GMP Manufacturing - Clinical Trial Materials
The cGMP manufacturing facility at Frontage was designed to produce solid oral dosage forms, as well as semi-solid, liquid and aseptically filled liquid and powder sterile products containing either non-potent or potent compounds. Batch sizes may range from a few units up to 120 kg for solid dose, 350 kg for semi-solids and liquids and up to 100 liters for aseptic processes. Packaging may be supplied in bottles, vials and ophthalmic droppers, with other solutions available from local packaging vendors. Our process facilities have been specifically designed for quick turnaround and reduced costs. Wherever possible, disposable equipment is used in order to reduce cleaning verification costs and improve environmental controls.
Each of our skilled scientific staff members have significant industry experience and training from the bench to the marketplace. This, combined with our team’s commitment to the success of your project, dramatically simplifies the implementation and scale-up of any process.
Equipment
Granulators
High shear (1 liter, 3 liter, 5 liter and 5 gallon capacity)
Fluid bed (granulator/dryer/coater – 5 liter, 20 liter and 50 liter)
Hot melt with temperature controls from +/- 40°C to 200°C
Blenders
V blenders 1 qt., 2 qts., 4 qts., 0.5 cu. ft., 5 cu. ft. and 10 cu. ft.
Bin blender
Tablet Press
Kitkasui Tri-layer Tablet-in-Tablet press, 8 stations
Killian press with B type and D type interchangeable turrets
Encapsulators
Hand-fill encapsulators (100 fills/plate and 300 fills/plate)
Schaefer automatic encapsulator (2,000 capsules/hr)
Bosch encapsulator (50,000 capsules/hr) capable of handling powders, pellets, mini tablets and liquid in hard gelatin capsules
Conventional Pan Coater
12”, 16” and 24” inserts
Neat API in Capsules
Powder filling system for as low as 1 mg to a few grams
API filling in capsules for preclinical studies
Sterile API Fill
Lyophilized and dry powders for parental administration
Starting from 1 mg to a few grams
