Whitepapers

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.

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.

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.

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.

As today’s labs continue to evolve, the software solutions that support them must too. Likewise, laboratory and organization leadership must be open to the advancements available to them from modern technologies. In this white paper, learn how a SaaS-based LIMS modernization program optimizes data management, fosters collaboration, and improves decision-making to stay at the forefront of scientific innovation.

Innovation is the engine that powers a company’s growth and product development, and for enterprises with R&D laboratories, those lab environments are the greatest source of this innovation. In this white paper, learn how a platform approach to scientific data management, including semantic search, advanced analytics, and lab automation, leads to better enterprise decisions at the executive level, optimized lab performance, more discoveries, and stronger product pipelines.

Biopharmaceutical companies are increasingly partnering with CDMOs equipped with technologies and expertise to support analytical testing during process development. The level of complexity required to develop and manufacture cell and gene therapies has increased, including the use of various raw materials, custom reagents, and tailored approaches for managing complex diseases.

Charge heterogeneity is present in most biopharmaceutical protein products. During the manufacturing process, charge heterogeneity of the protein therapeutics can occur due to enzymatic cleavage and chemical post-translational modifications (PTM). For therapeutics like ADCs, not only the antibody contributes to the heterogeneity but also the linker and payload, which add even more complexity to the charge variant profiles. Characterizing the charge heterogeneity of ADCs is essential for critical quality attribute (CQA) assessment to ensure drug safety, efficacy, and potency.

Partnering with a CDMO can help streamline drug development, and certain preparations can help ensure a successful collaboration. Scott Alderucci, Curia’s Director of Process Development, explores the advantages of partnering with a CDMO to navigate the journey from molecule conception to clinical trials, including the expertise, experience, and preparedness that a CDMO brings to the table.