Process Development

Introduction

SynCo has a well-established process development team ready to collaborate with you on the development of your biopharmaceutical.

SynCo prefers to get involved early in a development project so that we can assist you in making a rational choice for the expression system, since the choice of expression system is the single most important factor that impacts both (development) timelines and cost of goods in the later commercial phase.

Our philosophy is to “Trust us to make it right”. This means that we do not simply develop a process that will work at the scale of production required for Phase I clinical trials, but we will focus on your long term goals and plan with these in mind. This essentially means that we will develop a process with the eventual commercial scale in mind and scale-down to fit your early phase clinical requirements in the shortest possible time.

Process development at SynCo is goal oriented in the sense that we will stick to proven technologies, resins and filters, i.e. not innovate just for the sake of being innovative. However, how we use the existing technologies can be quite innovative if the project calls for it. New technologies are used if there is a clear scientific need for it from the project perspective, i.e. if the technology is enabling an operation that would otherwise not be possible within the scope and budget of the project. 

This approach has been repeated successfully time and time again, resulting in multiple processes for products that are now licensed biopharmaceuticals. 

Our Process Development team’s experience includes: 

For analytical development, please visit our analytical development page.

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