In order to enhance access to life-saving medicines, the biopharmaceutical industry must prioritize more efficient therapeutic production. However, the environmental impact of manufacturing choices is facing increasing scrutiny. Sustainability opportunities within the biopharmaceutical sector encompass reducing the environmental footprint, addressing resource depletion, and effectively managing waste through repurposing and recycling. During a recent panel discussion, sustainability experts from Sartorius and their collaborators shared valuable insights on enhancing the sustainability of manufacturing processes. These insights encompass adopting single-use technologies, improving process efficiency, and fostering productive collaborations. This Special Report offers extracts from those enlightening discussions, along with relevant excerpts from Sartorius' white paper on sustainability in the biopharmaceutical industry.
Over the past few years, there has been rapid progression and commercialization of mRNA vaccines and therapeutics, in large part due to the emergence of COVID-19. The lipid nanoparticle (LNP) technology underpinning this new drug modality enabled biopharmaceutical companies to adapt existing knowledge and processes developed for other applications to create vaccines within an accelerated timeline. However, navigating the regulatory and manufacturing landscape surrounding these developments has not been without its challenges. In this new Special Report, gain insights into opportunities, challenges, and strategies for success, including:
Antibody–drug conjugates (ADCs) are complex therapeutics that offer a unique combination of selectivity and potency. Commercial demand for ADC therapeutics is projected to continue to increase while facing a very complex development, manufacturing, and supply chains challenges. Given the complexities of ADC development and manufacturing, there are clear advantages to partnering with a single contract development and manufacturing organization (CDMO) that offers a complete set of services. As ADCs continue to grab a larger share of clinical pipelines, it becomes increasingly essential to select a CDMO partner with the experience and expertise to accelerate timelines while minimizing risk. Fill out the form below to read this special report and learn more about ADC market, growth, challenges, and solutions to accelerate ADC pipelines to market.
Improving manufacturing productivity is a major goal in today’s biopharmaceutical industry, especially as new and increasingly complex molecules are fundamentally changing technological and operational approaches to drug development. Process intensification can accelerate the pace of innovation by introducing advanced process-development techniques and high-productivity manufacturing platforms. N – 1 perfusion represents a promising strategy for increasing the density of cells that are used to inoculate fed-batch cultures in production-scale ( N -stage) bioreactors ultimately increasing product accumulation within a production bioreactor. In this special report, Ruth Rowland-Jones describes Lonza’s achievement to establish a platform process for high inoculum density (HID) fed-batch culture of Chinese hamster ovary (CHO) cells. Such efforts included implementation of advanced process analytical technologies (PATs) including capacitance probes and Raman spectroscopy for automated monitoring and adjustmen...
Discover the cutting-edge advancements in bioprocess intensification and cell & gene therapy purification with this comprehensive custom report from Astrea Bioseparations. Explore the latest innovations and breakthroughs that promise to revolutionize the field. HCPure™ Host Cell Protein Clearance Resin: Bioprocess Intensification through Mixed-Mode Chromatography Delve into the world of mixed-mode chromatography and how HCPure™ Host Cell Protein Clearance Resin is transforming bioprocess intensification. Learn how this technology is enhancing purification efficiency and streamlining biomanufacturing. Enhanced Efficiency in Cell & Gene Therapy: The Role of Plasmid DNA Purification Uncover the critical role of plasmid DNA purification in improving the efficiency of cell and gene therapy production. Explore the latest techniques and strategies that enable more efficient and reliable purification processes. Scalable Downstream Purification with Lenti HERO®: Safeguarding Lentiviral Vector Yield Expressed by A...
The past decades have brought a tremendous increase in new biologics and biotherapeutics that offer patients more efficient and safer treatment options than they had before. Such revolutionary innovations in biopharmaceuticals are to a large extent thanks to advancements in upstream research and development, which are important drivers of bioprocesses. But despite this unceasing progress, upstream bioprocess engineers continue to face challenges and pain points in their work. In this article, Magnus Wetterhall, Global Marketing Manager — Bioprocess at Waters Corporation, highlights some of those pain points with a view to how comprehensive process analytical technologies (PATs) based on liquid chromatography (LC) and mass spectrometry (MS) can help to address such issues in development and manufacturing of new biotherapeutics. Fill out the form below to read the full report now.
The ultimate goal of downstream purification is to reliably and predictably produce a safe drug product suitable for therapeutic use in humans. To this end, biomanufacturing process- and product-related impurities such as host cell proteins (HCPs), residual DNA, leached protein A, process leachables and extractables, adventitious and endogenous viruses, endotoxins, antibody aggregates, and other antibody variants all must be removed to acceptable levels in conformance with regulatory guidelines. Downstream processing of traditional therapeutic monoclonal antibodies (MAbs) has become relatively standardized with an affinity capture step followed by various polishing steps as needed. For novel engineered therapeutic antibody formats, the standardized platform may be suboptimal, and process development scientists can use various chromatographic tools to improve recovery and purity in both the affinity and polishing steps. Depending on a specific residual impurity profile and process challenges, an anion-exch...
As viruses can arise during the manufacture of biopharmaceuticals, regulatory agencies require “viral clearance” validation studies for each biopharmaceutical prior to approval. For example, Type C Retrovirus-Like Particles (RVLP) are endogenously produced during CHO cell expression. As such, regulatory agencies require proof that downstream process steps can effectively remove or inactivate retrovirus. A model mammalian virus, Xenotropic Murine Leukemia Virus (XMuLV) is typically used to demonstrate RVLP clearance. However, the establishment of RVLP quantification methods has made it possible to track the removal of actual endogenous RVLP throughout the downstream process. Additionally, the recent draft of ICH Q5A revision states that, “For CHO cell-derived products, CHO-derived endogenous virus particles (RVLP) can also be used for viral clearance experiments.” In this Special Report, you will learn more about the use of a BSL-1 compatible, non-infectious RVLP and MVM particles to predict viral clearanc...
Cell line development at Just-Evotec Biologics is focused on lowering the cost of manufacturing and creating highly productive cell lines for our clients and partners. To achieve this, we leverage our own in-house GS knockout CHO host cell line, which has been shown to support cell densities up to 80 M cell/mL and productivities upwards of 5 g/L/day in our perfusion bioreactor platform. Additionally, we have implemented advanced instruments and liquid handling automation to increase the throughput of processes that are historically major bottlenecks. Examples of this include semi-automated, independent transfections of up to 32 different expression vectors or high throughput single-cell cloning/screening of up 1000 clones. Paired with our process development and manufacturing expertise, we continue to push the envelope on improving drug costs and have enabled many of our clients to file for BLAs. Fill out the form below to read the full special report from Just-Evotec Biologics.
When evaluating a new process for viral vector manufacturing, you may be wondering what the best path forward is to save time and resources while ensuring to produce enough data to support the robustness of your future manufacturing and scale-up. Polyplus ® free of charge DoE service is the combination of our expertise in the field of nucleic acid delivery and in DoE methodology to support you through the evaluation of our transfection reagents. As each process is different, this service helps to choose optimal conditions for transfection experiments with Polyplus ® FectoVIR ® -LV, FectoVIR ® -AAV and PEIpro ® transfection reagents. We aim to help you cut down time and cost of process development to decrease cost per dose of treatment and improve patient access to ATMPs. Fill out the form below to download the full report now.
In October 2022, a new draft of ICH Q5A (R2) was released, the first such update in more than 20 years. This draft revision was necessary to reflect current scientific knowledge and biotechnology advances such as new product types that are amenable to viral clearance and alternative virus clearance validation strategies. In this report, we delve into the evolving landscape of viral clearance practices, focusing on the implementation of continuous manufacturing, advancements in study design, and the implications for cell and gene therapy products.  Additional topics discussed include the vital role of detergent treatment, low pH treatment, and viral filtration in shaping the future of viral clearance. Stay ahead of the curve. Sign up today and prepare yourself, and your team, for the next frontier in viral clearance. Fill out the form below to read the special report from Charles River now.
In order to enhance access to life-saving medicines, the biopharmaceutical industry must prioritize more efficient therapeutic production. However, the environmental impact of manufacturing choices is facing increasing scrutiny. Sustainability opportunities within the biopharmaceutical sector encompass reducing the environmental footprint, addressing resource depletion, and effectively managing waste through repurposing and recycling. During a recent panel discussion, sustainability experts from Sartorius and their collaborators shared valuable insights on enhancing the sustainability of manufacturing processes. These insights encompass adopting single-use technologies, improving process efficiency, and fostering productive collaborations. This Special Report offers extracts from those enlightening discussions, along with relevant excerpts from Sartorius’ white paper on sustainability in the biopharmaceutical industry. Fill out the form below to read the full report from Sartorius now.
Market experts recommend automated filling systems for drug developers seeking to reach the next level in drug-substance management. Many companies are starting automation initiatives, which suggests an overall trend towards automated filling. The stakes are high. Increased process deviation in fluid management can lead to increased loss of valuable biopharmaceutical products. Automated and standardized aliquoting of biopharmaceutical drug substances into single-use bioprocess containers simplifies the manufacturing process while improving throughput, speed, and filling accuracy. Fill out the form below to read the full report now.
In this report, Avid shares its approach to producing high-quality, safe, and effective viral vectors for use in gene therapy and vaccine applications. The company is dedicated to minimizing the risks for, and associated high costs of cross-contamination and contamination during manufacture of viral-vector products. To this end, the contract development and manufacturing organization (CDMO) is establishing a rigorous quality control program as it completes its new facility. In 2021, Avid began building a 53,000-ft 2 site in Costa Mesa, CA, close to its main campus in Tustin, CA. The process development (PD) and analytical development laboratories were completed in 2022, and the good manufacturing practice (GMP) facility is expected to be ready in mid-2023. The author summarizes how Avid designed engineering and quality controls to provide several layers of protection. He describes use of LoPA (layers of protection analysis) as a major tool in Avid’s risk-assessment toolbox. That enables the company to co...
There’s no doubt that CHO cell lines are being pushed to their limits: While advancements are being made, little has been done to characterize the physical stability of secreted antibodies from their inception during CHO cell line development. Scientists have been forced to stabilize biologics that were not designed with aggregation in mind from the ground up, often with limited success. But that’s about to change. Aura™ immunoassays with particle characterization bridge the gap between cell line development and developability to enable, for the first time, pre-screening for antibody stability once MAbs are secreted from CHO cells. Aura systems enable quick characterization of unfiltered cell lines samples through low-volume, high-throughput imaging, counting, sizing, and identification. Analyzing biologically complex cellular and protein samples present in CLD to characterize secreted protein stability has never been faster or more accurate. Aura PTx can quickly and accurately characterize secreted antib...
The rapid advancement and competitive environment of the modern biopharmaceutical industry, accompanied by the need for continuous quality improvement, demand robust analytical instruments. Analytical technology is one key factor contributing to the quality and safety of finished products. Ongoing improvements in analytical instruments are needed to address new challenges, including specificity of target substances, high complexity of matrices, and multiple production stages with a number of input and output parameters and peculiarities. Those factors point to the demand for a versatile solution, one that can be used accurately and reliably for analyses of intermediate Ultraviolet-visible (UV-vis) instruments constitute a large portion of the analytical tool set currently used in the biopharmaceutical industry, although most traditional UV-vis technologies have a narrow detection range that can limit functionality in direct applications. Because the light absorbance value in UV-vis is directly proportiona...
Scientific advances have increased the safety and efficacy of recombinant viral-vector technology for cell and gene therapies. In this special report, we will discuss how tailored transfection reagents improve the scalability of AAV and lentivirus production. We will also focus on the challenges of scaling up viral vector production platforms and the importance of selecting the right transfection reagent for this process to increase the titer and quality of viral production to generate more therapeutic doses per run. Fill out the form below to read the full report from Mirus Bio.
Due to their numerous benefits, single-use systems (SUS) have been increasingly implemented in biopharmaceutical processes in the past decades. Originally used in applications for the preparation and storage of buffer and media, SUS have become more and more important in the commercial production of biopharmaceuticals. Today, biopharmaceutical manufacturers use this technology in critical drug substance or drug product process steps such as formulation, bulk storage, bulk transport, and final filling of drug product. By using single-use technologies, manufacturers can reduce costs, increase their manufacturing flexibility and options for closed processing. Especially through the COVID pandemic, we learned that single-use solutions can enhance speed and flexibility. Nevertheless, despite all their advantages, there are still some risks associated to SUS, such as potential leakages during use. Read now: Ensuring Single-use Systems Integrity in Aseptic or Closed-Process Applications .
After launching Nereus LentiHERO, a game changing fit-for-purpose solution for lentiviral vector purification in 2022, Astrea Bioseparations present this end of year report with a selection of interviews, application notes, and articles. Identifying the gaps in lentiviral purification, they discuss how to increase processing efficiency, purity, and recovery of LVV particles. They also look towards the future to bring a radical change in bioprocessing for cell and gene therapies. The Nereus LentiHERO spin column is the first product in a family of next generation purification devices leveraging nanofiber technology. Stay tuned for more product releases in 2023, reducing bottlenecks, and supporting you to become the hero! Fill out the form below to read the full report from Astrea Bioseparations now.
Today’s drug manufacturers are faced with the need to find efficiencies across a wider range of modalities than ever before, even as gaps in technology still exist. The economics of the process includes cost and time and must also consider quality and reproducibility. Working with suppliers that understand the full scope of drug development and commercialization challenges, and provide reliable, scalable solutions tailored to each unique process is critical to success. In this special report, the team from Polyplus reintroduces the company and offers a look into a legacy of innovation that is evolving into a new approach to optimizing process economics across modalities. Fill out the form below to read the full report from Polyplus below.
Multichain protein biotherapeutics such as bispecific molecules have been developed to treat cancer, neurological and ophthalmic disorders, and autoimmune and inflammatory diseases. Early successes now are driving greater numbers of such molecules toward clinical evaluation and commercial approval. However, the complexity of bispecific development and manufacture calls for innovative tools and technologies to facilitate the clinical journeys of such products and prevent costly setbacks for their sponsors. In its commitment to fostering novel biomolecular formats, Lonza has designed a chemistry, manufacturing, and controls (CMC) strategy for bispecific molecules that can enable delivery of a data package for submission of an investigational new drug (IND) application within 13 months of DNA transfection. This strategy provides customers with a comprehensive DNA-to-IND offering with reliable timelines backed by Lonza’s decades of experience in biologics and by investment in cutting edge technology, which re...
Robust and precise chromatographic analytical methods are key for the efficient development of the mRNA production process. Three different analytical methods, which utilize three different column chemistries, are embedded in a ready-to-use PATfix™ HPLC analytical platform to support mRNA process development and product quantification and characterization. Fill out the form below to download the full report from BIA Separations, now a Sartorius Company.
Reduction of Host Cell Proteins (HCPs) to the lowest levels practical requires sensitive and robust analytical methods. In this Special Report, Cygnus Technologies discusses industry best practices for HCP analysis and integration of orthogonal methods for in-depth HCP characterization using Antibody Affinity Extraction (AAE) and Mass Spectrometry (MS). Download the report to learn about: Fill out the form below to download the full report from Cygnus Technologies now.
When choosing a container for critical drug substances, the material of construction should be your first consideration. It is arguably the most important indicator of container success. Fluoropolymer containers such as Purillex bottles are an excellent choice for BDS storage, freezing, and shipment because of their proven physical and performance advantages. This special report outlines robustness testing of fluoropolymer BDS containers focusing on extractables and leachables, container–closure integrity, durability, gas permeability, and performance during freezing and thawing. Fill out the form below to download the full report from Savillex.
Throughout evolution, viruses have developed mechanisms to interact with and manipulate the genetic material of their target cells. As a result, modern virology uses a growing number of applications to understand these agents of disease. Such applications range from transfection of cells for genetic manipulation to medical studies with a strategic focus on developing novel vaccines, treatments, and gene therapies. Assessment of virus type and content is also important for ensuring food and drinking water safety as well as for surveillance of pathogens and disease outbreaks. Fill out the form below to read the full report from Sartorius.
Gene therapies that use AAVs have shown great promise, but can be unstable due to their fragile composite DNA/protein nature, which presents an analytical challenge when determining root cause of subvisible particle (SVP) formation and product instability. Understanding how these proteins interact with leaked payloads will allow better insight into avoiding aggregate buildup. Yet, this has been difficult, hampered by legacy systems that cannot conduct low volume SVP analysis or interrogate for DNA content. That’s about to change. In one 5µL assay, Aura GT can quantify capsid aggregates, distinguish them from protein aggregates, and detect DNA leakage from unstable AAV capsids. Powered by Fluorescence Membrane Microscopy, helps monitor nucleic acid leakage that can occur under common storage conditions which often leads to AAV aggregation. Aura GT provides a low-volume, high-throughput, and sensitive methodology for comprehensive AAV formulation development, enabling characterization of subvisible particle...
Bispecific antibodies (bsAbs) have transformed the field of immunotherapy. However, moving these life-changing therapeutics from the bench to the clinic can be time-consuming and costly. Further, challenges such as aggregation, degradation, fragmentation, and denaturation may ultimately hinder a program from advancing to the clinic. Partnering with a CDMO with relevant experience and technologies can be critical for safely and cost-effectively manufacturing bispecific antibodies. With Selexis’s cell line technology and KBI Biopharma’s manufacturing and analytics, we lead the industry in technologies and expertise for efficiently producing bispecific therapeutics for clinical use. The promise of this class of therapeutics is huge, and we are driven to help our clients rapidly advance the clinical development of these new and powerful treatment options for patients who live with cancers and other serious diseases. Just fill out the form below to read the full report.
The Avid project management office employed unique technology and communication techniques to maintain business continuity and material supply to our partners and the patients they serve throughout each COVID surges. The presentation will take a deep dive into the challenges and solutions encountered for each functional area in the biologics development and production process during the early COVID pandemic and later surges. Ultimately, discussing the lessons learned to maintain both internal and partner engagement during challenging times. Fill out the form below to download the full report from Avid Bioservices, Inc.
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.