Milliporesigma Brochures

  1. Product Characterization Assay Package - Interlot And Biosimilar Comparability 7/14/2019

    Monoclonal antibodies (mAbs) are highly complex biomolecules easily affected by changes in the biopharmaceutical manufacturing process. Something as simple as a temperature fluctuation can produce a change in higher order structure (HOS) that renders the mAb less active or inactive. Whether your mAb is an original product or a biosimilar, our comparability studies are designed to ensure robust and reproducible mAb production.

  2. Product Characterization Assay Package - Cell Line Development 7/14/2019

    Our Product Characterization services offering combines mAb physicochemical and structural information with the activity profile captured from binding, affinity, and potency bioassays to better understand the function of your drug—its critical quality attributes. All testing is performed in a GMP qualified laboratory and is compliant with ICH guidelines, FDA, and EMA regulations.

  3. Product Characterization Assay Package - Impurities 7/14/2019

    Many different impurities are present in or generated during the mAb manufacturing process. We work to make sure your biotherapy’s development program isn’t derailed by process or product contaminates that can arise from raw input materials, occur as residual processing agents, or formed as reaction by-products.

  4. Product Characterization Assay Package - Lot Release And Stability Testing 7/14/2019

    Before your mAb therapy reaches a patient, it is important to ensure product safety and efficacy. This includes understanding the effects of environmental conditions—temperature, humidity, light, container interactions—on your mAb. We offer a full portfolio of lot release and stability testing services performed to GMP guidelines.

  5. CHO Cell Culture Media And Feeds - Selection Guide

    Explore a range of off-the-shelf solutions created to support all your cell line development needs and CHO production processes.

  6. Gene Therapy Capabilities For AAV And Lentivirus Production

    Explore all of our gene therapy solutions for AAV and Lentivirus manufacturing based on 30+ years of experience to help bring your therapy to life. 

  7. Comprehensive Solutions For Your Vaccine Platforms

    Vaccine production, from process development to full-scale GMP-manufacturing, must be efficient, safe, and cost-effective. Learn how our global capabilities can help you achieve these goals for all your modalities/platforms.

  8. Roadmap To Success: Viral Clearance Services

    Accessibility and availability of viral clearance services are critical when it comes to on-time filing with regulators. Explore a solution that supports your clearance needs.

  9. Analytical Development And Characterization For AAV

    Our assay packages and phase-appropriate assay development and validation capabilities provide the product and process knowledge you need to develop a QTPP and identify the CQAs for your therapy.

  10. AAV Biosafety Testing & Characterization Services

    Biosafety testing and characterization for new products are essential as they emerge for clinical study. Both measures will help mitigate safety concerns and confirm product quality before these therapies are administered to patients. Our BioReliance® AAV testing services give you the confidence to get your products to market quickly and safely.