Manufacturing Services Europe

Services

Together with our longstanding network of carefully selected EUROPEAN associates and unique subcontractors (CRO/CDMO) that are fully committed to comply with our various agreements and policies we are offering a reliable, comprehensive and transparent service for:

Custom / Contract Manufacturing / Tolling (cGMP and non-GMP)
Custom synthesis on FTE & FFS service model (CRO)
Literature and Patent Research
Process Research
Process Development
Bench-Scale Lab, Kilo Lab and Pilot Plant Development
Process Optimization
Commercial manufacturing

Small Molecules / New Chemical Entities / Tailor made complex molecules

Large scale non-GMP or GMP

Core technologies:
Hydrogenation
Grignard
Bromination with Br₂
Chlorinations with chlorinating agents
Claisen-Dieckmann reactions
Friedel-Crafts reaction
Chemical reduction

High pressure:
max. 120 bars, 300°C

Medium pressure:
1 hydrogenator 2,5m3(loop) stainless
steel 40 bars, 160°C
1 hydrogenator 2,5m3(vertical reactor)
12 bars, 160°C

Low pressure:
1 reactor 3 m3, 5 bars, 160°C

Glass lined and stainless steel reactors:
Up to 300°C oil heat,180°C steam heat, Pressure up to 3 bars

Distillation:
Colmun with max12 plates, 4m3 glass lined distillator.
High temperature up to 160°C, pressure 3 mbars, 1 Short Path distillator

15 dryers, filters and centrifuges

TIDES: Nucleotides, Oligonucleotides and Peptides

Oligonucleotides:
Small to commercial-scale cGMP and non-GMP manufacturing by liquid phase synthesis (LPS)
Small-scale by solid phase synthesis (SPS)
Custom manufacturing with modifications to backbone linkages, sugars, bases
Multi-scale cGMP and non-GMP manufacturing of side-chain and linker drug modifiers

Multiscale cGMP and non-GMP manufacturing of high-purity nucleotides including nucleoside phosphoramidites

Peptides:
Small to commercial-scale cGMP and non-GMP manufacturing by liquid phase synthesis (LPS)
Small-scale manufacturing by solid phase synthesis (SPS)
Custom synthesis of natural and unnatural amino acids
Multi-scale cGMP and non-GMP manufacturing of side-chain and linker drug modifiers

Biologics Development and Manufacturing

Fed-batch, N-1 perfusion and full perfusion processes up to 6x2000L (cGMP)

For Bio APIs from cell of human or animal origin or for aseptic clinical samples (for analytical tests)

Services include
Cell Line Development
Process Development / Optimization
Method Development
Pilot scale manufacturing
Next Generation Technologies
Technology Transfer
Process Characterization
Support for BLA/MAA submissions

Complex synthesis including ADC linkers, payloads and Conjugates

Development
scale-up and
commercial manufacturing of linkers-payloads

Commercial production (up to 100 MT) involving:

Acid chloride preparations
Carbene additions
Cyanations
Cyclopentadiene chemistry
Cyclopropanation
Diazoacetate reactions
Diazotizations
Friedel-Crafts reactions and isomerizations
Halogenations
High temperature reactions
Hydrogenations
Optical resolutions
Oxidations
Reductions

Cryogenic reactions at up to 1,000 litre scale routinely handle
Grignard reagents
Hexyl lithium
Metal hydrides
Organozinc reagents

Special experience in metal-mediated coupling reactions
Heck
Sonagashira
Suzuki

Supporting cGMP up to pilot plant scale

GMP Manufacturing Capabilities of Polymer & Lipid-based Therapeutics

kg scale GMP manufacturing of polymers & Lipid excipients, Polymer-conjugate Drug Substances

Preclinical Development
Technology Transfer
GMP Manufacturing
Drug Product Formulation, Fill & Finish services to support clinical development
Method Development, Validation & ICH stability studies
CMC Regulatory support for IND & BLA submission

Fast Track projects for GMP or non-GMP up to 250 MT involving

Acid halides synthesis
Amidation
Bromination (for e.g. 3-4 step synthesis)
Coupling (Suzuki, Kumada…)
Cyclization
Dehydration
Dehydrohalogenation
Esterification (including tert-butyl esterification)
Friedel and Crafts
Grignard reagents synthesis and use
Ketalisation
Metalation (n-Butyllithium) or organometallic reactions
Reduction (Wolff Kishner or Hydrides)

Precision Fermentation

Fermentation based production - from strain development to commercial scale

Strain development
Process optimization
Large-scale manufacturing