In addition to four process research and development laboratories our state-of-the-art infrastructure includes manufacturing capabilities for small batch sizes of up to 10 -15 kg.
The specialized laboratories and kilo-scale manufacturing equipment are designed to operate safely at or below 1 µg/m³ OEL. This specification allows safe handling of highly-potent
compounds of all categories including cytotoxics/cytostatics.
Our manufacturing equipment at intermediate scale of up to 630L currently operates at or below 100 µg/m³ OEL. With the dedicated expansion in Bavla, India our large-scale manufacturing
capabilities allow a safe operation at or below 1 µg/m³ OEL on a scale up to 1’600 L producing batches in the 200 kg range.
Our facilities and equipment include:
- Laboratories designed to operate at or below 1 µg/m³ OEL; Air Cleanliness Class ISO 7 (Class 10,000) utilizing barrier isolation technology
- Kilo-scale manufacturing facility designed to operate at or below 1 µg/m³ OEL utilizing barrier isolation technology, capability to operate to Cleanliness Class ISO 7 (Class 10,000)
- 4 Reactors from 100 L to 250 L (hastelloy and glass-lined), temperature range from -100°C to +160°C, pressure up to 12 bar
- Hastelloy Filter Dryer in glove box (0.125 m2)
- Intermediate-scale production facility designed to operate at or below 100 µg/m³ OEL utilizing “split-butterfly valve” and barrier isolation technology:
- 3 Reactors from 250 L to 630 L, temperature range from -100°C to +160°C, pressure up to 25 bar
- Hastelloy Filter Dryer (0.25 m²)
- Large-scale production facility designed to operate at or below 1 µg/m³ OEL utilizing barrier isolation technology:
- 4 Segregated High Potency Handling Cells of which 2 equipped
- 2 cells containing 3 reactors from 630 L to 1’600 L and a Hastelloy Filter Dryer (1.0 m²)
- Charging and discharging of reactors and stirred filters via isolators
- Expansion possibilities up to 6’300 L
- Particle size reduction capability
To complement our services for highly potent APIs we have dedicated analytical and purification capabilities including:
Analytics of Highly Potent APIs
- NMR
- HPLC (SEC-UV, GPC-MALLS, HPLC-MS)
- GC (FID, Headspace)
- pH meter
- UV/VIS
- IR (KBr pellet)
- KF-determination
- DSC (closed pan only)
- Heavy metals
- Residue on ignition
- Optical rotation
- RC1
- Access to crystallization development and screening for metastable zones in closed vials
- Access to powder X-ray diffraction and particle size determination
Purification of Highly Potent APIs
- Preparative HPLC 5 cm ID
- Tangential Flow Filtration for macromolecules from 10’s to 100’s of kilo Dalton
- Gel Permeation Chromatography for the removal of aggregates and higher molecular impurities
