Comprehensive solutions for your ADC – collaboration with Baxter BioPharma Solutions

SAFC and Baxter’s BioPharma Solutions business (BPS), two of the industry leading contract manufacturing organizations (CMOs) in the Antibody-Drug Conjugate (ADC) space, are offering a combined approach for your ADC to simplify the supply chain and provide comprehensive, coordinated and collaborative services for the development, manufacturing, and testing of bulk drug substance (BDS) and drug product (DP).

Quality and experience

Antibody-Drug conjugates (ADCs)

Antibody-drug conjugation technology uses monoclonal antibodies or other biologics to deliver conjugated Highly Active-Pharmaceutical Ingredients (HAPIs) to targeted cells. In conjugated form, the HAPI exhibits more selective cytotoxicity, thereby, sparing nontarget cells from many of the toxic effects.

Why choose SAFC and Baxter

  • Streamlined support, with dedicated project managers at each site working closely together to help ensure a consolidated timeline and a transparent transfer, allowing you to focus on your discovery and development for the next programs in your pipeline
  • Supply chain consolidation that gives you comprehensive ADC services under one “virtual roof”
  • Reliable experienced partners with proven track records, able to deliver your product and meet your timelines with high quality and on budget

ADC Services

  • Conjugation
  • Linkers and cytotoxic agents
  • Formulation development
  • Fill/finish including lyophilization
  • Process development
  • Technology transfer
  • Analytical method development and validation
  • Stability studies for BDS and DP

Complete support for your ADC

SAFC and BPS have hands-on experience with more than 20 different ADC constructs. A seamless transition between the manufacturing of your BDS and your DP – one less step for you to coordinate on your path to the clinic and commercialization.

Two (2) Global leaders

Broad range of solutions

Together we offer a full range of services needed for ADCs.

  • Process development, technology transfer, linkers/cytotoxic agents, conjugation, testing and stability studies by SAFC
  • Formulation development, technology transfer, fill/finish including lyophilization, and testing by BPS

Logistics streamlined globally

With decades of experience in shipping products around the globe, SAFC and BPS will coordinate the necessary import/export requirements, documentation, and product handling between development/manufacturing sites, allowing you to focus on drug discovery.

Quality and experience

SAFC and BPS have experience with a variety of antibodies, chemistries and cytotoxic agents. Whether it is a well established licensed payload, or a novel, highly potent toxin, you can be confident it will be handled safely with appropriate containment and personnel training.

SAFEBRIDGE® Certification

  • SAFC: The conjugation site has been SafeBridge Certified since 2009 and the site manufacturing cytotoxic agents and drug linkers since 2003
  • BPS: The only company worldwide with facilities certified by SafeBridge doing both parenteral drug substance synthesis and parenteral drug product manufacturing and testing
  • Both companies have dedicated facilities that are SafeBridge Certified to handle Category 4 compounds

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