Whitepapers

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.

In this webinar, Eppendorf experts will give an overview of the most used vaccine platforms and discuss the important role of stirred-tank bioreactors in this life-saving field.

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.

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

This ebook gives an overview of the key characteristics of a stirred-tank bioreactor, its different operation modes, as well as the possibilities of scale-up and tech transfer.

This ebook discusses how bioreactors and their components can be employed in cell culture with the goal of increasing process reproducibility.

Traditionally, producing biotherapeutics such as monoclonal antibodies required a multi-step process to remove impurities, including host-cell proteins, DNA, adventitious viruses, and antibody aggregates. However, by converting the process from batch chromatography to multi-column chromatography (MCC), there is potential to reduce costs and shorten production times for the capture and purification of high-quality mAbs.

Transitioning to intensified, continuous chromatography can increase efficiencies and decrease time and cost when analyzing protein A.

Gain access to essential strategies and solutions for optimizing your CHO cell culture workflow. This exclusive resource offers valuable insights and practical guidance tailored to the challenges of scaling up monoclonal antibody manufacturing with CHO cells.

This asset outlines the comprehensive support and guidance offered by the FAS team for optimizing monoclonal antibody (mAb) manufacturing processes using the Efficient-Pro medium and feeds. Readers will learn about the tailored assistance provided at every stage, including troubleshooting, recommendations, ongoing support, site visits, and prioritization of confidentiality.