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ISOCHEM in action: business case studies
ISOCHEM’s ability to bring ‘The Right Chemistry’’ to bear on customer needs can routinely deliver success for challenging projects.
The following business case studies provide examples of the potency of ISOCHEM’s custom development and manufacturing capabilities.
Phase I advanced intermediate: 100 Kg delivery
ISOCHEM was able to achieve fast development and scale-up from lab procedure for an advanced intermediate.
It rapidly developed a production process that avoided costly double filtrations and problematic use of Dichloromethane Methylene Chloride (DCM).
Using minimum R&D for secured scale-up, ISOCHEM was able to move the customer to production of the first 100 Kg batch just four months after kick-off.
The project delivered an additional bonus in the form of an offer for a superior 2nd generation process, also developed by ISOCHEM.
Pre-launch regulated intermediate: multi-tonne production
This case study highlighted ISOCHEM’s ability to deliver rapid industrial technical transfer, in this case enabling multi-tonne production of a pre-launch regulated intermediate.
ISOCHEM was able to complete a successful demonstration run only three months after project Kick-off, moving into full-size batch production just a month later.
Significant contributions from ISOCHEM to the project included product quality and supply chain logistics as well as support for Quality Assurance (QA).
The client also benefited from further yield and production efficiency improvements over the subsequent 12 months.
Generic API: new supplier
ISOCHEM was able to play a vital contribution to rapid development and regulatory filing for a new API supplier, developing a two-step production process from scratch.
The project achieved scale-up and process validation within nine months, delivering full filing data to the customer in time for market registration.
ISOCHEM contributed analytical development and validation in addition to Pharmacopeia alignment, screening for genotoxic impurities (GTIs) and residual solvents.
Tolling hydrogenation of an intermediate
ISOCHEM demonstrated its abilities in rapid tech transfer and production in developing a tolling hydrogenation process for an intermediate, after the client had experienced process scale-up issues with a previous CMO.
Within one month, ISOCHEM had completed familiarization and scale-up preparation, ready for two successful batches to be produced the following month.
ISOCHEM is now regularly undertaking 10 tonne hydrogenation campaigns of the intermediate.