Case Studies & Customer Stories

Elevating Downstream Process Development with Real-Time Data Monitoring

The Challenge — Improving process understanding directly correlates with better control, potentially reducing deviations, aiding in root cause identification, and ultimately making therapeutics safer for patients. The Quality by Design (QbD) framework encourages building in quality into the process design. Process Analytical Technology (PAT), can help us achieve this by providing a method of monitoring a process in real time—either in-line or on-line—particularly focusing on critical process parameters (CPPs) that are essential for controlling critical quality attributes (CQAs).

Improving Turnaround Time and Efficiency in Microbial Identification

The Challenge — Traditional microbial identification methods can be time-consuming, hindering a swift response to contamination events. AGC Biologics implemented the use of a MALDI Biotyper^® to identify microbes almost instantaneously in-house, reducing the chance of delays caused by any events to help ensure timelines and lot dispositions are kept on track.

Predicting Viral Clearance Early with MockV

The Challenge — Generally viral reduction studies occur late in the development process after the manufacturing process has been scaled up, limiting opportunities for further process optimization and bringing an additional cost to developers. AGC Biologics recognized the need for additional preliminary data to enable selection of specific downstream steps and process parameters to test and can reduce the overall cost of the typical studies performed at this stage.

Early Stability Evaluation Accelerates CLD Timelines

The Challenge — Traditionally, selecting a stable cell line takes over 12 weeks to complete, involving extensive stability studies to ensure that the chosen clone maintains consistent productivity over time. This lengthy process exposes the project to the risk of instabilities, potentially delaying production and increasing costs. AGC Biologics developed predictive stability study to speed up cell line selection.

Solving HCP Co-Elution Issues with Cell Line Engineering

The Challenge — During cell line development for a therapeutic protein, AGC Biologics found that a CHO host cell protein was bound to and co-eluted with the product. Host cell engineering removed a host cell impurity, eliminating customized downstream purification, simplifying the process, and reducing costs.

Reducing Costs in Biologics Manufacturing with a Fed-Batch Approach

The Challenge — A biopharmaceutical client faced significant challenges in scaling up production to meet commercial demands. While their initial small-scale manufacturing process utilizing perfusion technology proved effective, the company recognized the need for a more efficient and scalable manufacturing strategy to ensure the successful commercialization of their therapeutic protein. Learn how AGC Biologics crafted a strategy to enhance productivity and significantly reduce costs, making the drug more accessible to patients.

Streamlining Antibody Capture with Multi-Column Chromatography

The Challenge — Traditional batch chromatography, while widely used, presents limitations such as high resin costs, underutilization of resin capacity, and a less-than-ideal footprint. These challenges can significantly impact the development and production of new therapies, especially for small to medium-sized biotech companies.

Robust, Scalable Manufacturing

N-Linked Glycan Analysis for Complex Glycoproteins

The Challenge — The client had an established cell line and process for a complex glycoprotein that produced high-quality material but had a low yield and was not scalable. With plans to move into clinical development, AGC Biologics was challenged to develop a robust, scalable manufacturing process for this molecule while addressing the unique project parameters and production requirements. 

Get Your Antibody Produced on Time

The Challenge — Accelerating the development and manufacture of monoclonal antibodies is critical for reducing the time it takes to move a promising therapy from bench to clinic. Learn how AGC Biologics can deliver the needed quantities of cGMP monoclonal antibodies within your deadlines.