Need manufacture of a clinical stage or marketed ADC?
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Our full service offering for bioconjugate manufacture provides you with a tailored approach from drug intermediate manufacturing through drug substance manufacturing, all under one quality system supported by global regulatory services. We currently produce the majority of commercialized ADCs at our site in Visp, Switzerland, supplying more than 60 countries globally including Japan.

Our capabilities and services for Drug Substance Bioconjugate Manufacturing include:

  • cGMP facilities with safety procedures in place to handle cytotoxic compounds with OEL down to 1 ng/m3
  • Small scale conjugation facility: 50 –1,000 g scale
  • Large scale conjugation facility: 0.5 –5.0 kg scale
  • Qualified stainless steel and single-use equipment
  • Aseptic biopharmaceutical manufacturing environment

Our scientists and engineers bring years of development experience across a broad spectrum of both platform and novel conjugation technologies. Our services are geared to enable the commercialization of your drug candidate and we have a successful track record of process design and execution of validation/conformance batches to support PAI, launch, and commercial manufacturing requirements.

Engineering and manufacture of second generation ADCs can be complex.

View Our Webinar

Webinar highlight the use of our new Site Specific Conjugation (SSC) vectors designed for use with our proprietary GS Xceed® system. We outline a project plan for taking an antibody with engineered cysteines to a second-generation ADC. Finally, we’ll provide insight on how to successfully make ADC processes fit for production and scale-up based on our extensive ADC development and manufacture expertise.

We offer an end-to-end bioconjugate supply chain


"End-to-end" bioconjugate supply chain


Technology Capability
Antibody or other recombinant protein Protein engineering, humanization, immunogenicity, manufacturing assessment, LightPath™ discovery (non-GMP protein expression using GS System® vectors) Cell line or bank engineering (incl. expression vectors for site selective conjugation), cell line development, banking and stability. LightPath™ development Process transfer, optimization, characterization / qualification / validation and viral clearance, Pilot scale manufacturing Analytical method development / optimization and qualification / validation in support of BLA including ELISA and bioassay. Reference standard characterization and product stability studies Formulation development, stress and stability studies cGMP clinical and commercial manufacturing, release testing and regulatory services
Payload Develop or transfer semi-synthetic / synthetic process Broad chemistry toolbox and manufacturing network Process characterization / qualification / validation studies Analytical method development / optimization and qualification / validation in support of BLA Stress and stability studies cGMP clinical and commercial manufacturing, release testing and regulatory services
Drug Substance Sample preparation for stochastic and site-directed conjugation Cell line or bank engineering (incl. expression vectors for site selective conjugation), cell line development, banking and stability. LightPath™ development Process development / optimization for platform and novel conjugation technology Process characterization / qualification / validation studies Analytical method development / optimization / qualification / validation in support of BLA including execution of ELISA and bioassay cGMP clinical and commercial manufacturing, release testing and regulatory services
Drug Product Early and late stage formulation development (liquid and/or lyophilized) Drug product design Stability testing in representative container closure system Simulated administration studies, dosing administration instructions Manufacturing process transfer / setup and characterization cGMP clinical and commercial manufacturing at partner site and release testing at Lonza, Regulatory services

Technologies and products


Our GS Xceed® Expression System has options to engineer and express conjugation-competent antibodies. Applications include antibody drug conjugates (ADCs), half-life extension and imaging.

Unlike other contract development and manufacturing organizations (CDMOs), we are in the unique position to offer complete development and manufacturing services from both mammalian cell culture and advanced chemical synthesis for the production of Antibody Drug Conjugates (ADCs). From process development to manufacturing scale-up, we are proud to offer integrated services tailored to your drug and designed to reduce program complexity and timelines.

technology
GS Xceed® Expression System
Our GS Xceed® Expression System is a robust, fully integrated, scalable mammalian expression platform for producing recombinant therapeutic proteins. Our extensive technical expertise and advanced manufacturing services provide the confidence you need to ...
technology
Chemical Synthesis Technologies
We master an extensive array of chemical platforms and technologies.