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4955 Directors Place, Suite 300
San Diego, CA, 92121
United States

8582034200

The ADC Specialty Company

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Services


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Antibody Drug Conjugation

Antibody Drug Conjugation

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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cGMP Production

cGMP Production

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 Services

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