There are many challenges faced by biopharmaceutical start-ups in navigating through the discovery, development and commercialization pipeline that can be barriers to forward progress. Backed by years of expertise and a diverse portfolio of products and services to support these workflows, MilliporeSigma offers services that can help identify a path forward, no matter how complex the molecular journey. This is especially true for cell and gene therapy developers where a process template may not exist requiring you to draw your own path as you go, despite uncertainty and unique challenges, to meet the urgent needs of patients.

This video published by MilliporeSigma highlights the best practices for biopharmaceutical start-ups at every stage, from development to outsourcing and regulatory guidance.

Tools & Services

MilliporeSigma can help companies rise above the risks and accelerate drug development with tools for candidate discovery, preclinical to commercial manufacturing capabilities, testing services and opportunities for collaboration with industry experts to overcome many of the common hurdles experienced by startup companies. From their ADC Express™ services to comprehensive end-to-end solutions with the Bioreliance® program, MilliporeSigma provides the technology and knowledge resources to define a path to success for cell and gene therapy.

ADC Express™

Antibody-drug conjugation uses monoclonal antibodies or other biologics to selectively deliver highly active or potent pharmaceutical ingredients (HPAPIs) to targeted cells, which mitigates many of the off-target toxic effects to improve drug safety profiles. This technology is being leveraged by many biopharmaceutical companies to develop safer oncology and non-oncology drug products.

With more than 35 years of experience, MilliporeSigma utilizes established platform technology for the rapid development and manufacture of antibody-drug conjugates (ADCs) to enable candidate selection and subsequent development and commercialization strategies. The team of dedicated experts can provide process development, analytical development, testing and GMP complaint manufacturing support.

• • Random cysteine or lysine conjugation technology
  • Site directed conjugation via engineered mAbs or enzyme catalyzed
  • Non-natural amino acids (NAA)
  • Various payloads – auristatins, PBD, tubulysines, maytansiods and custom toxins

M Lab™ Collaboration Centers

The M Lab™ Collaboration Centers offer the opportunity and physical space for interdisciplinary collaboration with MilliporeSigma scientists and engineers as well as industry experts. Biopharmaceutical developers can explore ideas, learn innovative techniques, receive guidance for process development and scaling procedures and work together to overcome critical process development and production bottlenecks in their technologies. Located in life science hubs around the world, M Lab™ Collaboration Centers offer the flexibility to troubleshoot and test in their facilities outside of a developer’s own production space.

Bioreliance® End-to-End Solutions

BioReliance® End-to-End Solutions provides global support and expertise to accelerate clinical drug development encompassing cell line and process development solutions through facility design and construction to scale your technology for commercial success while at the same time reducing costs and mitigating risk.

• Biopharma Process Development
• Clinical Scale Template
• GMP Clinical Supply Solutions
• Facility Design and Construction
• Process Scale Up and Technical Transfer Services
• Project Management Expertise

MilliporeSigma’s dedicated, experienced team can help developers navigate the entire lifecycle of their therapeutic from end-to-end with worldwide access to high quality products and unparalleled service offerings.