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BIB has expertise in helping clients tailor appropriate drug product presentations and dosage forms for the current stage of development. This can include simple frozen or lyophilized DP for early phase clinical trials, to high-concentration liquid biologics formulations for later phases, and finally to complex combination devices for eventual commercial DP. We work with you to realize your stage-appropriate Target Product Profile (TPP).

  • Develop-ability and preformulation assessments are carried out to understand the physicochemical properties of your biologic drug. Potential problems such as physical or chemical stability, high concentration viscosity, or surface adsorption propensity are identified and preliminary critical quality attributes (CQAs) are assigned.
  • Formulation screening of buffers, excipients, pH, salts, osmolytes, viscosity reducers, and surfactants via DOE studies are performed to identify optimal formulation conditions for solubility, stability, and viscosity. Techniques to determine protein-protein interactions are used.
  • Lyophilization cycle development is conducted if required based on molecule stability or client needs.
  • Formulation robustness studies in primary containers according to the current TPP (e.g., vials, syringes) are performed to provide ranges for manufacturing and for optimal stability.
  • DP process characterization and optimization studies are conducted for DS thawing, mixing, pooling, filtering, filling, and lyophilization to enable scale-up and tech transfer for clinical and commercial manufacturing.
  • Stability studies according to ICH guidelines, including long-term, accelerated, and stressed conditions, are conducted as part of formulation screening, robustness, and process optimization to ensure that the biologic critical quality attributes (CQA) remain in predefined ranges and to provide DP shelf-life guidance.
  • Conduct DP manufacturing process characterization per regulatory guidance (FMEA risk analysis and mitigation) to ensure process robustness and product quality.
  • Design and implement process validation and BLA enabling studies of DP manufacturing
  • Contributions to and writing of IND and BLA DP sections (3.2.P) are offered.
  • As part of DP life cycle management, simple drug product presentations and dosage forms such as liquid/lyophilized vials to more complex drug-device combination products, such as pre-filled syringes, autoinjectors, pens, and larger volume devices, are enabled.
  • In-use stability characterization is provided to determine if there are potential issues with DP handling, preparation, administration, and sterility at clinical sites.

cGMP DP MANUFACTURING AND QC SERVICES FOR BIOLOGICS

BIB has world-class DP manufacturing facilities for recombinant proteins, antibodies, and peptides. Our fill/finish capabilities include vial and syringe filling, and lyophilization of filled vials.
Zhangjiang site (P01)
Lingang site (IP02)
Lingang site (IP03)

Operation time Operating 2023 Q3 Liquid vial 90,000 pcs/hr
Max. batch size: 100,000 pcs
Lyophilization 7.5 m² lyophilization area
Max. batch size: 20,000pcs
Pre-filled syringe 1ml standard type and slim type, 1,800 pcs/hr (Including Cartridge)
Others Drug-device combination products Type of vials 2R/6R/8R/10R/14R/50R

BIB can conduct formal QC ICH condition stability studies to generate data for DP release and for assigning shelf-life.