Whitepapers

Metabolic Flux Analysis (MFA) is a powerful technique used to characterize metabolic phenotype driving to improved productivity in biomanufacturing. MFA is most powerful when absolute concentrations of the metabolic intermediates are measured, but doing so in practice is often impractical due to inherent limitations of conventional absolute quantitation by mass spectral analysis. Recently, advances in artificial intelligence (AI) have been applied to solving the problem of broad, untargeted, absolute quantitation in liquid chromatography-mass spectrometry (LC-MS). These new approaches extend readily to the determination of absolute concentrations of stable isotopically-labeled metabolic intermediates, offering a new tool for MFA. Dr Sam Yenne from Metalytics Inc., a company that specializes in the science of metabolic flux, has recently assessed and adopted Pyxis, a new tool for absolute quantitation of raw LC-MS data. Dr Yenne describes MFA, its utility in biopharmaceutical development, associated challenges and how Pyxis impacts those challenges.

NGS-Based Viral Safety Testing for ATMPs: Mandatory or Just an Option?

Characterization and Release Testing for AAV Therapies – the Importance of Empty/Partial/Full Capsid Analysis and its Impact on Potency

Learn highlights from the 2024 event, including new strategies for viral clearance and NGS applications for viral safety testing.

Cell banking and cell line characterization experts are sharing why HEK293 cells are important for viral vector production for CGT products.

Your biologic can only be as successful as the cells behind them. Learn about our full spectrum of CGMP cell banking and cell line characterization services.

When complexities of developing donor-derived cell therapies are considered, NGS emerges clearly as a better, cost-effective yet regulatory-compliant solution.

Download Part 2 of the DCO₂ White Paper Series and learn the shortcomings of current measurement technologies. As demonstrated in Part 1, Dissolved CO₂ is a Critical Process Parameter (CPP) in biopharma production processes. However, the sensors currently used to measure and monitor this CPP each have significant drawbacks.

Download our comprehensive white paper and gain valuable insights into the critical process parameters and advance sensor technologies that can revolutionize your Biopharma Downstream Process (DSP). Discover strategies and techniques to optimize efficiency, improve product quality, and ensure the safety and efficacy of your biopharmaceutical products.

How does PAT apply to the bioreactor? Download our comprehensive white paper and explore what PAT means in Biopharma Upstream processes. Discover cutting-edge solutions to effectively monitor critical process parameters and ensure product quality.

Are you missing sources of measurement error? Measurement of dissolved oxygen (DO) has long been known as a critical control parameter for optimizing cell growth in bioprocesses. Much has been written about different strategies for proper DO control. However, little information has been publicly available regarding optimization of the actual measurement accuracy and reducing common sources of process-related error. Our White Paper aims to divulge these details for the first time.

Collect More Actionable Data and Optimize Yield with Real-Time Process Adjustments. Learn more how Viable Cell Density Monitoring works for your process in Hamilton’s eBook that features must-see examples of real applications using Hamilton viable cell density monitoring (Incyte) and total cell density monitoring (Dencytee).

Cell-based assays (CBAs) are key tools for evaluating the potency of new biologic drugs. Catalent’s transcription-based bioassay simplifies and empowers the testing of new biologics.

Discover how our latest study demonstrates consistent performance across 250mL and 5L bioreactors, ensuring reliable results at any scale. Dive deeper into optimizing your gene therapy processes with scalable, data-driven solutions.

Adeno-associated virus (AAV) is a critical vector in gene therapy, but process robustness and scalability can pose challenges. This whitepaper demonstrates how Culture Biosciences' on-demand fleets of 250mL bioreactors enable large-scale experimentation and real-time data access to optimize upstream processes. Learn how process optimization can increase the fraction of full AAV capsids, accelerating your path to market.

This whitepaper explores how Culture Biosciences' cloud-connected 250mL and 5L bioreactors provide high-fidelity, continuous data streams to deliver accurate cell growth metrics. Learn how automated data analysis and real-time monitoring of key performance metrics like doubling time and production rate enable rapid bioprocess insights.

Culture Biosciences provides cloud-enabled 250mL bioreactors designed for various applications, including mammalian cell cultivation. Accurate transfer of process setpoints is critical to ensuring the success of moving client processes from other systems to Culture’s bioreactors. This whitepaper presents a detailed characterization study of Culture’s mammalian cell bioreactors, highlighting the precision and consistency achieved during process transfer.

This whitepaper explores how power analysis can help determine the optimal sample size for statistically powered clone screening experiments in bioreactors. Learn how to improve key performance indicators such as titer, rate, and yield while accounting for bioprocess variability.

To help provide patients with greater access to safe, effective biological products, the FDA approves biosimilars on an abbreviated pathway. How should you work with the FDA to navigate this pathway?

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.