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
• We specialize in formulation development and optimization, including pH and buffer screening, bulk agent and lyoprotectant selection, and surfactant screening.
• Our services include conducting forced degradation studies to identify degradation pathways.
• We develop and optimize lyophilization cycles, focusing on parameters such as freezing method, ramp rates, shelf temperatures, chamber pressure, and drying endpoint assessment.
• We conduct boundary condition studies on shelf temperature and chamber pressure to ensure preliminary robustness for lyophilization cycles.
• Our team supports scale-up manufacturing through effective technology transfer.
• We perform reconstitution volume studies to ensure appropriate drug concentration after reconstitution.
• We assess in-use compatibility and post-reconstitution stability to support clinical administration.
• Our formulation robustness studies and process characterization that adhere with QbD principles.
CDMO@hjbbio.com
