Whitepapers

Live-cell imaging enables acquisition of phase contrast images and provides an ideal platform to study multi-faceted biological paradigms in drug discovery. This is vital to our understanding of human diseases and treatment strategies. The movement of these models towards increasingly complex physiologically relevant ones, including patient-derived cells and induced pluripotent stem cells (iPSCs), has concurrently driven the need for label-free methods that are non-perturbing to deliver deeper biological insights.

The response of tumor cells, such as glioblastomas, to cytotoxic chemotherapeutic compounds is a complex and dynamic process that is crucial to understand in neuro-oncology research. Using pre-trained neural networks to accurately segment individual cells and classify them as live or dead is a powerful, robust approach for assessing cytotoxicity in glial cell types.

As the FDA signals stronger support for advancing gene therapy approvals, manufacturers face increasing pressure to get to market quickly while maintaining viral vector quality. This article tackles emerging scale-up challenges to efficiency and safety, with an in-depth look at strategies to optimize viral vector production, manage costs, and collaborate on industry standardization and automation.

Examine the dynamic changes in cell morphology which occur when cells undergo ferroptosis and investigate label-free and fluorescence-based methods of kinetic quantification.

In the rapidly evolving world of cell and gene therapies, innovation is essential if we want to revolutionize medicine. Collaboration in the early stages of development allows us to optimize workflows and apply rigorous quality standards, moving therapies forward without regulatory delays. Our innovative aseptic fluid transfer technologies improve process quality and reduce contamination risks. With a comprehensive global supply network and expert regulatory support from our innovation centers, we help you avoid costly delays and ensure the successful delivery of life-changing therapies.

Scaling up the production of viral vectors, particularly adeno-associated virus (AAV), remains wrought with challenges. The issues of low titer and yield, and vector degradation such as unfolding, aggregation and oxidation, need to be better understood and managed by carefully optimizing buffer, pH and excipients. This article addresses key advancements at each step in the workflow — from maximizing titer output at scale upstream to optimized formulation compositions at fill/finish — to support commercial scale.

Phenotypic screening is a vital tool in drug discovery, enabling scientists to rapidly identify potential drugs early in the discovery pipeline. Kinetic information gained by repeated image acquisition within a physiologically relevant environment provides insight into the dynamic changes which are often overlooked using end-point analysis alone.

This application note demonstrates the feasibility of an efficient and scalable AAV production platform, using a suspension-adapted HEK293 cell line (Expi293F) as the host.

Novel fields, such as cell and gene therapy require large amounts of cells to be produced and are therefore dependent on efficient scale‐up, the process of increasing bioprocess dimensions. However, as multiple parameters are influenced during this process, it is not easy to keep yields consistent between small‐ and large‐scale approaches. Therefore, in order to design the scale‐up process as efficient as possible, different strategies focusing on different parameters were established over time. In this ebook, Eppendorf thought leaders will give an overview of the current gold standards in scale‐up and share their opinions on advantages and disadvantages of different strategies. Furthermore, scale‐up of both bacterial and mammalian cell culture is experimentally demonstrated in this publication.

Bioreactors have become an industry backbone for growing vast amounts of cells to produce therapeutic agents, as the process involves a precise balance between nutrient availability, temperature control and oxygen/carbon dioxide balance, among other parameters which all must be closely monitored. Learn in this ebook about recent advances in bioprocessing for biologics and gene therapy vectors.

Process validation is essential in biopharmaceutical drug production to ensure product consistency, safety, and quality at every clinical stage, and to effectively reach commercial approval. It minimizes risks, reduces costs, and facilitates a smoother transition from earlier clinical stages to large-scale production, ensuring that drugs are made efficiently safe and effective for patients.

Harmonizing technological innovation and a platform approach in biomanufacturing can reduce time and cost barriers to produce stable, high-expressing antibody-based therapeutics.

By integrating QbD into the development process, organizations can achieve robust manufacturing processes, regulatory compliance, and commercial success.

This technical overview compares the characterization of NISTmAb using the ProteoAnalyzer with published NIST data obtained via traditional single capillary CE-SDS technology. The results show strong correlation with the reference data, confirming that the ProteoAnalyzer is a reliable tool for analytical workflows.

Ecolab is looking to the future with new opportunities to partner with Pharma for critical solutions to support drug development and manufacturing.

Dr. Tim Sandle's SmartNote series discusses how a risk-based approach to environmental monitoring helps facilities maintain control over their environment and supports quality assurance efforts. Plus, they highlight the importance of selecting appropriate monitoring locations and taking proactive measures based on monitoring results to ensure consistent environmental quality and mitigate potential risks to product safety and integrity. 

Increasing mRNA yields using CleanCap® M6 pulse-feed protocol. This technical note reviews the in vitro transcription (IVT) kinetics of CleanCap M6, including those associated with a supplementary pulse-feed protocol to increase IVT yields and help lower the costs associated with mRNA manufacturing.

Explore how an integrated, single platform imaged capillary isoelectric focusing (icIEF)-UV/MS workflow with the Intabio ZT system aims to tackle the challenge of charge heterogeneity profiling with a disruptive strategy that allows for separation, quantitation, and identification of individual charge variants to be achieved in minutes on a single platform.

Developing successful oral solid dosage forms necessitates partnering with a CDMO equipped with distinctive technologies and expertise to enable support across solid-state characterization, formulation development and scale-up manufacturing processes.

Due to their ability to tackle targets that were considered undruggable, oligonucleotides represent a key cornerstone of the future of personalized medicine. This infographic presents the different types of therapeutic oligonucleotides and highlights some innovative solutions for their analysis.

Learn about the typical state-of-the-art setup for high-throughput peptide mapping using chromatography and mass spectrometry (MS) techniques, as well as ways of simplifying mapping data.

This application note provides an in-depth look at the batch, fed-batch, and perfusion bioreactor operation modes using the commonly employed CHO cell line as an example.

Whether you are new or experienced in bioprocessing, this website arms you with useful knowledge from general bioprocessing topics to expert advice.

This white paper addresses the distinct steps in the plasmid production workflow and provides advice on microbial process optimization to increase yields