HOW CONTROLLED FREEZING ENABLES SCALABILITY: Controlling the freezing behavior of drug substance is the ultimate goal in pharmaceutical manufacturing. It opens doors to process reproducibility, consistent quality of the final drug product by maintaining uniform conditions for the biopharmaceuticals during freezing and consequently for frozen storage and shipment. As one of the most essential parameters to achieve control over freezing & thawing bulk, the freezing rate has been considered and evaluated in different tests. The leverage of the ice front growth speed had a significant impact on the control and as a result on the quality of the protein. Download this special report from Single Use Support to learn more about how single-use systems provide the best solutions for the industry.

Filtration of protein-based biologics is essential for minimizing viral contamination and ensuring product safety and high quality. The tendency of therapeutic monoclonal antibodies (MAbs) and recombinant proteins to aggregate under a number of conditions can complicate selection of a virus filter. An increasing demand for high concentration formulations creates additional challenges. When performing filterability studies and to ensure meaningful virus filter evaluations, downstream process scientists must address factors that can lead to aggregation. This special report on virus filtration by scientists at Pall includes discussion of minimizing protein aggregation through formulation and handling considerations. Download now to learn more.

Due to the complexity of biologic development and manufacturing and the business pressures of the biopharmaceutical industry’s landscape, the margin for error in today’s industry is small. That is why minimizing the threat of contamination is critical when using a closed system for drug development and manufacturing. Yet the traditional method of connecting each step in a closed process can present other risks to the integrity of your product. Therefore, it is important for you to be confident in selecting single-use sterile connectors that meet the specific sterility and reliability needs for your application. In this BPI Special Report, Todd Andrews of Colder Products Company (CPC) explores how single use technology provides flexibility, helps with process optimization while reducing risks association with contamination and leaks. Read the full report now to learn how single-use connectors can help increase the integrity of closed systems.

The process from drug development to market approval takes many years and requires both integration and orchestration of several activities based on deep scientific and commercial expertise. We tend to think of drug development as a sequential, phase-driven process during which a product is taken methodically from discovery through preclinical studies, clinical development, and ultimately commercial launch. In reality, development of new drugs is not linear; rather, it requires integrated coordination between collaborators from different functions and stakeholders — from a program’s outset — to help ensure success. Too often, the different activities involved in drug development are managed in functional siloes rather than through integration. This lack of integration and coordination can affect a development program adversely in several areas, from regulatory submissions to process development, outsourcing, and marketing. In this special report, Mark Lane of PharmaLex explains that an integrated product ...

Messenger RNA (mRNA) emerged as a powerful therapeutic tool for treatments in gene therapy, oncology, and infectious diseases, as recently demonstrated by vaccines against Covid-19. mRNA is produced by an enzymatic reaction that can be rapidly designed and scaled-up, and the platform is highly adaptable to different targets. One of the greatest challenges in mRNA production is the removal of process-related impurities stemming from in vitro transcription (IVT) reaction, such as residual nucleotide triphosphates, DNA template, enzymes, abortive transcripts. Affinity-based chromatographic isolation of mRNA is robust and simple, lending itself as a useful industrial platform. mRNA constructs typically contain a 3’ polyA tail to increase stability in vivo, thereby enabling affinity purification using oligo-deoxythymidinic acid (Oligo dT) probes covalently coupled to a solid support. Macro-porous polymethacrylate monoliths offer high binding capacity and resolution for mRNA due to the convective nature of inte...

Discover how Pall Corporation and Lonza collaborated to improve single-use technology training for operators using a blended approach to learning. This article presents: Download this article today and learn how to increase the speed and efficiency of your operator training on SUT.

The optimization of the downstream process for Adeno-associated virus (AAV) production with consistent quality depends on the ability to characterize critical quality attributes affecting potency, purity and safety of the final product. As the gene therapy field continues to push products through the clinical pipeline, an increasing need for efficient purification and analytical tools has become evident. In addition, the regulatory space has expanded in parallel to the use of AAV, driving the demand for simple and efficient assays to demonstrate product quality and safety. Read on to learn more about efficient AAV purification tools and characterization steps to consider when manufacturing an AAV drug product. Fill out the form below to read this special report now.

Rapid response to global pandemics requires the manufacture of billions of vaccine doses within months. This short timeline must allow for design and testing of active ingredients, development of production and purification processes, clinical evaluations, regulatory filings, and manufacturing. Existing purification methods often have been adopted from laboratory-scale techniques to allow rapid implementation, and those have provided adequate product quality. But future mRNA development will require optimized production and purification processes. Chromatography has been a workhorse of biomanufacturing for decades, including for monoclonal antibodies, plasmid DNA, viruses, and other modalities — as well as for supporting analytics. As an emerging therapeutic modality, mRNA production requires the development of new methodologies to suit its peculiar physicochemical profile: large, charged, and relatively unstable. Due to requirements for high purity, these methodologies will be based in large part on chro...

Analyzing for viable cells using traditional methods such as flow cytometry often encounters clogging resulting in the loss of precious cell therapy samples. Not only is it low throughput, but incredibly complicated, which can lead researchers to misidentify cellular and non-cellular material and confuse cell viability results with product-purity issues. Additionally, it is a regulatory requirement for all injectable drug products be characterized for sub visible particles (SVP) and aggregates that may form during a manufacturing process. With Backgrounded Membrane Imaging (BMI) and Fluorescence Membrane Microscopy (FMM), Aura CL performs cell viability assays with definitive cell identification for 96 40-μL samples in about an hour. Without any effort, Aura CL can identify and quantitate non-cellular particles, protein and cellular debris, viable and non-viable T cells. Aura CL empowers users who need to characterize SVPs in cell therapies. Fill out the form below to read the complete report now.

Recombinant lentivirus (LV) and adeno-associated virus (AAV) are critical components of cell and gene therapies, which show great promise for treatment of diseases from genetic disorders to cancer. Accordingly, there is an unprecedented need for high titer and large-scale viral vector manufacturing processes to support the growing number of researchers developing biotherapeutics for immunotherapy. Download this Special Report, highlighting: Fill out the form below to read the complete report now.

Current demands placed on the biopharmaceutical industry are pushing manufacturers toward process intensification, an approach that modifies unit operations or an entire manufacturing process to optimize efficiency. Three common intensification scenarios in upstream processing are seed-train intensification (usually at the n – 1 stage), concentrated fed-batch production, and dynamic perfusion (at the production bioreactor stage). In downstream processes, intensification strategies typically involve moving from single- to multicolumn chromatography. Biomanufacturers can realize several kinds of improvements from intensified processing, including reductions in operation costs, faster production schedules, increased yields, and enhanced flexibility. This special report from writers at Sartorius explores how adopting single-use intensified manufacturing satisfies key business drivers. First, the report provides a process-decision matrix that simplifies the implementation of process intensification in both n...

To prepare adequate healthcare measures in the case of a pandemic, vast numbers of people must be tested in order to understand the dynamics and behavior of the infection cycle. The medical staff working under extreme circumstances need basic but reliable laboratory supplies to help contain the pandemic. Read this special report to discover two solutions for COVID-19 patient testing that comply with guidelines from the US Centers for Disease Control and Prevention (CDC) and World Health Organization (WHO). The first part of the report focuses on the benefits of using an ergonomic electronic Picus pipette to perform reverse transcription polymerase chain reaction (RT-PCR) assays. The second describes collection and transportation of clinical specimens containing live SARS-CoV-2 coronavirus using viral transport medium (VTM). Fill out the form below to read the special report and learn more about COVID-19 patient testing solutions now.

The high costs of therapeutic discovery, development, and manufacture require improved process efficiencies and economics. Analytical tools that eliminate the need for reagent labeling and enable real-time data visualization save development time and improve efficiencies during process development. The Octet biolayer interferometry (BLI) platform and assays can be used throughout process development and manufacturing, including cell-line development, clone selection, and dynamic binding capacity (DBC) determination for affinity purification columns. The ability of the Octet BLI platform to monitor binding interactions in real time, coupled with its capability to analyze samples in their crude matrix and in high throughput, can help shorten development and analysis times, leading to significant cost savings and dramatically improved process economy. Fill out the form below to read this special report and learn more about the Octet BLI platform now.

Single-use biopharmaceutical manufacturing systems require gamma-sterilizable, highly stable, accurate, and simple-to-use single-use pH sensors with a long shelf life. Herein we report the design and performance of a single-use pH sensor technology optimized for single-use bag applications such as those found in bioreactor and mixing applications. This technology is the basis of Emerson’s Rosemount 550pH Single-Use Sensor. The sensor is compatible with gamma irradiation and can be attached to a single-use bioreactor bag via industry accepted ports. With the incorporation of a unique storage buffer solution, the sensor has a long shelf life of two years and offers a startup one-point standardization and validation capability without the need for filling the bag. Sensor prototypes were constructed and tested through real-time aging. It was demonstrated that the sensors remained high performance after two years of storage, with a startup accuracy of ± 0.1 pH at pH 7, a wide pH sensing range between pH 2 and ...

Process monitoring entails systematic recording or measurement of an operation or process by means of technical aids. Repeated, regular execution is a central element of that activity. Statistical process control and management help to optimize and stabilize processes. They also ensure appropriate monitoring of threshold values. Ultrasound-based clamp-on flow meters are ideal measuring methods for that purpose because they enable data collection without requiring operators or equipment to intervene in a process. Noncontact flow sensors also combine high precision with easy application. In this BPI special report, Fernando Rangel explains how modern ultrasonic flow sensors from Sonotec enable contactless flow measurement of a wide range of liquids in flexible tubing. The report demonstrates that such technologies can take measurements over a wide flow range with an accuracy of ±2% of the measured value. Under varying media properties and over a wide temperature range, an accuracy of ±5% of the measured va...

Cell culture and bioprocessing conventional wisdom remains a hurdle for the wider adoption of more precise tools. It has been more than 60 years since any real progress has been made towards creating a more accurate and reliable way of performing cell culture monitoring to better understand the effects of things like pH and oxygen at the pericellular level. At SBI, we’re developing optical sensing technologies that unlock the “black box” of cell culture to bring actionable insights to scientists and researchers for faster scale-up. The flexibility of optical sensors allows for real-time monitoring anywhere within a culture vessel or bioreactor, making experiments more reproducible. In this report, we’ve pulled together a list of five heresies of cell culture that have been published in peer-reviewed journal articles to illustrate the required transition from conventional cell culture wisdom to this new and better way forward for scientists and researchers. Fill out the form below to read the Special Repor...

Using presterilized, single-use freeze–thaw systems instead of traditional freeze–thaw platforms that include stainless-steel tanks and bottles can help biomanufacturers manage the quality of their drug substances. Single-use assemblies reduce the risk of cross-contamination, simplify dispensing, and decrease the number of manual interventions during freezing, thawing, handling, and shipping. However, implementing a freeze–thaw process requires careful testing of the physical and thermal properties of single-use systems and related aseptic connectors as well as assessment of drug-substance quality and stability. Such evaluation has become even more critical than ever as drug companies continue moving their freeze–thaw processes to the lower end of the industry-standard range (–20 °C to –80 °C ). In this BPI Special Report, Derek Pendlebury of Colder Products Company (CPC) explores criteria for selecting and implementing aseptic connectors that perform well in extreme temperature conditions. Read the repor...

As viruses can arise during the manufacture of biopharmaceuticals, regulatory agencies require viral clearance validation studies for each biopharmaceutical prior to approval. These studies are typically conducted in biosafety level (BSL)-2 facilities and require large capital and human resources. The use of an accurate, economical, and quantifiable noninfectious viral surrogate would enable downstream purification scientists to study viral clearance throughout process development. This report explores the use of a BSL-1 compatible, noninfectious MVM particles to predict viral clearance results over a wide variety of process development applications such as anion-exchange chromatography (AEX) design of experiments (DOE) study, ion-exchange chromatography (IEX) high-throughput screening, and downstream purification of an adenoassociated virus (AAV)-based viral vector. Fill out the form below to read the special report now and learn more about applying a noninfectious viral surrogate to help study viral cle...

With the increasing development of viral vector and virus-based vaccines, technologies that help to manufacture and scale up these types of vaccine quickly and cost-effectively have become more critical. By accessing this special report from Aditya Bhat, a capacitance technology expert at Aber Instruments, you will find out how in-line capacitance measurement can produce a detailed fingerprint of cell culture processes and how that can benefit vaccine production. From case studies involving baculovirus, AAV, and measles, you will discover why using capacitance can help determine the optimum harvest time and increase maximum virus concentration to produce more vaccine doses using smaller bioreactors. Finally, you will also learn how you could use capacitance as a key process indicator for improving scale-up success to reduce the costs and timelines of your viral vector and virus-based vaccine production. Fill out the form below to read the complete report and learn more about capacitance measurement now.

Providing consistency in cell culture media biomanufacturing is critical to supply continuity. Central to this is the development of redundancy and harmonization across a global manufacturing network. These unprecedented times have also highlighted the importance of strategizing for increased and unexpected demand. Read this Special Report to learn about the importance of equivalency and the strategies used to maintain this critical requirement at Gibco cell culture media manufacturing facilities. Fill out the form below to read the complete report and learn more about biomanufacturing facilities equivalency now.

Time to clinic and time to market are the key drivers for client success in the biopharmaceutical industry. Facility fit is becoming key to understanding process constraints and which aspects of the process have the largest impact on enabling facility fit. Process development with facility-fit constraints in mind will ensure a smooth technology transfer and shorten the timeline of current good manufacturing practice (CGMP) product delivery to clients. Fill out the form below to read this Special Report and learn more about the role of facility fit in biopharmaceutical process development. 

New chromatography supports must demonstrate improved selectivity, and bead technologies must be optimized for high binding capacity and product recovery. Drug manufacturers also need access to expertise and continued support from chromatography suppliers that can assist with method development and design of experiments (DoE) assessments. Working together, these industry groups can accelerate method development, increase process yield, reduce buffer consumption, minimize the number of unit operations, and improve overall process economies. Learn more in this Special Report about how resin functionalities can maximize yield and improve process economy, helping manufacturers to deliver low-cost biologics to patients with unmet medical needs. Fill out the form below to read the Special Report and learn more about chromatography resin functionalities now.

Advancements in next-generation cell and gene therapies are fulfilling the promise of personalized medicine and attempting to cure and heal patients. Multiple approved products have been launched in global markets and the number of clinical trials continues to grow. Developing innovative advanced therapies is one of the biopharmaceutical industry’s greatest opportunities to dramatically improve patients’ lives. WuXi Advanced Therapies is a contract testing, development, and manufacturing organization (CTDMO) that has launched several innovative world-class platforms. It offers integrated platforms to transform the development, testing, manufacturing, and commercialization of cell, gene, and other advanced biopharmaceuticals. Learn how our innovative solutions can help accelerate time to market and support customer programs around the world. Within this Special Report, we will discuss: Fill out the form below to read this Special Report now.

Single-use technologies enable a flexibility and modularity effectively unattainable with more traditional stainless-steel technologies, particularly in upstream bioprocesses. Single-use bioreactors up to 2,000 L are employed largely in preclinical- and clinical-stage bioprocesses to leverage this flexibility. As products reach commercial maturity, scales larger than 2,000 L frequently become desirable to take advantage of economies of scale. With the typical upper limit of single-use bioreactors at 2,000 L, this has traditionally meant transfer to stainless-steel systems. The introduction of the Thermo Fisher Hyperforma DynaDrive 5,000-L single-use bioreactor opens a new paradigm of operation in terms of volume, while providing unprecedented ergonomics and flexibility. Fill out the form below to read the complete report and learn more about the Hyperforma DynaDrive 5,000-L bioreactors now.