Drug Substance Manufacturing
GMP & Non-GMP Drug Substance Manufacturing for Biologics
With advanced capabilities in both GMP and non-GMP manufacturing, our customized drug substance (DS) services are designed to meet the unique requirements of biologics programs worldwide, supporting projects from early development to commercial supply. We support a wide range of biologics, including monoclonal antibodies, bi-specific and multi-specific antibodies, fusion proteins, and other recombinant therapeutic proteins.
Capabilities
Flexible and Scalable Manufacturing
- Our manufacturing services support biologics programs from early-phase clinical trials to market-ready production. With flexible scales and independent suites equipped with single-use bioreactor technology, we ensure scalability and adaptability to meet each client’s needs.
- This flexibility allows for seamless progression from lab to pilot scale, enabling efficient technology transfer, engineering runs, and toxicology lot production, all while maintaining consistency and accelerating the path to market.
Upstream Processing
- Our upstream capabilities encompass cell banking (MCB and WCB), advanced single-use bioreactors ranging from 200L to 4000L, and efficient production processes to support biologics manufacturing at various scales, from early development to commercial production.
- From bioreactor operations to cell harvesting, we ensure cell cultures’ smooth and effective transition to downstream purification, maintaining optimal performance and product integrity.
Downstream Processing
- Platform Filtration and Chromatography Processes: Our downstream process includes multi-column chromatography for product capture and polishing, viral inactivation, and viral filtration. IPCs (in-process control) are implemented in each process step, ensuring the product quality and biosafety of the drug substance.
- Advanced Chromatography and Ultrafiltration/Diafiltration (UF/DF) Equipment: This equipment is designed for high-efficiency purification with a titer range from 2-10 g/L, ensuring batch consistency and optimal product quality. The fully automated state-of-the-art Cytiva chromatography and TFF systems ensure robust and consistent process performance and compliance with data integrity standards.
- Final Drug Substance Processing: Our advanced downstream process can produce final drug substances in high-concentration liquid formulations tailored for applications such as subcutaneous (SC) injection.
Advanced Technology and Innovation
In-Line Processing for Consistency and Quality
- Pharmaron’s in-line conditioning (IC) system improves efficiency during buffer preparation, pH adjustment, and conductivity monitoring. This innovative technology ensures batch consistency and supports the seamless transition from pilot-scale to market-ready manufacturing.
Upstream and Downstream Innovation
- Our state-of-the-art Axichrom Chromatography Systems and continuous centrifugation processes ensure high-quality purification and virus filtration, which are critical to achieving consistent and safe drug substances for biologics.
Contact Pharmaron for GMP and non-GMP Drug Substance Manufacturing
Explore Pharmaron’s biologics GMP and non-GMP drug substance manufacturing capabilities. Contact us today to discover how our services can accelerate your program from development to readiness for market.
