HomeOur Capabilities | Skills カジノシークレット やばい Experience
We recognize that the most difficult カジノシークレット やばい important parts of process development of new drug API/advanced intermediates are Technical Transfer カジノシークレット やばい Scale-Up. Even a sophisticated カジノシークレット やばい well-defined process may well wreak havoc when it comes to large scale production.
To achieve success, Sumitomo believes that カジノシークレット やばい most important factors are:
a Skilled Project Team & Close Communication with カジノシークレット やばい provider.
With ample track record in scale-up カジノシークレット やばい process validation, our team knows WHAT TO DO カジノシークレット やばい 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 カジノシークレット やばい 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 カジノシークレット やばい safe scale-up.
 Dust explosion testing in Sumiカジノシークレット やばいmo |
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 Assessment of Runaway Reaction in Sumiカジノシークレット やばいmo |
Experience カジノシークレット やばい 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 カジノシークレット やばい R&D center closely work together for successful technical transfer of all types, i.e. between Customer カジノシークレット やばい Sumitomo, between R&D lab カジノシークレット やばい commercial site, カジノシークレット やばい between two commercial sites.
Sumitomo believe close communication with customer is カジノシークレット やばい key for successful technical transfer. Our approach includes;
Consensus on カジノシークレット やばい scope of カジノシークレット やばい technical transfer
The term “technical transfer” is rather vague カジノシークレット やばい so may give evoke different approaches between two parties. Therefore, prior consensus on the scope of the transfer, milestone, カジノシークレット やばい schedule is an integral part of technical transfer. カジノシークレット やばい we nurture the idea of clear consensus.
Transparency
Once a project starts, the factor with utmost importance is transparency. Through frequent conference call カジノシークレット やばい e-mail reporting, Sumitomo has been successfully managing technical transfer from US カジノシークレット やばい European Customers.
In the course of the development of advanced intermediates カジノシークレット やばい 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 カジノシークレット やばい pharma industry from product characterization to analytical method development.
One indicator of such experience is the track record of analytical method development カジノシークレット やばい validation.
Our analytical R&D team develops カジノシークレット やばい validates more than 50 analytical methods per year.
Even when a robust process is transferred by experienced カジノシークレット やばい skilled scientists, unforeseeable trouble is almost destined to happen.
One of Sumiカジノシークレット やばいmo’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 カジノシークレット やばい parameters were set by the customer. The longer time cycle カジノシークレット やばい 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, カジノシークレット やばい identified the step that caused the impurity formation. Sumitomo's technical team re-assessed the relevant parameters カジノシークレット やばい proposed to the customer modification of the critical step. The modification was approved by the customer カジノシークレット やばい the process was validated.
All steps from detection カジノシークレット やばい proposal were completed within 1.5 months.
In its developmental stage, not only カジノシークレット やばい process for API manufacture but also カジノシークレット やばい 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 カジノシークレット やばい 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 カジノシークレット やばい thus established a re-work method カジノシークレット やばい proposed it to the customer.
カジノシークレット やばい whole steps from カジノシークレット やばい detection to カジノシークレット やばい proposal were completed in 2 months.
