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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

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.

The ekko™ Cell Processing System is a true fit-for-purpose cell therapy manufacturing solution, employing acoustic technology and a multi-use platform to simplify cell therapy manufacturing. Its modular design improves flexibility and utilization while imparting minimal energy and stress for gentle handling of cells.

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.

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

FEATURED ARTICLES

  • With a diverse landscape of potential partners, it is important to know what qualities to look for in a technology provider and how to traverse the challenges inherent in managing multiple relationships.

  • There is no one-size-fits-all model for AAV gene therapy products when it comes to viral clearance studies. Here we address some of the questions with respect to viral clearance studies for AAV vectors.

  • Because viral safety is essential in the manufacture of biopharmaceuticals, we developed a proven Sf9-rhabdovirus-negative insect cell line that improves the safety profile of our customers’ bioprocesses.

  • It is critical to vet not just the expertise available at a CDMO, but also the effectiveness of their facility design to reduce risk and meet scale-up needs.

  • By unlocking the value of an integrated solutions provider, you can leverage a comprehensive suite of advanced technologies and expertise that will facilitate your path to market and benefit you for the lifetime of your product.

  • Review the development of a suspension based AAV upstream production process that provides a more efficient and cost-effective bioprocessing solution for large scale production.

  • This poster reviews two virus-based gene delivery platforms – adeno-associated virus (AAV) and lentivirus (LV) – focusing on the development, validation, and implementation of titration methods used to measure functional titer.

  • MilliporeSigma’s new cell culture medium offers an improved alternative to classical formulations that can help address the constraints in viral vector manufacturing and scale-up.

  • A guide to plasmid DNA downstream process development including clarification, TFF, chromatography, and sterile filtration unit operations.

  • Mirror mirror on the wall, what is the promise that Gene Therapy holds for all? The urgency, uniqueness, and uncertainty surrounding gene therapy manufacturing creates many challenges. Let us take a look into the crystal ball of gene therapy to address unanswered questions and plan for what’s next in 2021 and beyond.

  • In this podcast, Ratish Krishnan, Associate Director for Cell & Gene Therapy talks about the tremendous promise gene therapies have for changing the healthcare paradigm and solutions to some of the biggest challenges in gene therapy manufacturing.

  • With more gene therapy manufacturers needing to increase their batch size and efficiency, it’s necessary to invest in a viral vector manufacturing system that can be scaled up to meet commercial demand. In this infographic, learn how suspension systems offer many benefits that will help viral gene therapy developers enhance their processes and capabilities to better meet patient demands.

  • With more and more organizations looking to pursue gene therapies for a range of indications, there remain a number of barriers to entry. However, the next decade will bring improvements across existing gene therapy modalities, including the development of alternative approaches to gene delivery, and advances in upstream and downstream processing, analytical methods and intensified/continuous processing.

  • With continuously evolving gene therapy regulations and guidance and limited time during development for testing, here are four points to consider when planning product-release testing of your gene therapy product.

  • This eBook describes automation of continued process verification and offers a one-click solution for statistical trending of data, campaign reports, and annual product quality review.

  • The rapid success of gene therapies also brings with it a number of challenges, the most significant being ensuring a sufficient viral vector supply, despite shortened development timelines. This infographic demonstrates how cells grown in suspension are much better suited for large-scale production of viral vectors, what to consider in order to successfully scale-up your viral vector production, including the challenges faced in upstream upscaling, and a specific solution we’ve developed to help you address these challenges.

  • Although suppliers have proven themselves rather robust in their dealing with the pandemic and business is continuing generally uninterrupted, there will be significant long-term changes.

  • We interviewed major biopharmaceutical industry senior bioprocessing decision-makers, and bioprocessing suppliers in the US and Europe. The impact on emerging biopharma companies as well as smaller suppliers may actually be a small silver-lining for some, during this global, horrific event.

  • Because of the urgent demand for treatments, vaccines and assays, the pharmaceutical and biotech industries are experiencing disruptive, often chaotic, increased demands on resources. 

  • Following successful Industry 4.0 implementation in the automotive, communications, aerospace, and other industries, the biopharma industry is now joining the digital revolution.

  • This article explains the 4 Cs of Biopharma 4.0 - the software, automation and analytics tools that allow Control of unit operations, Connection across the process, Collection of data, and Collaboration such as remote support and cloud services.

  • Process development is a crucial step in viral vector manufacturing and a successful CDMO partnership can help navigate the challenges associated with scaling your viral vector. This infographic outlines the history of gene therapy and presents critical factors that need to be taken into consideration for a successful path to commercialization. It also explains how to enhance speed to market and improve quality with a templated process.

  • With gene therapy, diseases that lacked cures or even treatments may be addressed with these new classes of therapeutics. This potential has spurred new investments in the drug development and commercialization space.

  • With the current increase in development and investment, gene therapy companies will increasingly be looking to streamline the manufacture and commercialization of their therapies. Choosing a contract development manufacturing organization (CDMO) to ensure a smooth road to commercialization is essential. Contact us directly to learn more about picking the right strategic partner.

  • While the fastest path is often tempting, the right path is to ensure product quality and viability while expediting the development timeline. These five steps are key to putting your molecule on the right path.

  • In January 2020, the United States Food and Drug Administration (FDA) released several new or updated guidance documents pertaining to human gene therapy products. This paper summarizes several key changes that will impact developers of gene therapies.

  • While quality management is a major priority across the life sciences industries, it takes specific precedence in viral gene therapy. Heather Burnell, Head of Quality at MilliporeSigma’s viral vector manufacturing facility in Carlsbad, CA, highlights how quality management is embedded in the MilliporeSigma culture.

  • Process development (PD) is a critical component to the commercialization of viral vector-based therapies. While some gene therapy developers may want to speed through this operation to meet deadlines, doing so can put product quality, safety, and efficiencies at risk.

  • Biopharma 4.0 is becoming more tangible every day. Catch up on the initiatives and programs that are defining the application of Industry 4.0 principles for MilliporeSigma technologies and services.

  • On the road to becoming a global industry leader in cell and gene therapy, our viral vector manufacturing organization has undergone a major transformation over the last two decades. Marc Gaal, Director of Program Management at MilliporeSigma, details the history of the business as well as some of the milestones achieved since its inception.

  • The last decade saw a great rise in gene therapy popularity. Today, gene therapies have reached a momentum with hundreds in clinical development and several therapies approved in recent years. However, the rapid growth of the sector and the complexity of gene therapies has resulted in a number of challenges in process development, scale-up, manufacturing, and regulatory guidelines. Download the infographic to find out how to overcome these challenges and what’s ahead for gene therapy.

  • The production of viruses, whether for use as viral vaccines, viral vectors for gene therapy, or oncolytic applications, requires complex processes that can translate into high costs, as well as slow development timelines and time to market. This article presents several case studies highlighting the advantages of process intensification using Natrix® single-use membrane chromatography to increase your productivity and reduce your capital and operational manufacturing costs.

  • By delivering significantly more data than traditional Sanger-based sequencing methods, NGS opens a range of possibilities for the analysis of diverse DNA and RNA populations.