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.

Bio4C™ ProcessPad software is a data collection, visualization, and analytics software platform that facilitates 21 CFR Part 11 compliance and enables bioprocess monitoring, lifecycle management, reporting, investigations, and continued process verification (CPV).

Accurately and reliably verify the integrity of your filters and processing equipment with the portable, easy to implement, and automated Integritest® 5. The Integritest® 5 delivers a simple and intuitive user experience, while providing optional depth of flexibility to fit your process.

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.

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.

You need the right data at the right time from your supplier to make important production and supply chain decisions to achieve your biopharma manufacturing goals. The eMERGE™ Program is our standard platform for the exchange of electronic data. It provides key raw material data electronically for every shipment, so you can start making informed decisions right away.

It’s a familiar scenario: opening a package of bulk material that’s been in storage for a while only to find it has formed clumps, caked together, or – at worst – even completely solidified. A lot of biopharma businesses have learned to simply deal with this irritation. Unfortunately, current anti-caking solutions tend to be inadequate and time-intensive, merely addressing the symptoms without preventing caking in the first place. What if there were a technological solution to the caking challenge?

High-quality plasmid DNA is a key component in cell and gene therapy manufacturing and as such is in high demand. This has led to the need to optimize manufacturing to meet the demand for volume as well as the quality required for use in the manufacture of therapeutics. Read on to learn from a team of experts as they answer questions on plasmid DNA production for cell and gene therapy applications.

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.

This app note describes improvements made to the downstream portion of the process, specifically, use of single-use technologies and novel techniques for clarification and ultrafiltration/diafiltration. 

Read about the GMP transferable process for adenovirus vector-based vaccines manufacturing that was successfully developed with Jenner Institute.

Low-pH condition during elution in Protein A chromatography, as well as during virus inactivation may induce protein aggregation. This study shows that the addition of excipients have a beneficial effect of the purification during Protein A chromatography and virus inactivation, without harming the subsequent chromatographic steps.

The biopharmaceutical industry is in the midst of a period of rapid growth. It is also experiencing increasing uncertainty, diversification of modalities, and cost pressure. To address these challenges, the industry will need to embrace the facility of the future – a new biomanufacturing paradigm. This infographic identifies market trends challenging biopharmaceutical companies, business drivers to meet market needs, as well as requirements and aspirations for the factory of the future.

This white paper describes a novel, integrated approach to intensified buffer preparation and how this strategy can increase process flexibility, efficiency and reduce costs.

mRNA has emerged as a promising modality for a wide range of therapeutics and vaccines and could become the break-through technology of this century. This technology will not only revolutionize the field of vaccine development by allowing a rapid response to disease outbreaks, it will also help to address diseases of unmet medical need with gene therapy approaches or cancer treatments. Learn more with our white paper.

How a collaboration with MEVAC optimized filtration strategies used in upstream and downstream processing of a foot and mouth disease virus vaccine to ensure scalable, cost effective GMP.

We have added a new Dry Powder Media (DPM) manufacturing facility to the existing Irvine, Scotland liquid media manufacturing site. The expansion of dry powder milling and blending capability to the facility is part of our long-term commitment to supporting customers in the growing industrial biopharmaceutical market. This article highlights the results of a comparability study thaqt was performed to demonstrate the manufacturing processes and equipment used to produce cell culture media at the Irvine, Scotland (Irvine) site are comparable to those used to produce media product at the Lenexa, Kansas (Lenexa) site.

Dry granulation can be a method to overcome caking issues and improve handling of buffers, salts and stabilizing chemicals without using additional additives. How does it impact sensitive materials and their material properties?

RNA and DNA therapeutics are a powerful means to treat, and in some cases cure, otherwise unadressable diseases. This whitepaper focuses on lipid-based RNA therapeutic development.

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.

Pyrogen detection is one of the mandatory release tests for sterile parenteral drugs. Another test method that has increasingly been used the past few years does not need animals for pyrogen detection. The monocyte activation test (MAT) uses human monocytic cells to mimic the human reaction to pyrogens in vitro. This article looks into the the MM6 cell line, which has been validated for the use in the MAT and is listed amongst the valid sources of monocytes for the MAT in the European Pharmacopeia.

This white paper describes the use of PVA-based Parteck SRP 80, a functional excipient specifically developed for matrix-based sustained release oral solid dose formulations.

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.

Purification of pDNA for use as vaccine doses presents several challenges. This application note presents a comprehensive set of technologies that are available to optimize the entire workflow.

Learn how Bio4C ProcessPad meets 21 CFR Part 11 requirements including unique usernames and passwords, timestamped audit trails, and secure storage of all records.

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 paper describes a robust, global manufacturing network for cell culture media that supports capacity expansion to meet growing demand and ensure business continuity.

In this white paper, we highlight the breadth of programs implemented across our organization to safeguard the quality of the cell culture media that are used in our customer processes.

Due to their structure, plasmids can sometimes pass through pores that are smaller than their apparent molecular weight. Additionally, the DNA can be shear-sensitive and tends to increase with plasmid size, and the result can be degradation and reduction of the overall yield. Learn how optimization of hydraulic parameters can help you achieve the desired plasmid purity, formulation, and concentration specifications.

Plasmid DNA (pDNA) is typically produced via fermentation using a microbial source. Following E. coli fermentation, the primary downstream purification begins with harvesting of the cells, lysis, and clarification. Explore guidance for your pDNA downstream process development, including clarification, TFF, chromatography and sterile filtration unit operations.

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.

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.

In response to the SARS-Cov2 pandemic, vaccine manufacturers must ramp up quickly and establish capabilities to produce and distribute an effective vaccine to a global population. This infographic presents an overview of cost-effectiveness in using single-use technologies to achieve this objective.

This white paper provides an overview of the short-, mid- and long-term strategies we have developed, implemented, and continue to advance in response to the pandemic. Learn more!

Single-pass tangential flow filtration (SPTFF) can be used to drive flexibility, lower cost, and higher product quality. Read the application note to learn more.

The large size of pDNA can present a challenge for sterile filtration unit operations within your gene therapy manufacturing since the product can be retained by the filters, leading to both yield loss and low filtration capacity. Optimization of a sterilized grade filtration unit can help increase yield and filtration capacity. Read on to learn more!

Widespread application of pDNA in gene therapy is driving increased demand and as a response, plasmid manufacturing must become more efficient with improved productivity. Intensification of chromatographic steps can help address this demand and has led to an exploration of the use of convective media (monoliths, membranes, fibre based technologies).

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.

During a bubble point test, pressure decay measurements are taken at increasing applied transmembrane pressures to map the filter’s integrity profile. The Integritest® line of automated integrity testing instruments identifies optimum pressures at which to take measurements based on test parameters and ongoing readings, which reduces the number of measurements needed to reliably map the filters’ profile and return an accurate result.

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.

In final filtration and filling operations, where maintaining sterility is critical to assuring drug safety for patients, sterilized single-use assemblies offer many advantages. This application note describes testing performed to assess volume loss in SURF assemblies and shows how both assembly design and filtration operations can be adapted to minimize volume and product loss in the system.

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 information available, in parallel with a reduction in the cost of obtaining, processing, and transmitting information, is changing the way biopharma manufacturers operate. 

Driven by 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 resources. 

Owing to the sheer volume of data streaming from sensor profiles, anomalies observed during process monitoring in historical data are extremely difficult to search due to a lack of time series search tools. 

In this tech note, we investigate the interactions between the spike glycoprotein binding with ACE2, binding with mAb/pAb to inhibit the interaction with ACE2, and spike glycoprotein and anti‑spike antibodies.

A new platform that includes digital technologies/data management, process analytical technologies and intensified processing will drive next generation bioprocessing.

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

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 complexity of processes to manufacture cell and gene therapy medicinal products can cause confusion around definitions of raw materials, starting materials, process intermediates, drug substance and drug products. This document will discuss the definitions of the above process components.

Viral contamination is a risk for all biotechnology products. Establishing robust viral removal/inactivation steps mitigates the risk of adventitious and endogenous viral contamination and is essential for ensuring the safety of gene therapy products. Recent studies have shown that viral retentive filtration is one of the most robust steps in removing all types of viruses. In this study, we focused on the initial development process of the retroviral-retentive Viresolve® NFR filter.

Clarisolve® depth filter with pDADMAC flocculant pretreatment demonstrates a significant improvement in filtration efficiency, including a reduction in supernatant turbidity and improved volumetric throughput compared to conventional filters. The purification process removes the residual polymer to a concentration less than 1 ppm, where it showed no in vitro cytotoxicity and hemolytic concerns, and could be used as a reasonable target for acceptable polymer clearance. Overall, pDADMAC treatment in combination with Clarisolve® depth filters provides an effective solution for harvesting high-cell-density cultures and can be easily incorporated into current clarification platforms.

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!