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

8582034200

The ADC Specialty Company

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Levena Biopharma

 

The ADC Specialty Company

Our mission is to provide our clients impeccable service, technologies and superior quality for the discovery and development of new antibody drug conjugates. Creating the best solutions for cancer and other unmet medical needs is our highest priority for patients worldwide.

Levana Biopharma has built a one-stop-shop for ADCs from inception to clinic and beyond. Over the past 9 years we have developed a full suite of reagents, tools and capabilities to enable our clients and partners with the opportunity to produce best in class antibody drug conjugates.

 
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Levena Biopharma’s linkers embody a wide range of structures and functionalities, designed for the conjugation of a broad spectrum of antibodies and toxins. More importantly, our linkers allow the conjugation process to be performed in a precise and controlled fashion, easing the batch-to-batch product manufacturing and quality control. We use conventional chemistries to provide customized design and synthesis of linkers to support your drug development.

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Levena Biopharma offers a comprehensive assortment of tubulin inhibitors and DNA-alkylating agents that are proven and used commercially as payloads. These toxins listed below are available in purity that is suitable for use as an API; we also can provide cGMP production of 100 gram quantities. Levena Biopharma in addition has a portfolio of proprietary toxins available for testing and licensing upon request.

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Levena Biopharma offers Safe & Easy Toxin (SET™), a intuitive research tool for rapid antibody-drug conjugation experiments. SET™s ready to use to validated linker-toxins in small, pre-packaged vials equipped with septum. Each SET™ vial contains approximately 200nmol of linker-toxin, sufficient to conjugate up to 5mg antibody with a drug-to-antibody ratio (DAR) of 3-4. No weighing or aliquoting of the linker-toxin is necessary. Simply follow the dissolution protocol provided with the product and the SET™ is ready to use. The SET™ format is easy to use and, at the same time, minimizes the exposure of the lab space to hazardous toxins. 

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Levena Biopharma has developed pre-screening kits using Protein A and Protein G, PSKA™ and PSKG™, that can expedite the identification of antibodies suitable for ADC candidates. With these kits, primary antibodies can be screened without individual conjugation to cytotoxic agents. We offer PSKs with widely-used industry standard toxins such as MMAE, MMAF, DM1, and duocarmycin.

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Levena Biopharma offers a set antibodies against a variety of payloads. Currently, the following anti-toxin (drug) monoclonal and polyclonal antibodies with specificity against different categories of cytotoxic drugs.  These products are for research purposes only, not for use in diagnostics. 

  • MMAE/MMAF
  • DM1/DM4
  • Calicheamicin
  • Duocarmycin
  • PNU
  • Amanitin
  • PBD 

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Antibody Drug Conjugation

Levena Biopharma has a veteran team of scientists to provides small,  large scale proof-of-conceptas 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.

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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 invite to visit and audit. 

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Analytical Services

We offer a wide range of analytical services such as 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.  We also have CMC development and technical transfer capabilities.

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