling
Lubrication – Blending
Tabletting
Film coating

PILOT PLANT :
Aeromatic Fiedler PMA 25/65

DEVELOPMENT :
ProCept HSM 1 & 4L

PILOT PLANT :
Aeromatic T/SG2 B5-F4

DEVELOPMENT :
ProCept FBD 1 & 4L

PILOT PLANT :
Quadro Comil 197S
Frewitt MG 205

DEVELOPMENT :
Erwaka AR 402 + FGS

PILOT PLANT :
Bohle Bin blender

DEVELOPMENT :
Erweka AR 402 + cube

PILOT PLANT :
SVIAC PR51 CM3

DEVELOPMENT :
Styl’One Evolution (with multilayer and press coating modules)

PILOT PLANT :
Glatt GC 500/750

DEVELOPMENT :
ProCept Pan Coater

The industrial revolution
STYL'ONE EVOLUTION

The STYL’One Evolution is our revolutionary development equipment : fully instrumented, the STYL’One Evolution is a real R&D “tableting robot” which allows us to explore the design space, to deeply analyze formulations and process with utmost efficiency. 

This tablet press simulator performance allows us to generate highly relevant data using very reduced quantities of API or blends:

  • Simulation and prediction of the tableting performance of formulations on high speed tablet presses
  • Simulation and analysis of production of all the major industrial presses
  • Simulation and analysis of non-conventional production presses like multi-layer tablet presses or press-coaters
Styl'One Evolution

TECHNICAL CHARACTERISTICS

  • Last generation Compression simulator
  • Uses production tooling
  • Tablet production from manual feeding up to 1200 per hour
  • High sensitivity and reactivity piezzo electric force sensors
  • Force feeders and take off sensor
  • Characterize and simulate standard tabletting
  • Characterize and simulate multilayer tabletting with control of layer tamping and final pressures
  • Characterize and simulate tab in tab technology
  • Study of powder compression characteristics
  • Simulation of industrial presses at commercial speeds
  • cGMP production module (21CFR part 11 compliant)

Mastering the Styl’One Evolution increases the development speed in an exclusive and continuous approach: Contact us to find out more about our integrated services.