Select Language:
Home » Facilities

Facilities

Corealis Pharma facility indoors

Corealis operates one of the most advanced and comprehensively equipped pharma formulation labs as well as clinical supplies manufacturing and packaging facilities

Corealis’ highly sophisticated formulation, analytical and manufacturing laboratories are distinctly designed to maintain agility in the execution of clients’ projects and can modify and pivot directions quickly to appropriately accommodate. The unique variations of proposed solutions accelerates timelines and cements us as a top CDMO partner.

With 2 all-encompassing, state-of-the-art, modern facilities located in the pharma-biotech campus in Montreal, Canada, coordination is now more efficient and accurate than ever.

The Corealis buildings

Corealis boasts 2 best-in-class facilities spanning over 60,000 sq ft.

With over 20,000 sq. ft., our initial site is a 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.

Our reputable secondary facility expands over 30,000 sq. ft., and 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.

Facilities

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, including highly potent API’s, 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 Expertise work

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 preclinical pharmacokinetics.

 

Book a visit
Corealis Lab

Contact Corealis

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

Contact Corealis