MilliporeSigma

Bring safe, life-changing medicines to market

Your partner for innovative biosafety testing and
product characterization

Expert biopharmaceutical testing services

BIORELIANCE® BIOSAFETY TESTING AND PRODUCT CHARACTERIZATION

Choosing the right partner for your analytical and biosafety testing is critical in the race to approval. Our BioReliance® testing services offer exceptional, risk-mitigating solutions with technical and regulatory expertise, to help you bring life-changing drugs to market. Our testing and manufacturing services span the product cycle from early pre-clinical development to licensed production. Partner with us to meet your needs for Biologics Safety Testing, Product Characterization, and Biomanufacturing Services.

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We've been shaping the industry for decades and are proud to be the first in the world to:

  • Develop polio vaccine biosafety protocols in 1955
  • Develop mouse antibody test in collaboration with the U.S. NIH in 1960
  • Develop the safety protocol for first gene therapy to enter human clinical trials in 1990
  • Characterize the first U.S. national stem cell banks in 2007

Ready to begin your project? Request additional information here.

Support for all phases of biopharmaceutical drug development

Whatever stage of the biopharma development process you’re in, our leading cGMP-compliant testing services and regulatory knowledge can help you progress your therapeutic from discovery to release.

This table represents the most likely timing for when a service will be needed during development.
*Product characterization methods
**Support for IND and BLA enabling studies
∆Including Next Generation Sequencing and the Blazar® platform for rapid methods

With comprehensive and integrated packages of services, we support your traditional and novel modality development:

mAbs (Monoclonal antibodies)

mAbs (Monoclonal antibodies)

mAbs are recombinant proteins produced using different expression systems. They contain one or more antigen-binding sides that bind to specific targets enabling diagnostic or therapeutic applications.

    ADCs (Antibody Drug Conjugates)

    A monoclonal antibody conjugated to a payload via a linker molecule.

      Viral and gene therapies

      Viral vectors for ex vivo modification of autologous and allogeneic cell therapies.

      Viral vectors for in vivo gene delivery (typically transgenes) or gene editing complex delivery.

      Oncolytic viruses with or without inserted genes typically for treatment of cancer.

        Cell therapies

        Modified or unmodified whole cells administered as therapeutic modality to replace or repair damaged tissue and/or cells. Cell therapies may be autologous if derived from the patient receiving the treatment, allogeneic if derived from donors other than the patient receiving them.

          Vector-based vaccines

          Modified version of an unrelated virus used to deliver and express gene sequence from a virus of concern specifically for use as a vaccine.

          Recombinant proteins produced via a viral vector in vitro, harvested and used as a vaccine.

            Nucleic acids/LNPs (Lipid Nanoparticles)

            Nucleotide-based therapies or vaccines (DNA or RNA), that are intended to modify gene expression, by promoting expression of desired genes, replacing genes, or inhibiting gene expression, and utilize non-viral delivery methods.

              Traditional vaccines

              Inactivated viral vaccines made from whole, killed virus or live attenuated vaccines containing genetically modified or naturally attenuated virus.

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                Related Services

                Characterization
                Explore our in-house services for product characterization, viral vector characterization, and cell line characterization. Partner with our experts to streamline your workflow.
                Testing
                We are a leading provider of contract services in the biopharmaceutical industry, supporting every phase of the testing, development and manufacturing process and offering a comprehensive and integrated package of services.
                Contract Manufacturing
                Reduce risk, remain compliant and accelerate development and manufacturing timelines by working with a single, trusted partner for all your API, mAbs, Viral Vecdtor & contract manufacturing needs.

                Related Applications

                Monoclonal Antibody Manufacturing
                Monoclonal antibody manufacturing is a highly templated approach used to produce mAb-based immunotherapies. Robust, scalable process solutions are required at every step to ensure high therapeutic concentration and process safety, while meeting speed-to-market and cost containment concerns.
                Gene Therapy Manufacturing
                Growing use of gene therapies is driving rapid innovation in an evolving global market. Manufacturers bringing new gene therapies to life face complex challenges, requiring an experienced partner capable of integrating vector manufacturing, testing, safety, process development, and regulatory compliance.
                Antibody-Drug Conjugate (ADC) Manufacturing
                Antibody-drug conjugation (ADC) technology uses monoclonal antibodies (mAbs) to deliver potent, highly active pharmaceutical ingredients (HPAPIs) to targeted cells. Learn about processes and areas of expertise required to advance your ADC to market.
                Cell Therapy Manufacturing
                Introducing a new cell therapy demands optimal performance in upstream and downstream processing, process development, testing, and manufacturing. World-class products and partners are critical to success, speeding advancement of therapeutics that are effective, safe, and affordable.
                Vaccine Manufacturing
                From early phase development, through downstream purification to large scale vaccine production: learn more about vaccine process development and application expertise.