HJB - Your Trusted Biologics CDMO Partner

HJB, CDMO, biologics, HJB Bio, hjbbio, China CDMO, 杭州奕安济世, Just Bio, Just biotherapeutics, HJB bio, HJB China, Hangzhou HJB

HJB - Your Trusted Biologics CDMO Partner

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Upstream Process Development

We have developed a robust and high-quality Upstream process for production of any protein therapeutics. We use highly productive and scalable fed-batch (FB), intensified FB (IFB), and continuous perfusion (CP) platforms to ensure speedy process lock. Upon process lock, the process is scalable to pilot run (up to 200L) or to GMP manufacturing.

Upstream Process Development Platform Has the Following Features

  • Experienced: We are highly experienced in developing upstream processes for monoclonal, multi-specific antibodies, and other recombinant proteins. We have enriched experience in regulatory approval for process change from FB to IFB or from FB to perfusion while maintaining product comparability. Our well-known expertise includes media development, process development/optimization and process characterization.

  • Fast: Based on our platforms and deep knowledge in the FB, IFB and CP processes, typically, we can establish a robust and high-quality upstream process within 10 weeks from receiving top clones. We can complete process characterization within 6 months.

  • High Productivity: Based on average of actual projects we worked on, our FB process titers are ranged 3.3 ~ 9.9 g/L. Our IFB process output can improve 2X compared to FB process. Our CP process output can improve 10X compared to FB process, volumetric product rate (VPR) can be as high as 8 g/L-day.

  • Good Product Quality: Our perfusion process can remove metabolic byproducts, continuously replenish fresh media, maintain “steady state” environment, and continuously harvest product in real time. Due to above features, product quality is good and stable using perfusion process. In addition, perfusion process is especially suitable for some unstable proteins such as BsAb.

Upstream Early Phase Development Process

Services

• Stable pool material generation

• Media development and optimization

• FB, IFB, CP early phase process development

• Technology transfer & process scale-up

• Commercial process optimization & characterization

Equipment

WAVE Bioreactor

Bench-top Bioreactor

Xcell Lab ATF2

200L Single-Use Bioreactor

Cedex Biochemical Analyzer

SERVICES