Process Development Solutions
Comprehensive Upstream and Downstream Processing for Biopharmaceuticals
Pharmaron offers comprehensive process development services tailored specifically for biologics, supporting each phase of your therapeutic development journey. From cell line development to drug product formulation, our end-to-end solutions ensure your biologics program progresses efficiently from research to market. We specialize in monoclonal antibodies, recombinant proteins, and other biologics, delivering scalable, GMP-compliant processes to ensure your products meet the highest quality, safety, and regulatory approval standards.
Our upstream and downstream process development capabilities are designed to optimize production yields, streamline workflows, and minimize costs while adhering to stringent global regulatory guidelines. By leveraging advanced bioprocessing technologies, we ensure seamless transitions from early-stage development to commercial manufacturing, reducing risks and accelerating time-to-market.
Capabilities
Upstream Process Development
Upstream process development focuses on optimizing biologics production with scalable, phase-appropriate processes from small-scale to commercial manufacturing.
- End-to-end upstream process development focusing on high productivity, quality, scalability, and reproducibility
- Culture media and feed screening to optimize cell growth for biologics production and quality
- Feeding strategy development for enhanced nutrient delivery and metabolic requirement
- Process parameter optimization to fine-tune production and ensure consistency
- Process lock and confirmation in bioreactors ranging from 15 – 50L
- Process scale-up up to 200L for toxicology lot production
- Late-phase process characterization to ensure regulatory readiness and smooth tech transfer to manufacturing
- Fed-batch and N-1 concentrated fed-batch processes for optimized production, with perfusion systems available
Downstream Process Development
Downstream process development ensures the purification and quality of biologics meets the highest standards for clinical and commercial use.
- Cell culture harvest and clarification for efficient biomass recovery
- Platform technology for mAbs and Fc fusion proteins to streamline production
- Customized purification processes for recombinant proteins and bi/multi-specific antibodies
- Resin screening and optimization for enhanced separation and purification
- Chromatography process parameter screening and optimization to achieve high-purity products
- Viral clearance studies to ensure product safety and regulatory compliance
- Ultrafiltration (UF)/Diafiltration (DF) for concentration and buffer exchange
- High-throughput process development using purification for process optimization
- Late-phase process characterization to ensure regulatory readiness and smooth tech transfer to manufacturing
Ready to Scale Your Biologics Production?
Partner with our experts to accelerate your biologics development. Learn how our tailored solutions can optimize every stage of your process, from formulation to final product. Contact us today to discuss how we can support your project.
