GMP Manufacturing
From Development to Clinical Manufacturing with Confidence
GMP clinical manufacturing is where development is translated into a reproducible, high-quality drug product. At Corealis, we produce oral solid drug products using processes that are designed during formulation development and optimized for clinical supply.
Our integrated environment ensures continuity between development and manufacturing, minimizing risk and enabling efficient progression into clinical trials. Whether producing small early-phase batches or preparing for more advanced studies, we deliver reliable, high-quality clinical materials.
Our GMP Manufacturing Workflow
Process Transfer & Preparation
Formulation and process knowledge is transferred into GMP manufacturing with defined batch records and documentation.
Process Optimization & Scale-Up
Manufacturing processes are refined to ensure consistency, robustness, and scalability.
GMP Batch Manufacturing
Clinical batches are produced under GMP conditions using validated equipment and controlled environments. Environmental controls maintain 20°C ± 3°C and 40% RH ± 5%, supporting low-humidity API/formulation requirements.
Release & Documentation
Finished products undergo analytical testing, quality review, and release to support clinical trial use.
Typical Timeline
From Molecule to Clinical Supply
A structured development pathway designed to accelerate oral solid dose programs from early formulation to GMP clinical manufacturing. While timelines vary depending on API complexity and formulation strategy, a typical development pathway may include:
Pre-Formulation & Method Evaluation:
1-2 weeks
Prototype Development 5-8 Prototypes:
4-5 weeks
Engineering Batch:
2-3 weeks
GMP Batch Preparation & Planning:
2 weeks
GMP Manufacturing, Release and QA Review:
6 weeks
Report:
4-6 weeks
Typical duration:
4–6 months or less.
*Timelines may vary depending on program complexity and development strategy.
Key Manufacturing Equipment
Corealis is equipped with advanced manufacturing technologies to support a wide range of oral solid dosage processes.
Representative equipment includes:
V-blenders and bin blenders (1–300 L range)
Wet and dry granulators (multiple scale ranges)
Fluid bed dryers, coaters, and granulators
Milling systems (Comill up to 100 kg/h)
Tablet presses (multiple station configurations)
Encapsulation machines (up to ~40,000 units/hour)
Coating pans (various sizes)
Extrusion and spheronization systems
Solid dispersion equipment and spray drying systems
Spray drying (500g/day, 5KG/batch)
These systems enable flexible manufacturing for early-phase clinical programs and beyond.
See Our Development Facilities
Corealis operates more than 60,000 square feet of integrated formulation, analytical, and GMP manufacturing facilities located in Laval, Canada.
Visiting our laboratories provides an opportunity to meet the scientists supporting your program and see firsthand how our teams collaborate to solve complex formulation challenges.
FAQ
What phases of manufacturing does Corealis support?
What types of drug products do you manufacture?
Can Corealis handle high-potency compounds?
How do you ensure manufacturing scalability?
How long does GMP manufacturing take?
Do you provide release testing and documentation?
Learn more how Corealis can support your drug product development needs.
