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SpiroChem's process and scale-up chemists take a unique and innovative approach to problem-solving the distinct challenges of chemical process R&D experienced by biotechs, global pharmaceutical companies and CDMOs. Our strategic approach ensures timely pre-clinical supply, taking process R&D challenges into account to design the best routes and processes and facilitate future clinical supply.
At any stage of chemical process R&D, we ensure you get the best out of the scale-up process - seamlessly transitioning from milligram to kilogram scales. Our dynamic team of experts can provide synthesis of crucial intermediates and APIs for pre-clinical toxicology studies.
Our best-in-class approach integrates the latest advancements in the field in a cost-effective and environmentally conscious way. With a strong track record in pharmaceutical manufacturing support, we specialize in isolating, identifying, and synthesizing process impurities, contributing to enhanced analytical process R&D, and meeting regulatory benchmarks.
Safe and scalable routes
Intermediates and APIs
Syntheses with reduced raw material costs
Syntheses with exceptional quality and speed
Analytical method development
Batch release testing
At SpiroChem, our approach involves comprehensive analysis and assessment of several factors, such as reaction yields, selectivity, scalability, cost-effectiveness, safety, and environmental impact. We prioritize routes that minimize the use of hazardous reagents or generate less waste, aligning with the principles of green chemistry.
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Our team of experienced professionals specializes in facilitating efficient and effective tech transfer, ensuring the successful transition of manufacturing processes, analytical methods, and quality control procedures. We are also well-versed in the tech transfer to both internal process groups at pharma companies and CDMOs.
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At SpiroChem, we follow a systematic approach, meticulously designing and planning the demo batch to ensure accurate representation of the process and its robustness. We typically perform demo batches in our kilo-lab using the newly developed manufacturing process to deliver the required quantities of product.
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Our expert team specializes in impurity synthesis, offering services in the identification, replication, and characterization of process impurities associated with the manufacturing process to the target API. Our commitment to excellence in impurity synthesis optimizes product quality and enhances chemical and pharmaceutical manufacturing processes by facilitating analytical method development and validation, as well as process validation at large. We also have experience in the extraction, isolation and identification of process impurities and other unknown molecules.
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At SpiroChem, analytical method development efforts focus on streamlining analytical workflows, minimizing sample preparation time, and maximizing instrument productivity to achieve higher throughput and efficiency. We routinely perform analytical method development in our projects and have developed expertise in that field using different chromatographic systems. These methods may be used directly or as a basis for in-process controls.
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We are key partners for the production and supply of high-quality reference standards, ensuring accuracy, reliability, and traceability. We provide standards that accurately represent target compounds together with meticulous documentation, enabling their use as benchmarks for quality control and analytical testing.
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