New family of our housing portfolio designed to meet the demands of filtration process design. Series 4000™ housings have been designed in accordance with the life sciences industry’s demand for high-quality and cost-effective products. Our Series S4000™ housings are suitable for use in a wide range of applications with low dead volume, minimizing product loss and enhancing cleanability. The products are available in T-Line and In-Line configurations including the 5, 10 ,20, 30-inch sizes in Code 7.

The Mobius® Chrom 20 system is a flexible, automated, single-use chromatography system that enables consistent and reliable separation and purification of mAbs, vaccines, plasma, and therapeutic proteins at clinical and process scales.

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.

The benchtop Cellicon™ Perfusion Solution is designed to meet your perfused seed train challenges.

Cellvento® CHO media are designed to support growth and maintenance of specific CHO cell lines in suspension cell culture for expression of monoclonal antibodies and recombinant proteins. The new Cellvento® 4CHO-X Expansion Medium supports cell expansion including N-1 perfusion for Chinese Hamster Ovary (CHO) cell lines.

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

Plasma Fractionators play a critical role in the treatment of rare life-threatening conditions. Consistent, reliable performance is key to plasma fractionation – and that means choosing a partner who understands your challenges of improving yield while maintaining process economics and managing ever-increasing regulatory requirements.

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.

Millipore Express® SHC (Sterile, High Capacity) filters provide superior throughput and capacity in applications where sterilizing-grade performance is needed and premature filter plugging is a concern. These filters are ideal for sterile filtration of cell culture media, protein solutions and other high fouling fluids. Millipore Express® SHC filters contain two polyethersulfone membrane layers, 0.5 μm/0.2 μm, and come in a range of device formats and sizes to suit your application needs.

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.

Viral Resistance For The Future.
Centinel™ technology goes beyond viral insurance. It’s an integral component of a sophisticated virus mitigation strategy for preventing, detecting and removing viruses.

The next generation parvovirus safety solution designed to provide the highest levels of retention assurance and productivity.

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.

A dramatic increase in the amount of information that is available, in parallel with a reduction in the cost of obtaining, processing, and transmitting information, is changing the way biopharmaceutical manufacturers operate. Access to information, and more importantly, strategic use of it, can give a company a competitive advantage.

The development and implementation of analytical methods are essential for success at all phases of a molecule’s journey, from pre-clinical development, to clinical manufacturing and ultimately, commercialization. Driven by the need for rapid advancement towards key milestones, an early-stage company must optimize the balance of speed and safety, while ensuring quality and gathering important information about the molecule.

Because of the urgent demand for treatments, vaccines and assays, the pharmaceutical and biotech industries are experiencing disruptive, often chaotic, increased demands on its resources. This industry adaptability is already helping the industry re-tool for rapid development and production of pandemic vaccines, therapeutics, equipment and diagnostics; while also responding to changes that this worldwide mobilization of resources will bring to the industry.

The race is on to get biotherapeutics to market faster as every day of delay is delayed access for patients and can result in millions in lost revenue. Following successful Industry 4.0 implementation in the automotive, communications, aerospace, and other industries, the biopharmaceutical industry is now joining the digital revolution to meet the manufacturing challenges of today and tomorrow.

Biomanufacturers are facing immense pressures to increase their productivity and deliver high-quality biotherapies to market faster. This blog explains the “4 Cs” of Biopharma 4.0 – the software, automation, and analytics tools that provide interconnection, information transparency, and decentralized decision making.  

Lipid-based drug delivery systems offer several advantages, including improving the stability, solubility, bioavailability, and toxicity profiles of active pharmaceutical ingredients (APIs). It is essential to select the optimal lipid excipients with the appropriate characteristics for each specific API and application and to ensure that they can be produced using high-quality production methods that are scalable for GMP manufacturing. Working with the right supplier that offers consistent, high-quality products and has expertise in the drug development process and the regulatory environment is essential for the successful development and commercialization of lipid-based drug products.

As industry 4.0 principles are applied to the biomanufacturing arena and innovative digital technologies emerge, one might refer to the phenomenon as “convergent bioprocessing.” 

Several challenges are associated with use of an adherent platform for lentivirus production. This white paper describes considerations for suspension-based, transient transfection bioreactor process development and scale-up of lentivirus production. We will describe the approach taken for process development.

An overview of the challenges presented by current approaches to virus production and a platform approach that can work across different viral modalities and accelerate process development.

In this ebook, we describe four areas of development where we have applied a strategy to accelerate timelines, mitigate risk, and ensure uncompromising quality.

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.

One of the biggest decisions a biological medicine developer makes is to move forward with manufacturing theirproduct. It's one of the most costly and complex decisions you'll make.

This paper describes rapid identification of high-producing cell lines, media feed optimization, and a bioreactor scale-up approach for consistent, reliable upstream bioprocess development.

The safety of biologics from adventitious agents requires a multilayered strategy of controlled manufacturing processes and risk mitigation to prevent contamination. 

Upstream intensification is one strategy that will enable the Facility Of The Future by significantly driving down costs through an increase in volumetric productivity. Read the white paper to learn more!

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.

In the last decade, biopharmaceutical industries have had to mobilize quickly in response to pandemics. Vaccine development typically requires many years and manufacturing large doses in an emergency is a challenge. To reduce investment risk, biomanufacturers wait until a vaccine is in the advanced stages of testing before starting to manufacture. This conventional development strategy compresses during a pandemic. Read our white paper to learn more.

In this ebook, our experts share some critical success factors for your analytical program—including speed, risk, and cost—and how a risk-based approach can effectively get you to your next milestone.

In this white paper, we explore various strategies for the intensification of upstream perfusion processes with cell retentio technologis and the viability of each solution.

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

This whitepaper explores the factors driving the evolution toward faster biosafety testing and describes rapid approaches for adventitious agent testing that are more aligned with manufacturing trends.

What technologies should you apply to your vaccine-specific process? Vaccines have been protecting against disease since the late 1700s. They function by triggering the immune system to generate short-term and long-term responses. Because there are many pathogens, there are also many vaccines. They can be classified by antigen character, but the manufacturing flows used to produce them are relatively similar. Learn more on similarities and differences.

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.

This whitepaper provides a summary of regulatory guidelines for sampling, describes traditional methods and their limitations, and explores the advantages of aseptic, single-use to align with regulatory guidelines.

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.

This white paper describes process modeling and compares the process economics of a conventional upstream process versus three perfused seed train alternatives in combination with either a conventional fed-batch bioreactor or high-seed fed-batch bioreactor. 

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.

Recently approved cell and gene therapies are delivering impressive results for patients who otherwise have exhausted all treatment options or have had no options available to them. However manufacturers are faced with many challenges in the journey from development to commercialization. Within this challenging environment, 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 these remarkable therapeutics.

High cell density cryopreservation and the use of a perfused seed train and specially-designed expansion medium can create shorter lead times, reduce plant footprint, increase flexibility and reduce COGs.

While these new modalities are generating significant excitement among patients and caregivers, cell and gene therapy manufacturers are experiencing growing pains. The rapid growth and continued momentum of the industry has led to the issuance of new guidance. In this article we share insights for navigating within a novel and complex regulatory environment, mitigating risks posed by raw materials and implementing proper risk assessments during manufacturing.

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.

This article explores the strategies and close collaboration employed by MilliporeSigma to design quality into resins and membranes and to help customers minimize variability in their purification process.

Even as alternative methods such as PCR and NGS have emerged, in vivo tests have stubbornly remained a central part of testing. Here we examine current in vivo methods and explore modern alternatives.

This white paper explores key components of a chromatography resin supply chain program to help customers control their supply chains and ensure steady progress towards milestones.

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 key to a biopharma executive's success is making the right decisions at the right time. Which will get your biologic to the clinic quickly and cost-effectively, without compromising quality and patient safety?

A major contributing factor to drug shortages is the availability of raw materials. Read how greater transparency in supply chains will help address shortages.

With next generation bioprocessing and innovations in detection and clearance technologies it is time to rethink the traditional approaches to viral safety

Setting up systems to automatically compile data and analyze it on a routine basis versus just collect it reduces workloads, provides timely access to critical information, and allows for data-driven decisions.

Supply chains are increasinly complex. Collaboration can give you confidence in supply robustness and control. This collection of articles offers tips and insight to keep your supply chain running smoothly.

This white paper showcases the efforts carried out by the DiViNe consortium to advance the use of an innovative affinity chromatography platform during vaccine manufacturing.

This whitepaper describes our collaboration with the Jenner Institute, Oxford University to develop an optimized, single-use GMP process for manufacturing adenoviral vector-based vaccines.

This e-book contains a series of case studies highlighting our recent collaborations with organizations and thought leaders on the front lines of the battle against challenging pathogens and infectious diseases. 

Leveraging the hyper accuracy of Droplet Digital PCR (ddPCR), viral and gene therapy developers gain additional confidence in tittering assays and vector copy number determination.

This paper examines adaptations to current technologies for downstream processing, such as clarification and chromatography, that facilitate more suitable conditions for continuous bioprocessing applications.