Downstream Process Development (DSP)
ExcellGene is a Contract Development Manufacturing Organization company that offers you downstream process capacity up to 200 L scale for the production of biologics or novel biological entities (NBEs), focused on recombinant proteins. ExcellGene supports your downstream process development and material production from preclinical to clinical material. Further, ExcellGene offers you the optimization and characterization of your downstream process to support clinical or commercial development.
Here are some of the key features of ExcellGene’s downstream process:
- High purity: ExcellGene’s downstream process is designed to produce drug substances with high purity levels, which are required for pharmaceutical use.
- Scalability: The downstream process is scalable from lab-scale to commercial production, enabling clients to easily transition from research to manufacturing. ExcellGene offers technical transfer services to accompany you in your journey.
- Flexibility: The downstream process is adaptable to a variety of mammalian production systems, CHO and HEK cells.
- Speed: The downstream process is optimized for efficiency and robustness, designed with cutting-edge technologies, which means that proteins can be produced in a shorter amount of time than with traditional downstream processes (usually two chromatography steps instead of 3).
- Customization: ExcellGene’s downstream process can be tailored to the specific needs of each client, providing a customized solution that fit any particular requirement.
- Experience: ExcellGene has successfully developed downstream process for biosimilars and NBEs, collaborating with Big Pharma, mid-sized companies and startups worldwide.
- Quality control: ExcellGene’s downstream process includes rigorous quality practices and control measures to ensure that the final product meets the required specifications and is free from contaminants. ExcellGene’s downstream process services comply with ISO 9001.