CDMO Services

Tides

Drawing on Sanofi’s 15 years' experience in the field of oligonucleotides and 45 years in the field of peptides, EUROAPI provides a unique state-of-the-art platform for the development and scale-up of peptides and oligonucleotides at Hoechst Industrial Park in Frankfurt (Germany).

EUROAPI covers the full range of development activities, from clinical phase up to submission and launch, including regulatory support, and commercial supply. 

This Frankfurt site is a pioneer in solid-phase synthesis, and is regularly inspected by the FDA as well as by other International and European agencies. 

Over 15 years' expertise in oligonucleotide development


Oligonucleotides : from lab to GMP production


EUROAPI can provide full development from OP10 to OP100-Synthesizer using semi-automated acetonitrile supply to allow production from mg to g. 


3 Oligo Pilot 100 plus-Synthesizer
In a GMP qualified environment, the Oligo Pilot 400-Synthesizer (GMP)

  • Can operate with 11 different monomers
  • FineLine70 (15 mmol) and 100 (30mmol)
  • UNICORN process control system

State of the art workshop with Oligo Process Synthesizer (GMP)

  • 200, 400 and 600 mm columns
  • Vessels for reagents: 100 to 2500L
  • Vessels for amidites: 5, 10, 25L
  • UNICORN process control system
  • Can operate with 12 different monomers

PPSM module for column packaging, cleavage from resin, and deprotection
 

Oligonucleotides in Frankfurt

Over 45 years' expertise in peptide development

Peptides : from lab to GMP production


EUROAPI can provide a full development pipeline for peptide synthesis with semi-automated solvent supply and waste management due to its industrial location at the Hoechst Park. The Lab equipment includes:

  • cGMP production
  • cGMP production DSP capabilities
  • 2 CS Bio 136 synthesizers
  • 5 CS Bio 536 synthesizers
  • 2 CS Bio Bio 536 (0,25L – 2L)
  • CS Pep process control system

CS Bio 936 / GMP-Synthesizer with fully automated solvent supply from tank farm

  • Reactor volume 10L – 80L
  • CS Pep process control system

Resin Cleavage

  • Resin cleavage and precipitation in 600L vessels
  • Handling of hazardous and noxious chemicals
     
Tides equipement in Frankfurt

cGMP production capabilities

Manufacturing capacities for oligonucleotides and peptides
Two Novasep(TM) GMP chromatography units:

  • Novasep(TM): 3 - 8L/min
  • Columns:    110, 200, 300 mm and 450 mm i.D. HPLC (80-100bar)140, 200, 350 mm i.D. column (3-10 bar)
  • TFF unit: up to 2 x 2.5 m2 filter
  • Rota: 20L and 50L flask, fully automated
  • Freeze dryers: 10kg + 40kg
  • Controlled areas: up to class C, integrated freeze dryer and fraction collection area for prep-HPLC
  • Barrier unit for handling potent APIs

Capacity for cool storage e.g., product solutions.