Downstream Processing Services

Our Downstream Processing services are tailored to ensure the efficient and cost-effective purification of biologics, enabling the production of high-quality biosynthetic products at commercial scale. From small molecules and recombinant proteins to monoclonal antibodies downstream processing is crucial for isolating, purifying, and characterizing the biologic product to meet the required standards of purity, stability, and activity. With our extensive experience in both mammalian and microbial systems, we provide robust solutions to maximize yield and ensure regulatory compliance throughout the entire purification process.

Our Downstream Processing Expertise

Rodon’s team has a deep understanding of the challenges involved in biologic purification and works with a wide range of advanced technologies to optimize recovery, reduce costs, and ensure consistency. We offer a full spectrum of downstream processing services to support the production of your biologics, from early-stage development to commercial-scale manufacturing.

Harvest & Clarification

The first step in downstream processing is the efficient removal of cells, debris, and other impurities from the fermentation or cell culture medium. At Rodon, we employ advanced techniques to maximize recovery and clarity, ensuring that the downstream process can proceed with minimal contamination.

• Cell Harvesting: Efficient separation of cells and cellular debris through centrifugation, depth filtration, or tangential flow filtration (TFF).
• Clarification: Removing remaining particulates to ensure that the clarified supernatant is suitable for the next stages of purification.s for proper functionality.
  
  

Chromatography Development

Chromatography is a key purification step, enabling the separation of the target protein or biologic from other components in the mixture. At Rodon, we design customized chromatographic workflows that are optimized for each molecule's unique properties, ensuring high purity and high yield.

• Affinity Chromatography: Using specific binding interactions (e.g., Protein A, His-tag) to isolate the target biologic from complex mixtures.
• Ion Exchange Chromatography : Separating molecules based on charge differences, optimizing purity and recovery of the target biologic.
• Size Exclusion Chromatography (SEC): Using size-based separation for final polishing steps, removing aggregates or fragments to ensure the target biologic's integrity.
• Hydrophic Interaction Chromatography (HIC): A powerful technique for purifying proteins based on hydrophobicity, ensuring high selectivity while preserving biological activity.
  
  

Filtration & Concentration

Our filtration strategies, including ultrafiltration and diafiltration, are designed to concentrate the target product and remove low molecular weight impurities. These steps play a vital role in improving the overall yield and purity of the product.

• Ultrafiltration: Concentrating the biologic product by removing water and smaller impurities, ensuring a high-quality concentrate.
• Diafiltration: Using buffer exchange to remove salts, small molecules, or other contaminants that may affect the final product's stability or activity.
  
  

Process Characterization & Optimization

Rodon employs a data-driven approach to characterize and optimize every step of the downstream process, ensuring maximum yield and purity while maintaining product quality. We continuously evaluate and adjust critical parameters, such as pH, temperature, and flow rates, to ensure consistency and reproducibility.

• Critical Process Parameter (CPP) Monitoring – Real-time monitoring of parameters like pH, conductivity, and protein concentration during purification steps.
• Yield and Purity Optimization – Ensuring that the highest possible yield and purity are achieved through extensive testing and process adjustments.
  
  

Tech Transfer & Scale-Up for Commercial Manufacturing

As part of our downstream processing services, Rodon provides comprehensive support for transferring purification processes from the laboratory to large-scale manufacturing. We ensure that the process is optimized for large-scale production, maintaining product quality, reproducibility, and scalability throughout the transfer.

• GMP Compliance – Ensuring all downstream processing steps are compliant with Good Manufacturing Practices (GMP), meeting the highest regulatory standards.
• Scale-Up Support – Seamlessly scaling up from small-scale to commercial production, ensuring that purification processes can be efficiently replicated in large bioreactor systems.
• Regulatory Documentation – Providing the necessary documentation for regulatory submissions, ensuring smooth filing and approval for clinical trials and commercial manufacturing.
  
  

Analytical Support for Downstream Processing

At Rodon, we provide comprehensive analytical support throughout the downstream processing pipeline, ensuring that the purified biologic meets all necessary quality and regulatory standards. Our analytical team uses a range of techniques to assess product purity, integrity, and functionality.

• Purity & Impurity Profiling – Comprehensive testing for host cell proteins, endotoxins, aggregates, and other impurities.
• Activity & Potency Testing – Ensuring that the biologic retains its intended activity and functionality after purification.
• Stability Studies – Conducting stability assessments to ensure that the purified product remains stable throughout its shelf life.

Partner with Rodon Biologics for tailored downstream processing that ensures efficiency, scalability, and cost-effectiveness. Let’s optimize your purification process and accelerate your path to success! Reach out to us today.