Un-savoir-faire-reconnu

A recognised

expertise

AdhexPharma supports pharmaceutical and biotechnological companies as well as the academic and scientific community in their projects of development and manufacturing of drugs in transdermal, topical, oral and transmucosal form.
100% focused on the satisfaction of its customers' needs, AdhexPharma is your dedicated partner at each step of the CMC development of your product

CMC Development

(Chemistry Manufacturing Control)

1.

Formulation

  • Evaluation of the physico-chemical characteristics of the API
  • Study of the compatibility of the active ingredient with polymers
  • Formulation and analytical development
  • Pre-stability studies
  • In vitro and ex vivo proof of concept
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2.

Development

  • Production of the technical batches for the transfer to industrial machines
  • Production and release of clinical batches
  • Feasibility studies according to the ICH Q10 standard
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3.

Registration and validation

  • Production of registration and validation batches
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4.

Regulatory expertise

  • Pre-clinical evaluation of safety and efficacy
  • CMC writing
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Pilot

area

AdhexPharma has invested in a pilot area with all the dedicated equipment (mixers, coating tunnels, converting and packaging machines) required to manufacture patches and orodispersible films in a GMP environment (batch size from 0.1 to 25 kg).

This pilot equipment is a replica of the industrial tool and allows for an efficient transfer to the industrial stage, reducing any impact and uncertainty associated with the batch size increase.
This equipment is qualified to produce technical and clinical batches for our three forms of drug delivery:

  • Transdermal and topical patches
  • Orodispersible films
  • Impregnated matrices

In parallel to this equipment, a dedicated team of engineers can support our customers in their development for any specific machine or process needs for their product or project.

Zone-de-pilotage