中文From Monoclonal Antibodies to Polyclonal Antibodies: Establish Highly Consistent and Scalable Antibody Process Platforms
Antibody therapeutics are continuously evolving toward diversification and higher complexity. Monoclonal antibodies, bispecific antibodies with complementary functions, and trispecific antibodies targeting multiple regulatory sites all impose more stringent requirements on expression systems, cultivation strategies, and process stability.
Lepure Biotech‘s leverages robust platform capabilities and comprehensive qualification systems to develop highly modular platform architectures, enabling rapid development, scalable manufacturing with high safety, and consistent commercial supply for various antibody modalities.
R&D & Cell Line Construction
Lepure Biotech provides comprehensive support at the initiation stage of antibody development. Spanning cell line development, culture medium optimization and lab-scale process exploration, we help customers rapidly establish robust manufacturing systems.
- CHO-K1Q Cell Line — High Productivity & Excellent Stability
- CHO Culture Media — Meet cell growth and titer requirements across all process stages
- LePhinix™ EZG Benchtop Bioreactor — Versatile for research development and scale-up verification
- Microcarriers — Spherical & Flake Microcarriers to Improve Adherent Cell Culture Efficiency
Upstream Processing
During process scale-up and commercial production phases, Lepure Biotech delivers solutions compatible with multiple cultivation modes to ensure stable and efficient cell growth.
- LePhinix™ Single-Use Bioreactor— Compatible with batch, fed-batch, perfusion and other cultivation modes
- LeCouple™ Sampling System
Filtration & Purification
Lepure Biotech delivers high-purity, high-recovery solutions for filtration processes to guarantee consistent quality of antibody pharmaceutical products.
Downstream Formulation & Large-Scale Manufacturing
For formulation preparation and large-scale production, Lepure Bio focuses on single-use solutions to provide customers with safe and flexible operational support：
- Filling Bags — Meet requirements for sterile and precise liquid filling
- Soft Isolators — Create a controlled environment to mitigate contamination risks
- Accessory Consumables including Single-Use Gloves — Ensure convenient and safe production operations
Intermediate & Buffer Preparation
Throughout antibody drug manufacturing, Lepure Bio offers comprehensive single-use solutions for intermediate processing and buffer preparation to deliver efficient, secure and regulatory-compliant operations:
- Mixing Bags & Magnetic Stirring Systems— Enable rapid homogenization and batch preparation of buffer solutions and intermediate liquids
- LeUnipore™ PES / Extreme™ PVDF Products— Deliver high-throughput filtration with low adsorption characteristics
- Single-Use Tubing & Connectors— Facilitate end-to-end sterile transfer and flexible fluid line interconnections
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