Your Industrial Chromatography Partner for Drug Substance Manufacturing
Industrial chromatography is a cornerstone technology for separating and purifying complex mixtures in drug substance manufacturing. By leveraging selective interactions between molecules and stationary/mobile phases, chromatography ensures precision and reliability throughout the entire lifecycle - from early laboratory screening to pilot scale and full commercial production.
At Evonik, we design robust, scalable purification processes for the manufacture of active pharmaceutical ingredients (APIs) and intermediates. These processes support every stage of development, including early research, clinical trial supply, and commercial manufacturing.
Why Chromatography Is Critical for API Quality and Compliance
Chromatographic purification directly impacts the success of your drug substance:
- Purity & Quality: Effective removal of impurities and side-products
- Efficiency & Recovery: Selective isolation of target compounds
- Consistency: Reproducible performance across scales and batches
- Versatility: Applicable to small molecules, peptides, amino acids, PEGs, lipids, and complex molecules
- Scalability: From early-stage development to large-scale manufacturing
- Regulatory Compliance: Meeting global standards for residuals and impurities to ensure patient safety
Our Holistic Approach to Chromatography Development
We combine scientific expertise with advanced technologies to deliver customized purification solutions. Our chromatography strategy is built around three key stages:
At the start, we focus on understanding the molecular behavior of your compound and its separation potential. This includes evaluating binding interactions, selecting the most suitable solvents and resins, and using AI-driven gradient screening to accelerate decision-making. Thermodynamic profiling, such as adsorption isotherms, helps us predict performance and design the most effective purification strategy.
Once feasibility is confirmed, we refine the process to maximize yield and minimize resource consumption. Our team selects the optimal chromatography mode and equipment, controls elution profiles, and develops fractionation strategies for precise separation. Advanced tools like CADET-Process simulation allow us to model and optimize performance before scale-up, reducing risk and improving efficiency.
Finally, we ensure seamless transfer from lab to production scale. This involves adjusting column geometry, bed height, and flow rates to maintain performance at larger volumes. We conduct rigorous quality and risk assessments, implement cleaning protocols, and support the transfer of existing customer processes to our facilities. The result: robust, reproducible purification processes ready for commercial manufacturing.
Advanced Chromatographic Processes
Our expertise enables intensified, high-performance solutions:
- Continuous Chromatography (Simulated Moving Bed) for higher productivity
- Continuous Ion Exchange Chromatography
- Recycling Chromatography to enhance yield
- Displacement Chromatography
- Integration of Reaction & Separation
Your Overview of Our Chromatography Development & Process Capabilities
- Flash cartridges up to 5 L
- PrepHPLC columns up to 0.5 L
- Low pressure columns up to 50 L
- Continuous Chromatography (low pressure) up to 12 L
- Continuous Chromatography (high pressure) up to 0.5 L
- Process scalability: From kilograms to metric tons
Accelerate Your Drug Project with Evonik
Ready to optimize your chromatography process for API manufacturing? At Evonik Health Care, we combine decades of expertise with cutting-edge technologies to deliver reliable, compliant, and efficient purification solutions tailored to your needs.
ANY QUESTIONS? JUST CONTACT US.
"Exploring options for the development and manufacture of your cGMP small molecule drug substance or associated intermediates? Reach out and we'll help you make well informed choices as Evonik aims at getting clients practical solutions faster and easier."
Eric Neuffer
Head of Drug Substance Sales
