Home > Our Capabilities | Skills and Experience
We recognize that the most difficult and important parts of process development of new drug API/advanced intermediates are Technical Transfer and Scale-Up. Even a sophisticated and well-defined process may well wreak havoc when it comes to large scale production.
To achieve success, Sumitomo believes that the most important factors are:
a Skilled Project Team & Close Communication with the provider.
With ample track record in scale-up and process validation, our team knows WHAT TO DO and HOW.
Comprehensive Approach
Even a successful process in one site may not work in another site because a certain process does not align well to certain equipment and supporting systems. When our process team evaluates a process not only process scalability but also process-equipment matching is taken into consideration. Process scalability evaluation encompasses every aspect of the process. This also includes hazard evaluation,& regulatory compliance confirmation. One of Sumitomo’s biggest strengths is its internal capability of hazard/safety evaluation of every aspect of chemical process. This enables us to achieve quick and safe scale-up.
 Dust explosion testing in Sumitomo |
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 Assessment of Runaway Reaction in Sumitomo |
Experience and truck record
Multiple projects per annum have been successfully transferred to Sumitomo. Sumitomo also has chemists specialized in technical transfer in each site. Skilled scientist teams in each site and R&D center closely work together for successful technical transfer of all types, i.e. between Customer and Sumitomo, between R&D lab and commercial site, and between two commercial sites.
Sumitomo believe close communication with customer is the key for successful technical transfer. Our approach includes;
Consensus on the scope of the technical transfer
The term “technical transfer” is rather vague and so may give evoke different approaches between two parties. Therefore, prior consensus on the scope of the transfer, milestone, and schedule is an integral part of technical transfer. And we nurture the idea of clear consensus.
Transparency
Once a project starts, the factor with utmost importance is transparency. Through frequent conference call and e-mail reporting, Sumitomo has been successfully managing technical transfer from US and European Customers.
In the course of the development of advanced intermediates and APIs, a multi disciplinary task is required in the field of analytical development.
Sumitomo’s dedicated analytical R&D team has vast experience in analytical support to the pharma industry from product characterization to analytical method development.
One indicator of such experience is the track record of analytical method development and validation.
Our analytical R&D team develops and validates more than 50 analytical methods per year.
Even when a robust process is transferred by experienced and skilled scientists, unforeseeable trouble is almost destined to happen.
One of Sumitomo’s biggest area of expertise is in its trouble shooting skill. Below are only a few examples of our expertise.
The API process transferred from a major European pharma was well characterized and parameters were set by the customer. The longer time cycle and resulting longer exposure of intermediates to heat because of scale-up, however, was not taken into account.
Sumitomo detected that a new impurity is generated if the process is scaled-up. Through the following investigations, Sumitomo identified the structure of the impurity, confirmed the route of the formation of the impurity, and identified the step that caused the impurity formation. Sumitomo's technical team re-assessed the relevant parameters and proposed to the customer modification of the critical step. The modification was approved by the customer and the process was validated.
All steps from detection to proposal were completed within 1.5 months.
In its developmental stage, not only the process for API manufacture but also the process for starting materials may not be well characterized.
For an API project in its developmental stage, a starting material had been supplied by the customer. During its receiving process, Sumitomo detected a new impurity in one lot of the supplied starting material. Sumitomo identified the structure of the impurity and confirmed that the impurity can be carried over to the API by use-test. Sumitomo also confirmed that the impurity cannot be removed by reprocessing and thus established a re-work method and proposed it to the customer.
The whole steps from the detection to the proposal were completed in 2 months.
