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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.

VIDEOS

The cell and gene therapy industry is rapidly evolving from the perspective of “can we commercialize this class of therapeutics?” to “how do we reach patients who need these therapies?”. However, the promise of these biologics can only be realized if the industry approaches manufacturing parity with monoclonal antibodies. A mixture of innovation and brute-force streamlining is needed to create viable cell and gene therapy templates. In this video, we discuss how upstream process optimization is ripe for innovative approaches.

You’re a pioneer on the right path forward. Our combination of extensive products and services portfolios and expertise enable biotech start-ups to move beyond risks, accelerate their development timelines, and successfully navigate the path to commercialization. Understanding that not all biotech start-ups have the same needs, at the same time, or in the same way, you can select the path that is most appropriate for you, when you need it.

The MilliporeSigma organization is dedicated to supporting your cell and gene therapy from early phase through product release.  Not only does our BioReliance® Services organization have over 25 years of experience in manufacturing viral vectors, we can also leverage the innovative products and services within the wider organization to support your therapy. This video will highlight three ways you can partner with us to optimize the productivity of your cell line. For those beyond the discovery phase, this video will highlight how our Process Development group helps ensure success from clinic to commercialization.

Risk of contamination associated with traditional sampling methods using SIP valve/welding can have a financial impact on your process sampling plan. Find out how much NovaSeptum® GO sterile sampling system can save you by reducing operator related costs while drastically reducing sample contamination risk and sample loss.

Harmonization of sampling processes across your entire biomanufacturing production is possible using sterile sampling methods. Learn how to implement sterile sampling solutions that meets and exceeds sampling and sample storage/retainment guidelines and to reduce contamination risk during process sampling.

Early in the development of viral vector gene therapies, it’s critical to design a strategy that supports commercial needs based on clinical indication, patient population size and dosing requirements. This video reveals the most important factors to consider when scaling up.

Costly mistakes can happen when rushing through process development to produce curative therapies for genetic diseases.  Learn about 3 key strategies that can be leveraged to improve product yield, quality, and patient safety.

Viruses are widely used in many vaccines and therapies. Despite the difference in application there are similar process challenges. Learn how to overcome those challenges in this video.

Manufacturing costs present a key challenge to gene therapy commercialization. Cost Modeling can help make informed decisions to reduce manufacturing costs. Uncover 3 key insights in this video.

Learn how to mitigate regulatory risk for your gene therapy process.

MILLIPORESIGMA PRODUCTS

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.

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® Power MIX 2000 single-use mixing system is engineered with advanced technology to effectively handle difficult-to-mix buffers, culture media powders and other pharmaceutical ingredients. The Mobius® Power MIX achieves a strong vortex using an impeller design and motor based on magnetically-coupled NovAseptic® technology, a proven mixing technology in stainless steel tanks. The Power MIX 2000 provides accessible, sterile zero deadleg sampling directly from the mixing container. A Probe Port allows for insertion of either a reusable probe for non-aseptic processes or a pre-sterilized, single-use sensor for in-process pH measurement of aseptic processes. Other design features make the mixing system easy to use, enabling loading of bags by one person and offering an optional integrated hoist for powder delivery.

CONTACT INFORMATION

MilliporeSigma

400 Summit Drive

Burlington, MA 01803

UNITED STATES

Phone: 1-800-645-5476

FEATURED ARTICLES

  • Widespread application of plasmid DNA (pDNA) in vaccines and gene therapy is driving increased demand. As a response, plasmid manufacturing must become more efficient with improved productivity. This process development guide provides you with guidance for your plasmid DNA downstream process development, including clarification, TFF, chromatography and sterile filtration unit operations.

  • While a variety of topics were covered during the Biotech Start-Up Symposium in April. This blog reviews a recurring theme at the symposium - the importance of raising venture capital to fund new technology research and development.

  • LifeScience, Inc. is a start-up biotech going for Series A or B financing. Their targeted asset has several potential indications. They have a critical vacancy in a pivotal role. The kicker is, they need to fill the job quickly, because they want that Perfect Person to be part of their business plan and to attract the next round of funding. Here are the most common hiring mistakes that many life-sciences companies make, along with some advice I’d like to share with you.

  • 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.

  • China is going through a phase of robust growth of biotech companies. This is being boosted by market demand, returning scientists-turned innovators and a favorable capital market. This is especially the case in the Science and Technology Innovation Board in China (STAR) and the Hong Kong Stock Market.

  • 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.

  • Speed to the clinic and patient safety are important goals when working to bring novel genetic therapies to patients. Read how Homology Medicines decided to invest in internal development and manufacturing operations not long after the Company’s founding. This allowed for efficient collaboration, integration, and iteration as Homology developed a commercial platform process that supports both gene therapy and gene editing constructs.

  • 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.

  • Depending upon your perspective, “emerging” biotech could mean any number of things, ranging all the way from the recent spinout of an academic lab to a publicly held company developing a therapeutic that has not yet reached the marketplace. Read more about what current situations may cause anxiety for a company in the emerging biotech space.

  • 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. 

  • 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.

  • Gene therapy has the potential to change countless patients’ lives. 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.

  • This article demonstrates that depth filters clarify AAV vectors, helping to overcome the unique separation challenges presented by these important vectors for gene therapy.

  • 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.

  • Hiring bioprocessing pros has been a stubborn problem for more than a decade, challenging start-up companies as the supply of qualified staff gets tighter. Here's how the industry could solve the problem.

  • 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.

  • 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.

  • Cell therapy, gene therapy, and RNA-based therapies. Right now, those are the classes of therapies we’re considering novel. If you look at it historically, ten years ago, recombinant proteins and monoclonal antibodies would have been novel therapies, but now they’ve become very much standardized. So now that bar has moved a little bit, and the novel therapies are really cell and gene therapies, and to a certain extent the RNA therapies.