Process R&D

Asymchem’s analytical expertise and experience in method development and validation are critical to support the design and implementation of chemical processes.

Transforming an early-stage synthetic route into a scalable and reliable manufacturing process requires far more than achieving target chemistry in the laboratory. Process safety, scalability, impurity control, operational robustness, and manufacturing efficiency must all be considered early to support successful industrialization. At Asymchem’s Sandwich site, the Route & Process Enabling workflow is designed to help partners mitigate development risks and accelerate the transition from R&D complexity to practical manufacturing solutions through integrated process development expertise.

At Asymchem, we understand that today's R&D challenges don't have to become tomorrow's manufacturing problems. That's why we are always looking ahead to create the safest, most sustainable, and efficient processes possible. Our Process Enabling workflow offers a cost-effective strategy to mitigate risks during the early manufacturing stages of your target compound.

Our Route Scouting services are designed to identify and demonstrate the most efficient and cost-effective synthetic routes for your target compounds. By leveraging our extensive expertise and advanced technologies, we ensure that your route design is optimised for scalability, sustainability, and regulatory compliance.

At Asymchem we implement Data-Centric Process Design to advance synthetic routes into commercially viable manufacturing processes. Leveraging our advanced technology and extensive experience, our matrix teams take a holistic approach, designing processes that meet the highest standards in line with established SELECT criteria.

In preparation for validation, a comprehensive understanding of the process is essential. At Asymchem we collaborate closely with clients to craft regulatory strategies that guide the generation of the required supporting data. In Sandwich we bring extensive experience in the design and execution of late-stage development packages to support: RSM designation, CPP identification, FMEA/HAZOP, control strategy and regulatory submissions.

Asymchem's Structure Elucidation team plays a crucial role in our comprehensive analytical services, ensuring precise identification and characterization of complex molecules. With over 20 years of experience in problem-solving and structure elucidation within the pharmaceutical industry, our team is well-versed in a wide range of spectroscopy and spectrometry applications.

Asymchem offers a comprehensive stability assessment and testing services to ensure the quality, efficacy and compliance of our client's compounds. Stability studies assess how compounds are affected over time by environmental factors, such as temperature, humidity and light, and are essential for establishing appropriate packaging, storage and transportation conditions, as well as determining shelf life.

Our team has extensive experience in developing and documenting phase-appropriate impurity control strategies for small molecule drug substances, ensuring compliance with global regulatory standards and ICH guidelines.