From prototype to full scale production
Solids/semi-solids, Aerosols, Sterile liquid/lyophilized injectables
Our manufacturing facilities are subdivided into four cGMP compliant plants. These plants are used to develop small scale prototype formulations or to produce clinical supplies at larger scales. We have the experience, the equipment and the regulatory perspective to develop and manufacture difficult formulations involving poorly soluble molecules.
Plant 1) Class 10,000 (ISO class 7) or better: Preparation and conditioning of liquid, creams, ointments, transdermal gels, nasal sprays, powder in bottle. Maximum batch sizes are 4,000 L for liquids, 200 L for creams and 50 L for ointments using vacuum emulsifier-mixer systems. Conditioning is performed using semi-automatic fillers/sealers.
Plant 2) Class 1,000 (ISO class 6) or better sterile clean rooms with class 100 (ISO class 5 or better) isolators for preparation of sterile liquid or lyophilized injectables. Batch sizes of up to 30,000 vials for liquid and 10,000 vials for lyophilized products. Conditioning may be performed semi-automatically for small batches or automatically. Lyophilization is performed in a fully instrumented Virtis Benchmark 2000 system.
Plant 3-a) Class 10,000 (ISO class 7) or better, CFIA Containment level 2; Bioprocess plant dedicated to the production of biological APIs; fermenters from 40 to 1,900 L.
Total simultaneous batch fermentation capacity: 4,000 L.
Plant 3-b) Class 10,000 (ISO class 7) or better; Multipurpose plant configured for the purification of biological APIs at g to kg scales. Processing equipment includes liquid-liquid extractors 80 L - 1,400 L, vacuum concentrators, industrial centrifuges, ultrafiltration unit, membrane filtration systems, and glass-lined recrytallizers.
Plant 4) Class 10,000 (ISO class 7) or better; We have strong experience in the development of solid dosage forms involving poorly soluble/bioavailable molecules. We produce virtually all variations of tablet cores and coatings using the following equipment:
Low shear and high shear granulators
Type B single punch or multi station presses
Type D single punch or multi station presses
Enteric, standard and sugar coatings using 15, 18 and 24 inches coating pans.
Batch size varies from a few hundred prototype tablets to 500,000 units for phase III clinical studies.
Capsules: We produce standard and enterically coated capsules using semi-automated filling systems with batch sizes up to 100,000 units.