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Equipment for Highly Potent Drug Substances (APIs)

Our state-of-the-art infrastructure includes process research and development (PR&D) laboratories, one laboratory dedicated to conjugation of small and large molecules and manufacturing capabilities.

The specialized laboratories and kilo-scale manufacturing equipment for small batch sizes of up to 10 -15 kg are designed to operate safely at 0.01 g/m³ OEL. This specification allows safe handling of highly potent compounds, including cytotoxic warheads applied in antibody drug conjugates (ADC).

Our intermediate and large scale manufacturing equipment currently operates below 1 g/m³ OEL (Switzerland) or at 0.05 g/m³ OEL (India) on a scale up to 1'600 L producing batches in the 200 kg range.

Our facilities and equipment include:

Bubendorf, Switzerland


  • 4 PR&D laboratories designed to operate at 0.01 g/m³ OEL; Air Cleanliness Class ISO 7 (Class 10,000) utilizing barrier isolation technology
  • Conjugation laboratory with Grade C and D areas designed to operate at 0.01 g/m³ OEL;
  • Kilo-scale manufacturing facility designed to operate at 0.01 g/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)
    • Hastelloy Filter Dryer with glove box (0.3 m²) attached.
  • Intermediate-scale production facility designed to operate below 1 µg/m³ OEL utilizing Rapid Trasfer Ports (RTPs), barrier isolation technology and flexible containment of technology key equipment,
    • 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)

Hunzenschwil (Neuland), Switzerland


  • 1 PR&D laboratory designed to operate below 1 g/m³ OEL
  • Intermediate-scale production facility designed to operate at 1 µg/m³ OEL (Category 3) utilizing flexible containment technology of key equipment.
    • 4 Glass-lined reactors of 630 L (2x) and to160 L (2x), pressure up to 6 bar
    • 2 Filter Dryers (0.27m² and 0.15 m2)

Bavla, India


  • 2 PR&D laboratory designed to operate below 0.1 µg/m³ OEL
  • Kilo-scale manufacturing facility designed to operate below 0.1 OEL, capability to operate to Cleanliness Class ISO 8 (Class 100,000)
    • 3 Reactors from 80 L to 50 L (hastelloy and glass-lined), temperature range from -80°C to +160°C, pressure up to 10 bar
    • Hastelloy Filter Dryer (0.8 m²)
  • Large-scale production facility designed to operate at 0.05 µg/m³ OEL utilizing barrier isolation technology:
    • 6 Reactors from 630 L to 1'600 L
    • Hastelloy Filter Dryer (1.0 m²) fitted with a discharging isolator
    • Hastelloy Filter Dryer (0.6 m²) fitted with a discharging isolator
    • 6 Isolators dedicated to charging and one to dispensing
    • Isolator for milling/micronization (Nara Pin Mill, Quadro Mill and Sturtevant Jet Micronizer)

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
  • Malvern particle size distribution (PSD)

Purification of Highly Potent APIs


  • Grade-D suite dedicated to high potency chromatography
    • Equipped with 3 Walk-in-Barrier Hoods
    • Preparative HPLC 5-20 cm column
    • Explosion Proof (ATEX) Designed
    • cGMP compliant
  • 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

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News
21 July 2017
CARBOGEN AMCIS Sites at Bubendorf, Aarau and Neuland in Switzerland Successfully Pass Swissmedic Inspection

11 August 2016
Dishman Celebrates a Decade of Success Since Acquisition of CARBOGEN AMCIS

14 July 2016
CARBOGEN AMCIS Sites at Aarau and Neuland in Switzerland Successfully Pass FDA Inspection


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