Levena Biopharma has a veteran team of scientists to provides small, large scale proof-of-concepts well as PR&D support for ADC conjugation with a rapid turnaround. Our conjugation service delivers affordable and high quality custom ADCs, using combinations of payloads, linkers, and conjugation methods. Service includes a comprehensive ADC report with full characterizing specifications. We have prepared several hundreds of ADCs from human, mouse, and rat IgG1 and IgG2 from 1 mg to 200 mg. The ADCs have been used for in vitro, in vivo and clinical studies.

• Expertise in Seattle Genetics conjugation
  • cysteine-based
• Expertise in Immunogen conjugation
  • lysine-based
• Complete ADC characterization methods:
  • Advanced analytical tools: HPLC (HIC, SEC, RP), iCIEF, LC-MS
  • Quality: Drug-to-Antibody Ratio (DAR), purity via SDS-PAGE, aggregation, endotoxin, residual drug
  • In vitro pharmacology: over 100 common tumor cell lines (Including NCI-60 panel) for cytotoxicity studies.
  • Industry ADC reference standards are available for characterization comparison
  • Analytical method development and stability studies
  • Scale up and Process Development services up to commercial quantities

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Levena Biopharma has established a new process development and manufacturing capabilities in Suzhou to meet the need our growing customer base.  This modern facility is designed to accommodate up to kilogram-scale production and is compliant with the most stringent occupational safety requirements. You are cordially invited to visit and audit.

ADC payload/linker conjugation preparation

• Custom designed isolator (2) to handle potent API with SafeBridge category 4
• 4 separate HVAC systems with single passage air system and filters
• Synthesis and conjugation cGMP areas with clean room (class D and C)
  • GLP labs available to PR&D
• Purification capability including both normal phase and reverse phase
• Full analytical support (HPLC, K-F, UV, IR, NMR, MS)
• Conjugation instruments: AKTA PILOT, Milipore UF/DF

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Analytical techniques

• Method development
• Concentration determination with UV
• Drug-to-Antibody Ratio (DAR) and unconjugated antibody by HIC-HPLC
• Aggregate analysis by SEC-HPLC
• Residual drug composition by RP-HPLC
• Endotoxin
• SDS PAGE
• Cell killing assays
• ELISA
• Stability studies

CMC Development Capabilities

Process, Formulation, Analytical Development

• Development of conjugation processes for robustness, reproducibility and scalability
• Development of purification technologies (TFF and chromatography)
• Development of pre-formulation using DOE
• Development of analytical techniques for physico-chemical characterization

Technical Transfer Capabilities

• Technical batch sizes to 3g
• Development lab set-up for low bioburden/endotoxin manufacturing
• Process equipment design for scale up

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