We have extensive hands‑on experience developing and filing small‑molecule processes with regulatory agencies across the globe. Our process expertise spans a wide array of unit operations, from chemical reactions and separations to crystallization and particle engineering. To design and develop your process, we combine the deep experience of our team with the strategic use of enabling technologies.

Unit Operations

We have the expertise and capabilities to develop all unit operations required within a synthetic route. Examples of our experience include:

Reactions. We have experience with a variety of reactions, including condensation reactions, C-C cross-coupling reactions, hydrogenations, homogeneous and heterogeneous catalysis, protection and deprotection, and nitrosation reactions to name a few. Moreover, we have experience with different operation modes, including batch, semibatch, and continuous reactions.

Work‑ups. We have extensive experience efficiently developing and optimizing extractions, quenches, distillations, and solvent exchange operations through targeted experimental design informed by thermodynamics.

Adsorptions. We have significant experience in developing impurity scavenging and water removal processes using adsorbents. Our expertise in mass transfer and thermodynamics makes our development process highly effective and efficient.

Crystallizations. We design portable crystallizations and isolations. We have the tools and the knowledge to undertake complex crystallization development, particularly those processes where many drug substance critical quality attributes need to be met (form, purity profile, particle size). While quality is paramount, we keep in mind our client’s business goals (yield, cycle time, process greenness) and make relevant recommendations to ensure process robustness and scalability. We specialize in developing open/close loop crystallization policies that can be scaled up confidently. Based on our vast experience developing crystallizations, we avoid overengineering operations that do not translate well at large scale due to additional complexity or lack of access to specific technology at manufacturing facilities. From simple kinetics of growth and nucleation, to multidimensional population balances, our team develop robust crystallization processes.

Milling. Our team has pioneered several new methodologies to design and scale up wet milling and dry milling operations. We characterize the main phenomena that affect particle size or form, including particle breakage and form transformation rate and build scale independent milling curves that can be translated between equipment and minimize the number of experiments.

Filtration and drying. We characterize filtration to understand scalability. We develop drying operations that ensure solvent removal but also more complex desolvation/dehydration/humidity-controlled processes to achieve the desired crystalline form at the drying end point.

Co-processing. We have experience developing co-processing steps for starting materials, intermediates, and drug substances, using a diverse set of techniques such as coprecipitation and incipient wetness impregnation.

Enabling Capabilities

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 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 physico-chemical 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 have been extensively “agency tested” through the filing of several mathematical 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 material diversion decisions. Our capabilities allow us to develop any continuous operation, based on the process needs, and the manufacturing constraints you may have at your facilities and/or contract manufacturing organizations.