Sponsored Content

Gyrolab Immunoassays: Streamlining Workflows Through Automation

Immunoassays and other types of ligand-binding assays are widely used in the development of monoclonal antibody (mAb) therapeutics to measure antibody titers and support downstream purification processes by tracking impurities such as host cell proteins (HCPs) and leakage of protein A from affinity chromatography columns. While scaled down bioprocess development models and high-throughput testing generate large numbers of samples for analysis, immunoassays remain largely manual in many companies, resulting in high assay variability and low productivity. In contrast, automated immunoassays…

Automated, Closed-Loop, Inline Monitoring of CAR-T Cells in a Production Process

This webcast features: Jan Van Hauwermeiren, VP Sales and Marketing, Ovizio Imaging Systems Cell-based technology is a fundamental pillar of modern biotechnology. With the development of cell therapy products (CTPs), there is an increased need for robust and validated measurements for cell characterization to enable manufacturing control and a safe, high-quality product released to the patients. Our company has developed an inline, automated microscope that generates reliable viable cell counts (VCCs) without the need for active sampling, in real time…

Streamlining the Antibody Discovery Workflow at ModiQuest Research

With breakthroughs in molecular engineering and antibody humanization, monoclonal antibodies (mAbs) are one of the fastest-growing classes of biopharmaceuticals for most clinical indications. In 2017, 10 therapeutic monoclonal antibodies were approved in the EU or US with nine additional candidates under regulatory review and 60 in phase III clinical trials 1. mAbs are the backbone of many treatment modalities including unconjugated therapeutic antibodies, antibody drug conjugates, bispecific antibodies and CAR-T cell therapy. Many of the approved antibody drugs engage the…

GMP Flow Cytometry: Applications, Considerations and Challenges

This webcast features: Jamie Hall, Project Manager, Center of Excellence for Biopharmaceuticals, Intertek Pharmaceutical Services Flow cytometry is a powerful technique which can be applied to all stages of the drug development pipeline including discovery, clinical development, CMC, regulatory submission and in support of production. It allows the analysis of complex mixtures of particles, from polystyrene beads to cells. Utilizing a broad spectrum of fluorescent detectors, assays can be set up to assess multiple parameters at once and ascertain otherwise…

China’s Emergence in Global Biopharma Manufacturing: Trends in the Chinese Biopharma Industry

This four-part educational series, sponsored by BioProcess International and BioPlan Associates, Inc., highlights key trends emerging in China biopharmaceuticals, using select content BioPlan Associates’ 2018 2nd edition report, Advances in Biopharmaceutical Technology in China, 2nd Ed. The quarterly series, each consisting of articles, an e-book, 40-min webcast, and live presentation at select BPI Events cover China’s Emergence in Global Biopharma Manufacturing: Trends in Chinese Biopharma Industry. The projects include an Overview, Developments in Biologics, Biosimilars, and Global Expansion. The series…

China’s GMP Strategies: Dealing with Quality Management Issues, to Compete with the West

This webcast features: Dr. Fai Poon, President, Quacell Biotech Ltd. China’s biopharma sector faces multiple challenges in quality management, including lack of experience and talent, a rapidly changing regulatory environment, as well as cultural issues in management. In Part 3 of our series Fai Poon, President, QuaCell Biotech, Ltd., will cover China regulatory issues, a review of current challenges in biopharma quality management in China, and opportunities for progress in this field with the growing CMO platforms and the emerging…

Rapid Process Optimization with Customizable Single-Use Bioreactors: The Bioreactor That Adapts to Your Bioprocess

To enhance their performance, life science specialists require flexibility in their work and tools. The increasing diversity of bioprocess applications calls for different cultivation methods. Therefore, being able to customize processes and equipment is a significant advantage. With over 45 years of experience in customizable multi-use bioreactors, Applikon Biotechnology now provides the same flexibility with customizable single-use bioreactors. The AppliFlex ST bioreactor is a fully configurable, stirred-tank, single-use bioreactor that can be designed to specific customer demands. Using three-dimensional (3D)…

Advancing Robust Manufacture of T-Cell Therapies: Application of Single-Use Stir-Tank Bioreactors

With the increase of T-cell immunotherapy research, cell therapy developers have encountered the difficulty of producing consistent, high-quality products. Approved therapies Kymriah™ (tisagenlecleucel, Novartis), Yescarta™ (axicabtagene ciloleucel, Kite Pharma), and late-phase clinical products BB2121 and UCART19 have been critiqued for presenting potential obstacles to patient access because of high costs of treatment and variable manufacturing outcomes. Manufacturing processes need to be developed to increase control over each unit step in a way that improves product consistency over the life of…

Eppendorf BioBLU® 10c Single-Use Vessels Simplify Handling of Cell Culture Bioprocesses at Bench Scale

Substituting traditional glass bioreactors with single-use equipment can simplify a bioprocess workflow. Implementing single-use vessels eliminates the need for cleaning and autoclaving, thus reducing the time needed to prepare a bioprocess run and lowering contamination risk. Another advantage is that single-use vessels reduce occupational hazards associated with overweight handling (especially at larger bench scales) because plastic weighs less than glass. Fill out the form below to read the complete white paper now.

Updating Biologics Manufacturing: Using Modern, Single-Use Powder Handling Reduces Time to Market and the Chance of Contamination

Biopharmaceutical companies are striving to produce biologics more efficiently with a lower cost point and fewer employees. Most small-scale media and buffer operations are carried out with small bottles of liquid media. But as processes are scaled up to manufacturing levels, that is no longer a viable option. Costs of shipping liquid are simply prohibitive, so the industry has migrated to using media and buffers in powder form. In fact, 90% of cell culture media and buffers for sale is…