
ABOUT MILLIPORESIGMA
Cell and gene therapies hold the promise to change lives. Even as the path to patients accelerates, manufacturing and regulatory complexity remains a challenge. With limited process templates, evolving regulatory guidance, and urgent patient needs, finding a partner with experience is critical to your success.
From solving your unique upstream and downstream challenges, to meeting urgent manufacturing timelines, and navigating uncertain regulatory guidelines, a knowledgeable partner can help move your cell and gene therapy from hype to hope.
At MilliporeSigma, we’re giving shape to cell and gene therapy development every day. We bring 30+ years of expertise, and a global organization to integrate leading manufacturing technologies with process development, scale-up, safety testing, and the regulatory experience to meet your therapy’s needs.
We have more experience in this area than almost anyone else in the industry. We were the first gene therapy CDMO to produce commercial product following successful regulatory inspection. Our products and services include optimized manufacturing platforms, media and reagents; manufacturing, biosafety and characterization testing, as well as process development services.
Draw on our experience to bring your cell and gene therapies to life.
Visit our Cell and Gene Therapy Virtual Gallery for an interactive experience of our cell and gene therapy production solutions.
CONTACT INFORMATION
MilliporeSigma
400 Summit Drive
Burlington, MA 01803
UNITED STATES
Phone: 1-800-645-5476
FEATURED PRODUCTS
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The use of Benzonase® endonuclease additionally increases the yield in virus purification, protects the downstream chromatography and filter devices from fouling and reduces feed stream viscosity. In this document we will provide you guidance on how to plan and set up a Design of Experiments (DoE) optimization experiment of Benzonase® endonuclease in your viral gene therapy process.
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Benzonase® endonuclease—the smart solution for DNA removal in biopharmaceutical production has proven its value for over 30 years. This bulletin explains a thorough analysis by our technical and regulatory experts that allowed us to come to the conclusion that Benzonase® endonuclease Emprove® Expert and Benzonase® endonuclease Safety Plus Emprove® Expert can be considered equivalent.
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Benzonase® endonuclease — the smart solution for DNA removal in biopharmaceutical production.
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With its new features, Benzonase ® endonuclease Safety Plus Emprove® Expert is ideally suited for manufacturing of cell and gene therapy agents such as adeno associated and lenti viruses, oncolytic viruses, and viral vector vaccines.
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Benzonase® endonuclease — the smart solution for DNA removal in biopharmaceutical production.
FEATURED ARTICLES
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The goal of clarification is to prepare the cell culture feed stream for downstream chromatography and purification. In this poster, we explore data driven strategies for clarifying harvest feed streams.
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In vaccine and viral vector production, impurity clearance is an essential purification step and required for drug approval as residual impurities may impact patient safety. A critical step in the purification process is reduction in the size and quantity of extracellular nucleic acids by endonuclease enzymes. This application note summarizes the benefits of incorporating Benzonase® endonuclease in a polio virus type 3 production process.
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Benzonase® endonuclease is a high-quality product delivering immense value to viral vector processes. The enzyme activity is strongly influenced by the matrix, and optimization of its use should be a mandatory step in process development. In this application note, we highlight an optimization strategy and process economics of DNA digestion in viral vector purification.
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This article demonstrates that depth filters clarify AAV vectors, helping to overcome the unique separation challenges presented by these important vectors for gene therapy.
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A number of risk mitigation strategies related to the materials used to produce viral vectors can be employed to help accelerate progress towards commercialization of remarkable therapeutics.