Whitepapers

Maintaining a supply of high-quality product for patients is reliant on the accuracy and completeness of data generated during the development and manufacturing process. Data integrity is critical to ensure that the electronic and paper records we archive and the information they contain retain evidence of the quality of the work performed. This talk discusses data integrity, what it is, and how to implement a robust data integrity program.

Our journey from compliance to quality is rooted in deep traditions, but are those traditions helping us or hurting us? Focusing solely on inspecting for compliance is not sufficient to prevent drug shortages nor ensure drug quality. This talk discusses the quality management maturity (QMM) model, how to move to a culture of quality, common areas of improvement, what to expect.

For an organization to move to and thrive in a culture of quality involves having consistent, reliable, robust business processes and data that promote continual improvement and deliver on quality objectives. This webinar considers some of the most important aspect of quality management, including techniques to achieve a modern maturity model (QMM). We discuss potential areas of improvement, such as a patient-centricity focus, the accuracy and completeness of data, and how to meet current and future regulatory requirements.

A key element of a biosimilar program includes building a development plan to demonstrate comparability between the proposed product and the selected reference product. What steps should be taken to prepare?

This whitepaper explores the importance of safe cGMP pharma product storage, highlighting challenges CDMOs face with inventory bottlenecks and delays. It examines off-site cGMP storage benefits, including cost savings, flexibility, and compliance, while addressing key factors for maintaining product safety and accessibility.

The nexus between biopharmaceuticals and sustainability is seemingly far apart, however, it is increasingly recognized as an inevitable challenge. It is encouraged to take a sustainable approach to reducing the environmental impact of the production and supply of medicines while improving people's health; delivering the well-being of people and the planet. Yosuke Shimojo (Technical Value Support Section Manager, Nagase Viita) will unveil how SOLBIOTE™, a portfolio of injectable-grade saccharide excipients, would be a key for the biopharmaceutical development and achieving sustainability for a better future of the industry.

Compendial testing covers a wide array of materials, subjects, and locations designed to create standards and programs that ensure the quality and safety of approved articles for a geographical location or areas such as USP (For the United States market) or Ph Eur (For European markets). The compendia provide monographs and test methods for active ingredients, raw materials, drug products, utilities (water and gases), and packaging components.

In this rapidly changing environment, your choice of CDMO partner is critical. The right partnership can serve as your key to commercial success, while the wrong one can lead to costly delays, quality issues and compliance risks. To help you overcome your OSD challenges and drug product manufacturing challenges and streamline your journey to commercialization, our experts have developed an eBook to help you find the right CDMO for your project.

Elemental impurity testing is essential to deliver safe drug products to patients and is a regulatory requirement. It is important to assess the risk of elemental impurities from all sources in the manufacturing process, including process equipment, water, container/packaging, raw materials, drug substances, and the final drug product.

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.

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.

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.