Speed
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API Intermediate by a Chiral Synthesis
Benefit for Customer:
- fast delivery of product
- additional services like stability studies
- improved selectivity
- low temperature reaction
The goal was the scale-up of a six step synthesis to form a chiral intermediate, to validate the process and have the first
quantities produced within 6 months under cGMP. The previous supplier of the intermediate dropped out of the business leaving the
customer with the urgent need for an alternative supplier. The tech transfer was achieved within 6 months. The synthesis
included a diastereomeric condensation step at -70 °C. Despite the urgency of the project, RohnerChem was able to implement
several improvements during the scale-up, e. g. the yield and the quality of the last step could be dramatically improved, resulting
in lower costs for the customer.
Flexibility
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Superior Quality
Benefit for Customer:
- robust down stream processes
- reliable quality and delivery
The goal was to improve the quality of an intermediate produced for a pharmaceutical company. A non-detectable impurity
caused quality problems in the consecutive API-synthesis at the customer’s site. In collaboration with the customer,
the process parameters were optimized in order to avoid the critical impurity. Due to the several measurements, the product
quality could be improved. Based on this success, the customer entered in a multi-year supply agreement.
Reliability
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Sulfur Containing Anilines – Unique Methodology
for Complex Building Blocks
Benefit for Customer:
- reliable supply of unique aromatic building blocks
- more efficient syntheses
The goal was to produce a sulfur containing aniline on large scale. The product is synthesized in a two step process.
In the first step a chloro nitro arene is substituted by a thiolate, and in the second step the nitro group is reduced to the aniline.
Using classical hydrogenation technology the catalyst was poisoned immediately by residual thiol impurities. Therefore, RohnerChem
used HTC (Hydrogen Transfer Catalysis) - the in house developed methodology for reduction of nitro groups. The HTC catalyst was
not poisoned at all. More than one hundred tons of the desired product has been produced reliably over the years.
Scale-up
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API Synthesis Using Chiral Pool
Benefit for Customer:
- complex API synthesis
- improved yields and quality
- optimized process development schedule
- transparent and optimized cost structure
The goal was the development and scale-up of an eleven-step laboratory synthesis and the production of several hundred kilograms
of the API under cGMP. The synthesis of the API was adapted quickly and the first production in the pilot plant was started
within 4 months. While the last steps of the synthesis were still running in the pilot plant, the large-scale production was already
started. Due to this parallel approach and a sound project management, the API could be delivered several months earlier than
scheduled. The process development included a process optimisation initiative, which resulted in significantly higher yields, reduced
reaction times and improved quality of the final product resulting in a substantial cost benefit for the customer.
