Special Reports

Navigating GMP Manufacturing of mRNA-Lipid Nanoparticles

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…

Simplifying the Route to GMP with a
Risk-Based Approach to Single-Use Implementation

Adopting single-use systems (SUS) is an attractive solution for current challenges within the biopharmaceutical industry. However, before implementing single-use solutions, biomanufacturers must ensure that the required SUS product quality attributes are met. In this special report, subject-matter experts from Sartorius provide insights into SUS implementation strategies for biopharmaceutical manufacturing. Their discussion covers four pillars: forming a regulatory strategy, addressing flexible radiation-sterilization processes, assessing extractables and leachables (E&L), and assuring system integrity and robustness. Then, the writers present a case study…

ADC Development and Manufacturing: Simplify, Derisk, and Accelerate the Timeline

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…

Using Fed-Batch Intensification To Increase Expression Titer During Biologics Manufacturing

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…

Unveiling the Future of Bioprocessing: Cell and Gene Therapy Purification Strategies

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…

Can LC-MS Based PAT Remedy the Pain Points for a Bioprocess Engineer?

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…

Antibody Therapeutic Polishing: Utility of Hydrophobic-Interaction Chromatography

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…

Viral Clearance in the Age of Q5A(R2) and the Case for Using Noninfectious Spiking Agents

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…

Benefits of a Customized Cell Line Development Program

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…

Improving AAV Manufacturing Processes: Using Design of Experiments and Fit-for-Purpose Transfection Reagents

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…