Our expertise goes beyond small molecules. We have significant hands-on experience developing synthetic processes for medium-sized 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. Examples of our experience 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 and improve performance.

Conjugation reactions. We have experience with a range of conjugation strategies, including the conjugation of peptides to peptides as well as peptide–oligonucleotide conjugates. 

Chromatography purification. We have experience with preparative 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 hands-on 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 operations for the purification, concentration, solvent exchange and drying of peptides, oligonucleotides and their precursors/fragments.

Freeze drying. We optimize 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.

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

Process Analytical Technology (PAT). In addition to traditional off‑line analysis, we apply fit‑for‑purpose analytical technologies to monitor processes during development—while ensuring these tools can be cleanly removed or adapted for manufacturing. We define and implement sampling strategies and monitoring approaches tailored to the specific needs and constraints of each process.

Modeling, simulation and data science/AI. Modeling and data science are among our greatest strengths. Given the complexity of the TIDES process, these capabilities have an even greater impact than in small‑molecule development, reducing costly experimentation and enabling successful technology transfer.

Flow chemistry. We bring extensive experience in designing, modeling, and scaling up continuous processes, which is particularly valuable for TIDES. Our capabilities enable traditional TIDES unit operations—typically executed in batch mode—to be redesigned as continuous or intermittent processes. We tailor each design to the manufacturing constraints of your facilities and/or your contract manufacturing organizations.