Chemical Process R&D

Coupled with the synthesis of process intermediates and GMP raw materials, we also offer cGMP manufacturing of your API in small scale and in production scale. Curia handles small-scale API production critical for discovery and development, GMP scale in Albany and manufacturing at our global API facilities. We handle your cGMP manufacturing needs seamlessly from grams to metric tons — and through all phases of clinical trials — without the need for technology transfer to another company. Whether you require the preparation of API for toxicological studies, Phase I–III clinical trials or commercial supplies, we leverage the expertise and technology to make your project a success.

Curia has the infrastructure to perform rapid scale-up. Our multiple kilo-scale laboratories are equipped for the preparation of cGMP starting materials and other process intermediates on a scale from hundreds of grams to tens of kilograms.

Our capabilities include:

• Multiple jacketed glass reactors from 10 L up to 3000 L capacity
• Large-scale hydrogenation capabilities (up to 80 L GMP and 1000 L non-GMP)
• Synthesis at extremely low or high temperatures with up to 1000 L (-100 °C to 200 °C)
• High-pressure reactions (> 100 psi)
• Large-scale purification equipment (Biotage)
• Dedicated non-GMP and GMP high-potency areas
• Distillation capabilities up to 100 theoretical plates
• Fermentation capabilities

Regardless of scale or complexity, we have the expertise, capacity and capabilities to rapidly meet your custom synthesis needs.

From milligram quantities of a metabolite to several kilograms of a scaffold, we tailor our services to suit your needs, applying a chemical or biocatalysis approaches depending on the complexity of your molecule.

For the quickest turnaround, including the synthesis of reference standards, impurity markers and scaffolds, we offer a rapid scale-up facility.

Our world-class facilities are equipped with the latest in process and analytical instrumentation and offer cost-competitive solutions for your project.

Our skilled scientists have prepared many useful intermediates and scaffolds found in the literature. These compounds are available as part of our building-blocks database.

Equipped with technologically advanced processes and analytical instrumentation, our scientists support all your hazard evaluation needs, offering integrated, continuous service through the drug development life cycle.

During early process development, Curia’s experts conduct a safety evaluation to identify potential issues during scale-up. At that stage and based on our evaluation, we redesign the processes to address all potentially hazardous issues. Backed by experienced process scientists and engineers, the new processes are then demonstrated with fixed equipment in the kilo lab to prove robustness.

Curia’s experts go beyond sample analysis to fix hazardous processes. Leverage our decades of experience in developing safe, efficient and robust processes to help you fulfill your API supply needs.

Our capabilities include:

• Thermal stability assessment: Includes accelerating rate calorimetry (ARC), differential scanning calorimetry (DSC), high-pressure DSC and use of thermal screening unit
• Reaction calorimetry: 200 to 1600 mL, -25 to 200 oC; 0–60 bar; headspace analysis and vent sizing package (VSP2)
• Impact sensitivity testing for potentially explosive compounds: Includes DSC screening and BAM Fallhammer test; routine assessment of impact sensitivity of all compounds exceeding 800 J/g)
• Extensive risk-based assessment sheet: Based on our thorough analysis, a detailed report summarizing the results is provided; we then develop processes to address all concerns

Curia offers extensive expertise, facilities, experience and execution for assessing, developing, and implementing API syntheses that benefit from fermentation, biocatalysis, synthetic biology, and related approaches. Curia’s multidisciplinary approach tightly integrates fermentation and biocatalysis tools with our extensive chemistry capabilities to design and optimize the best overall process for your project.

Curia also offers decades of experience and examples for comprehensive support of programs from innovative Strain/Enzyme Selection and Route Scouting to rapid Pilot-Scale to efficient Commercial Manufacturing. Overall, the integration of biological synthesis approaches  with chemistry and process development offer improved Cost of Goods, new IP, enhanced and simplified process Safety, more efficient and “green” chemistry, and routes to novel molecules, etc.

Our general portfolio of Services includes:

• Fermentation Development and Commercial Manufacturing
• Biocatalysis & Biotransformation
• Natural Product Production, Semi-synthetics and Natural Product Chemistry
• Bioprocess Separations and Development
• Drug Metabolite Synthesis

Expertise in continuous flow chemistry is critical for the development and manufacture of intermediates and APIs, which require technologies that provide safe energy and solvent usage. Our continuous flow processing capabilities offer unique advantages compared with batch processes, resulting in faster, safer and more robust material production with higher selectivity of desired products.

Curia’s facilities are built to suit the chemistry. Our expert equipment and capabilities include:

• Tubular reactors and static mixers to handle multiple batch sizes (mg to kilogram scale)
• Reactions that require micromixing
• Commercial units including a Corning reactor, H-Cube for hydrogenations and custom-built reactors for high-temperature reactions (100–300 °C)
• Ability to scale extreme temperatures (reactions from -78 °C to 150 °C using tubes and tube-in-tube reactors)
• Ability to scale hazardous chemistry
• Access to microwave, photochemistry, electrochemistry and sonochemistry

• GMP Manufacturing (Phase 1-3)
• Preparation of APIs for Nonclinical Safety Studies
• Optimization of Reaction Conditions
• Critical Process Parameter Assessment
• Controlled substances capabilities 
• De-novo route design