Great results don't happen by chance—they're built on the right expertise. Let's take a closer look at one of the services that helps our customers turn complex challenges into smart solutions.
For therapeutic oligonucletides, process development is the step that determines whether a sequence can become a reliable manufacturing reality. In other words, it is where a robust, scalable manufacturing process is developed for your oligonucleotide candidate. For therapeutic oligonucleotides, this means translating their sequence into a well-understood, reproducible production process, fit for large-scale manufacturing and with the required quality for clinical supply, with commercialization already on our minds.
At BioSpring, process development can always be started immediately, with no lead-time. Our typical first step is the so-called "familiarization". Here, we evaluate sequence composition, chemistry, and modifications of your target molecule. This assessment is then applied to our established manufacturing platforms, focusing on the most important process parameters, e.g. starting materials, bed heights, flowrates, etc. This process enables a rapid yet systematic definition of suitable upstream and downstream processing steps, tailored to each molecule.
In essence, our platform process provides the reliable starting point for all process development work and is based on sophisticated know-how we acquired over three decades of manufacturing more than 100,000 oligonucleotides. It enables a robust baseline while still allowing for easy customization and targeted optimization where needed.
Process development at this stage is supported by purity-indicating analytical (HPLC-MS) methods that ensure sufficient resolution to draw first conclusions about molecule-specific characteristics and the purity/impurity profile. Though these analytical methods are usually further developed for better resolution later on, they do already allow targeted adjustment of key process parameters such as coupling times, temperatures, and buffer compositions to optimize the process with regards to yield, purity and robustness.
By combining platform know-how with molecule-specific optimization, we enable efficient and fast scale-up, reduce development risk, and create the foundation for long-term manufacturing performance.
In brief
Our process development services support the efficient clinical progression and seamless upscaling of therapeutic oligonucleotide programs, including:
-
Structured process familiarization based on BioSpring’s platform technology, adapted to each molecule’s sequence
-
Flexible adjustment of key process parameters such as coupling times and reaction conditions
-
Development of impurity-aware process strategies to support high full-length purity and robust recovery
-
Delivery of scalable, transferable processes ready for large-scale GMP manufacturing