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.

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.

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.

pDNA has become an important therapeutic modality in the form of DNA vaccines and as the basis for RNA vaccines and gene therapy vectors. Purification of pDNA for use as vaccine doses, however, present several challenges. This application note presents a comprehensive set of technologies that are available to optimize the entire workflow.

To promote the use of state-of-the-art technologies while ensuring that these new software solutions meet the safeguards and regulations of traditional paper-based record keeping, the FDA issued 21 CFR Part 11 regulations to establish standards under which new electronic documentation and electronic signatures are regarded trustworthy and reliable. Bio4C™ ProcessPad software is a data visualization and analytics platform that securely acquires and stores batch processing and analytical testing data and makes the data available for investigations, reporting, and bioprocess monitoring. Bio4C™ ProcessPad facilitates 21 CFR Part 11 compliance by meeting applicable 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.

Benzonase® endonuclease is a high-quality product delivering immense value to viral vector processes. The enzyme activity is strongly influenced by the matrix and optimization of its use should be a mandatory step in process development. In this application note, we highlight an optimization strategy and process economics of DNA digestion in viral vector purification.

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 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.

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. See how Bio4C™ ProcessPad’s new “Pattern Search” feature provides process engineers this ability to easily extract an anomaly profile from a time series for a time-range or within a batch.

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!

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.

Perfusion operations deliver high density cell cultures that alleviate the burden of processing large production bioreactor volumes while increasing manufacturing flexibility. 

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.

By amplifying multiple targets within a conserved region of the viral family genome, Blazar detects a much broader range of adventitious viruses as compared to traditional polymerase chain reaction methods.

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.

With the outbreak of COVID-19, the most severe pandemic in the 21st century so far, a feverish search for therapeutic treatment and vaccinations has just started. A substantial number of approaches are focusing on the coronavirus S glycoprotein, a surfaceexposed protein that mediates the entry of the virus into the host cells. The aim of this technical note is to provide a description of the capture and subsequent purification of glycoproteins.

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.

This application note describes the steps followed and considerations taken during the development of antibody drug conjugate separation using a mixed mode cation exchange chromatography step.

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.