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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.

Cell therapy

Gene therapy

Visit our Cell and Gene Therapy Virtual Gallery for an interactive experience of our cell and gene therapy production solutions.

MILLIPORESIGMA PRODUCTS

For High AAV Titers Across Multiple HEK293 Cell Lines

The baculovirus-insect cell system is widely used for production of recombinant proteins and clinical stage AAV due to its flexibility, speed, simplicity, and productivity.

The Sf-RVN® Insect Cell Line is a rhabdovirus-negative Sf9 cell line that can be grown in both adherent and suspension culture. Sf-RVN® Insect Cell Line has been adapted for growth in a chemically defined medium to be used for the production of recombinant proteins, adeno-associated viruses (AAV) and viral-like particles (VLP). The EX-CELL® CD Insect Cell Medium, recommended for use, is optimized to get excellent growth and productivity of the Sf-RVN® Insect Cell Line. Combined, these two products form the Sf-RVN® Platform to help improve the safety profile of your gene therapy.

You’re developing lifesaving gene therapies and need to manufacture AAV vector as quickly as possible. But scale-up and regulatory hurdles make the path to the clinic slow and labor intensive. We’re here to help.

The VirusExpress™ 293 AAV Production Platform offers a transfection-based solution using a suspension-adapted cell line, which is GMP banked and characterized, chemically defined medium, and a process with proven performance at clinically relevant scale.

CellPrime® rAlbumin is expressed in Pichia pastoris from a gene construct that encodes a non-glycosylated human albumin.

In recent years, the development of media used to expand and mature adult stem cells has greatly increased the success rate of adult stem cell therapy and the breadth of potential stem cell-based therapies. To obtain enough cells, ex vivo expansion has been utilized to ensure successful engraftment and economize the manufacture of both allogeneic and autologous therapies.

You’ve developed your viral vector gene therapy and now it’s time to embark on the voyage to manufacturing. But gene therapy production is uncharted territory, and you need someone to help navigate through the process. We can help.

You’re developing lifesaving gene-modified cell therapies and need to manufacture lentiviral vector as quickly as possible. But scale-up and regulatory hurdles make the path to the clinic slow and labor intensive.

We're here to help.

For single-use per batch biomolecule purification

A high capacity, high throughput strong anion exchange chromatography membrane designed for single-use per batch biomolecule purification. The unique Natrix® Q membrane contains a high density of quaternary amine ligands that are directly polymerized within the porous membrane scaffold.

Benzonase® endonuclease — the smart solution for DNA removal in biopharmaceutical production.

From your bioreactor to final sterile filtration, the new NovaSeptum® GO sampling system lets you sample processes the way you want. Flexible formats and volumes adapt to your process for robust, reliable monitoring and quality assurance.

MilliporeSigma’s Mobius® single-use mixing solutions deliver advanced technology for mixing pharmaceutical ingredients from intermediate to final drug products and for the preparation of process solutions, such as buffers and media. Unlike traditional stainless-steel mixers, single-use mixers reduce downtime due to CIP, SIP, cleaning validation, and process engineering. Mobius® single-use mixing solutions also offer operational flexibility as they can be up and running in less than five minutes. They are capable of mixing speeds up to 1000 RPMs meeting the broadest range of mixing production requirements. Mobius® flexibility offers you a choice of just the right filter, connector, tubing options for your specific application and environment, including sterile interfaces, from fermentation to final fill. Sizes range from 10 L to 3000 L.

CONTACT INFORMATION

MilliporeSigma

400 Summit Drive

Burlington, MA 01803

UNITED STATES

Phone: 1-800-645-5476

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