Zach System is a CDMO company located in Avrillé, France specialized in the production in exclusivity of Active Pharmaceutical Ingredients (API) from Phase I/II to Commercial quantities. Our DNA is to accompany our customers all along the process development activity, the scale-up phases, the validation of processes and method of analysis and the DMF filing.
We are compliant with the highest international standards being inspected by Regulatory Authorities like FDA (USA), ANSM (France), PMDA (Japan), MFDS (Korea). We are also regularly audited by our customers comprising major pharmaceutical and biotech companies. Our plant is also ISO 14001 certified.
In terms of manufacturing capabilities under GMP, we have the possibility to handle API having an OEL down to 1µg/m3 using different equipment size:
• A Kilolab plant with 2 reactors
• A Pilot plant with a total capacity of 5m3 with 11 reactors from 100L to 1000L)
• 2 commercial workshops (reactors in GL and SS from 1m3 to 10m3) allowing us to produce API from 100kg to 150MT/year
We also have special technologies available on site like Spray-Drying, Nano and Ultra-Filtration giving us the possibility to purify macromolecules (peptides like, Carbohydrates, Cyclodextrins, Aminoacid derivatives).
Zach System has a broad range of technologies available on site like:
• Hydride Reduction
• Hydrogenation (10 bar)
• Lithiation
• Low Temperature Reaction
• Ozonolysis
• Grignard
• Cyanation
• Suzuki coupling
• Etc…
We can handle many different dangerous reagents like LAH, BH3/THF, DMS, Acetylene, KCN, NaCN, Li in liquid Ammonia, Propylene Oxide, H2O2, Epichlorhydrin, etc…
Zach System R&D offers process / analytical development services and full process safety assessment for new and existing products manufactured on site. Our technological offer is enriched by specialist know-how in flow chemistry and particle engineering.
A team of experienced chemists and analysts provide extensive know-how for active ingredients and intermediate stages. The product development is supported by a pool of highly professional project managers and dedicated sourcing specialist.
R&D facilities allow carrying out a wide variety of organic reactions both in batch and flow. This covers conditions from -90° to 150°C and up to 12 bars up to kg-scale. Separate and closed laboratory areas allow handling high potency ingredients (down to an OEL of 1 μg/m³) under totally safe conditions.
A wide number of equipment is available to support the process development: jacketed reactors, micro-reactors (IMM™FFMR, Corning AFR™-LF, Vapourtec R-Series), PAT probes (FTIR, turbidimetry, NMR, RAMAN, FBRM).
Safety assessment is supported by thermal analyses (DSC, TGA) and reaction calorimetry (RC1, 1RC).
Particle engineering utilizes both in silico (modeling and statistical software) and lab utilities (automated workstation, lab-scale agitated filter dryer and centrifuge, customized glassware, Crystalline, spray-dryer) as well as extensive solid-state, morphology and rheology characterization (XRPD, microscope, rheometer, Flodex, Shear-cell test, Malvern PSD analysis).
Customized flow reactor plates and process accessories (stirrers, baffles) are 3D-printed in house.
The chemical development is supported by state-of-the-art equipment: HPLC/UPLC (UV-VIS, RID, CAD, MS detection), GC, HS-GC and wet chemistry devices. Structural characterization is assured by LC-MS (ion-trap, TOF), GC-MS, NMR, IR, UV.