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Early Stage Program

Early Stage Development

Formulation development

We have extensive experience in solving complex formulation challenges. Our experts will advise you on the best solution to optimise drug delivery for the benefit to the patients. We could include our range of proprietary technologies to provide modified, pulse or timed release profiles  to solve technological challenges, to provide patient benefits and to offer additional proprietary protection to the product.

Prototyping

We perform rapid and flexible prototyping essays to early characterized powders leading to anticipate potential up scaling issues which lead to save time and money.

Our key differentiators regards our compression simulator (Styl’One Evolution) and low scale equipment which reproduce industrial processes such as wet granulation, compression including tabletting and roller compaction and coating.

 

Product manufacturing for clinical trial

Once formulation is validated, we use our cGMP facilities to supply product for clinical study. Regulatory support is provided to assist you during clinical phases.

  • Small API needed for small scale production
  • High quality prototyping with rapid screening of formulation options.
  • Rapid study of parameter impact on product specifications
  • Rapid Technology transfer
  • Process validation – Design of Experiment support (QbD)
  • Process robustness
  • Delivery of cGMP and non-cGMP protoypes
  • Wet granulation : ProCeot HSM 1 & 4L
  • Drying : ProCept FBD 1 & 4L
  • Milling : Erweka AR 403 + FGS
  • Lubrification/Blending : Erweka AR 403 + Cube
  • Tableting : Styl’One Evolution (with multi-layer and press-coating modules)
  • Film coating : ProCept Pan Coater
  • Packaging : PMC bottle line / Rohrer blisterline