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Facilities

Corealis has one of the best-equipped pharma formulation labs, clinical supplies manufacturing and packaging facilities in the world.

Corealis’ formulation, analytical and manufacturing laboratories are designed in such a way as to remain agile in the execution of clients’ projects. A change or re-direction will take days rather than weeks or months.

The company’s facilities span two adjacent buildings located in a pharma-biotech research campus in Laval, a suburb of Montreal.

The Corealis buildings

The first building is a 15,000 sq. ft. facility dedicated to clinical supplies cGMP manufacturing, packaging, labeling, and clinical supplies management (patient kit preparation, warehousing, distribution, and reconciliation). The facility meets the ICH regulatory requirements for pharmaceutical oral solid dosage cGMP manufacturing.

The second, 30,000 sq. ft., facility houses the laboratory for pre-formulation and formulation development, analytical method development, R&D testing, GMP release and stability testing. The facility also houses the stability chambers.

The Corealis site hosts an array of specialized equipment for pre-formulation and analytical work including:

  • Ultra-performance liquid chromatography (UPLC)
  • Headspace gas chromatography (GC)
  • Dissolution equipment
  • X-ray powder diffraction (XRPD)
  • Differential scanning calorimetry (DSC)
  • Thermogravimetric analysis (TGA)
  • Scanning electron microscopy (SEM)
  • Particle sizers using microscopy and laser diffraction
  • Parallel artificial membrane permeability assay (PAMPA)
  • R&D and GMP stability chambers set at various ICH conditions.

These facilities enable comprehensive chemical and physical characterization of APIs, prototype formulation of intermediate drug products, and finished product analysis.

GMP manufacturing

Located in the first building, the GMP manufacturing area is divided into production modules where each module has its own heating/ air conditioning and humidity control unit (HVAC) that operates on a single pass airflow system with HEPA filtration.

This minimizes the possibility of cross-contamination when working on several compounds simultaneously. The United States Pharmacopeia (USP) standard water and compressed air systems service all of the GMP manufacturing areas.

Most of the GMP manufacturing equipment is mobile, and depending on the manufacturing process train and batch size, appropriate equipment is brought into a module for clinical supply manufacturing, packaging and labeling.

The facility offers the required space to meet the diverse needs of projects and ensures Corealis has adequate storage for clinical supply management.

Corealis’ expertise

Corealis scientists are process experts in powders, tablets, granules, and multi-particulates for Immediate and Modified Release formulations for one or several APIs applicable for different patient populations:

  • Tableting
  • Encapsulation
  • Dry granulation (RC)
  • Wet granulation (FB, high and low shear)
  • Amorphous enabling technologies (spray-drying (aqueous/solvents), coprecipitate dispersion, solid dispersion and melt extrusion)
  • Extrusion and spheronization
  • Coating (FB and pan)

Corealis’ labs

The laboratories and manufacturing facilities are temperature and humidity controlled to enable effective formulation development. This allows the team to manufacture small-scale prototype formulations for in vitro testing and size-appropriate animal PK testing (animal PK testing not performed by Corealis).

The Corealis quality, administrative, sales and marketing teams are also based on site.

Contact Corealis

Corealis’ experts are ready to answer any queries about the company’s oral solid dose offering, including its development and manufacturing capabilities.