领康时代 | 生物制品端到端一站式CDMO服务

Support Whole Lifecycle of Drug Products

mAbs, bsABs, ADC,
Protein-based vaccines

Lyophilization

Mixing

Filter selection and filtration process

Polit Scale Manufacturing
PFS:1-3ml
Liquid Vials:2-20ml
Lyophilization Vials:2-20R

Differences and risk assessment

Tech Transfer protocol and report

Formulation optimization

Lyophilization, mixing, filtration process optimization

Lyophilization process characterization

Formulation robustness

Mixing, filtration process characterization

Process change

Packaging form change

Strength change

Formulation Development

Support the formulation development for various types of biological products, such as antibodies, ADCs, recombinant protein vaccines, etc. By analyzing the data from developability assessment, the issue of product instability can be addressed during the formulation development.

mAb/BsAb/ADC: Stable liquid / lyophilized formulation
Recombinant protein vaccines: Vaccine formulation development with aluminum-salt adjuvant, MF59, AS03, CpG etc.

Drug Product Process Development

Development of freeze-drying process
Development of mixing process
Development of aseptic filtration process

Clinical Manufacturing

Provide non-GMP&GMP drug product production service.

PFS Line

Vacuum plugging Nitrogen protection (optional) Filling accuracy ± 3%

PFS 1400 syringes/h

Cartridge 1400 syringes/h

Vial Line

Vial washing, drying, filling, and capping combined production line 2m²Freeze Dryer Filling accuracy ± 3%

Lyophilized powder 2R: 8000 vials/batch 10R: 3800 vials/batch 20R: 1800 vials/batch

Liquid 2R: 3000 vials/h 10R: 2400 vials/h 20R: 2400 vials/h

Technology Transfer and optimization

Provide regulatory, document support, and process optimization service during product technology transfer.

Differences and risk assessment

Tech Transfer protocol and report

Process control strategy

Formulation optimization

Lyophilization, mixing, filtration process optimization and scale-up

Process Characterization

Following the QbD concept, we analyze the various process parameters of the DP process through risk assessment, experimental design, and data analysis to provide a robust design space for the process output.

Freeze-thaw Process Characterization

Mixing Process Characterization

Formulation Robustness Study

Filtration Process Characterization

Freeze-Drying Process Characterization

Post-Approval Change

Provide technical support and registration support for post-approval changes.

Process change

Packaging form change

Strength change

Main Equipment