OTCQB: IGXT | TSX-V: IGX

Development Services

IntelGenx has more than 14 years of experience in development services across the full product lifecycle of drug development. We offer a broad spectrum of analytical and testing services in a GMP-compliant setting including raw materials testing, drug product release analytical testing, stability studies, formulation prototype development and clinical monitoring. We serve partners in several jurisdictions worldwide.


Development services

 

 

 

ANALYTICAL DEVELOPMENT AND TESTING

Analytical Methods

IntelGenx offer analytical method development services for compendial methods used for the development and manufacturing of the Product based on either of the following:

 

flag usa

THE UNITED STATES
PHARMACOPEIA (THE “USP”);

flag europe

THE EUROPEAN
PHARMACOPEIA (THE “EP”); OR

flag Japan

THE JAPANESE
PHARMACOPEIA (THE “JP”).

 

 

 


Development services

Raw Materials Testing (GMP)

IntelGenx offers full raw materials testing for our partners conducting clinical trial batch manufacturing, manufacturing registration batches and other activities in advance of commercial scale-up. Services include generating and verifying specifications, and full testing of raw materials.

 

IntelGenx performs a full array of analytical testing and stability studies for film drug product release, including for appearance, assays, impurities, dissolution, residual solvent or water content, uniformity, preservation amount and microbial activity.

 

Table 1: Pilot Batch Lots Placed on Stability

Conditions / Time points 0 1 wk 2 wk 3 wk 1 mo 2 mo 3 mo 6 mo
25°C / 60% RH 1           1 1
40°C / 75% RH             1 1

 

 


FORMULATION DEVELOPMENT (non-GMP)

IntelGenx provides early stage services for pre-GMP projects including formulation prototype, first prototype and production of pilot GCP batch of first prototype.

 

clinical monitoring
 

Clinical Monitoring

 

IntelGenx sponsors and monitors pilot clinical phase 1 studies to assess whether developped prototype formulations meet pharmacokinetic requirements for a pivotal clinical study. Along with conducting the pilot study, IntelGenx selects and monitors contract research organizations (CROs), drafts clinical study approval documentation including CTA and IND applications, provides on-site clinical monitoring, and makes clinical recommendations for advancing the development program.

 

 

analytical methods