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
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.
Learn about how Efficient-Pro Medium and Feeds elevate productivity in CHO-K1, CHO-S, and DG44 cells for bioproduction in this comprehensive content piece.
Discover how the Gibco™ Efficient-Pro™ system boosts productivity, enhances cell viability, and ensures superior product quality with minimal impurities. Packed with detailed fed-batch study results, this guide offers actionable insights and practical tips to optimize your bioproduction processes, ensuring you achieve higher yields and consistent, high-quality outcomes. Dive into this indispensable asset to elevate your manufacturing workflow to the next level.
In this asset, you will discover how the Gibco Efficient-Pro system can revolutionize your mAb manufacturing workflow. It provides insights into optimizing CHO cell productivity, enhancing product titers and protein quality, streamlining process efficiency, and leveraging a reliable supply network.
Download the white paper and learn how Implementing Real-Time Control of Carbon Dioxide can Impact Productivity at R&D and Production Scale Bioreactors. Dissolved CO₂ is a Critical Process Parameter (CPP) in biopharma production processes, as it has a direct impact on product titer and its critical quality attributes. It influences other culture parameters like extracellular and intracellular pH, as well as key performance indicators such as Viable Cell Density. Uncontrolled dissolved carbon dioxide levels in the bioreactor can result in growth inhibition, lower product titer, and decreased product quality.
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.
