Our expertise goes beyond small molecules. We have significant hands-on experience developing synthetic processes for peptides and oligonucleotide and filing them with regulatory agencies across the globe.

Unit Operations

We have the expertise and capabilities to synthesize and purify medium-sized synthetic molecules. Some examples of what we have done include:

Solid phase synthesis. Since this type of synthesis involves repeated synthetic and washing cycles, this process can be highly inefficient. Our approach leverages reaction engineering and mathematical modeling to remove inefficiencies from each cycle.

Chromatography purification. We have experience with preparative reverse phase chromatography and ion exchange chromatography to purify peptides and oligonucleotides. Our ability to model the process helps minimize the number of experiments required to fully characterize and design this unit operation.

Tangential Flow Filtration. We have experience selecting membranes and designing ultra filtration and diafiltration steps for the purification, concentration, and buffer exchange of both peptides and oligonucleotides. By understanding and modeling the underlying transport phenomena, we deliver practical tools that can be used to simulate what if conditions and to scale up.

Organic Solvent Nanofiltration. We also have experience designing nanofiltration operation for the purification, concentration, solvent exchange and drying of peptides, oligonucleotides. and their precursors.

Freeze drying. We develop freeze drying processes that ensure stability during the drying process, the right cake characteristics, and residual solvent levels that meet specifications. We characterize the primary and secondary drying steps to define operating conditions, and deliver tools that can be used to test what if scenarios.

Enabling Capabilities

Our expertise also encompasses all the key enabling capabilities for process development:

PAT. In addition to traditional off-line samples, we use the right technology to monitor your process. We define and implement sampling schemes and monitoring techniques that best suit your processes.

Modeling, simulation and data science/AI. Modeling and data science are one of our biggest strengths. We are “practical” modelers and data scientists that understand the need for developing scalable process based on detailed understanding of the underlying physicochemical phenomena of the process. Models are an integral part of our development approach, they are used to guide experimentation, design optimal target conditions, and explore operating regions. Our modeling and data science capabilities are extensively “agency tested”. We have experience filing low, medium, and high impact models.

Flow chemistry. Our extensive experience designing, modeling and scaling up continuous processes includes all types of reactors (e.g. CSTRs, MSMPRs, tubular reactors, and packed beds), and enabling operations (e.g. mixing, settling, and fluidization). We also have experience developing and filing residence time distribution (RTD) models to support lot genealogy and diversion decisions. Our capabilities allow us to develop any continuous operation, based on the process needs, and the manufacturing constraints you may have your facilities and/or CMO’s.