Upstream

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…

The Challenge of Building Better, Lower Cost Biologic Drugs Faster

A critical factor for both the lowering in costs of development as well as costs of production for biologic therapies is to develop a cell line that grows faster and produces larger amounts of vaccines and drugs using low cost synthetically defined media. Dyadic’s industrially proven C1 gene expression platform creates a stable cell line in a shortened timeline, reducing the time from gene fragment to stable cell line by 50% when compared to CHO cells. C1 stable cell lines…

Culture of 3D Cell Aggregates in Perfusion in a DASbox® Mini Bioreactor System

Three-dimensional (3D) cell aggregates are of great interest for many applications, including disease modeling, drug toxicity assessment, and manufacturing of stem cell-based products. Stirred-tank bioreactors are promising culture systems for 3D cell aggregates, as they allow efficient establishment and maintenance of cell aggregates, process monitoring and control, and process scale-up to larger volumes. Furthermore, they can be operated in perfusion mode, which allows 3D cell aggregates to be sustained longer than in traditional batch cultures. Researchers at the Instituto de…

EZ BioPac® Powder Transfer Gets Your Biologic to Market Faster, with Less Risk

This whitepaper quantifies how one simple change can drastically reduce the time it takes to get biologics manufactured. Getting media and buffer into large-scale, continuous bioprocessing has been burdensome, time consuming and messy. Upgrading to modern single-use powder handling in your process gets your product to market without time wasted on complicated weigh and dispense steps, cleaning validations, or worries about powder in the air and in the room.

Culture of 3D Cell Aggregates in Perfusion in a DASbox® Mini Bioreactor System

Three-dimensional (3D) cell aggregates are of great interest for many applications, including disease modeling, drug toxicity assessment, and manufacturing of stem cell-based products. Stirred-tank bioreactors are promising culture systems for 3D cell aggregates, as they allow efficient establishment and maintenance of cell aggregates, process monitoring and control, and process scale-up to larger volumes. Furthermore, they can be operated in perfusion mode, which allows 3D cell aggregates to be sustained longer than in traditional batch cultures. Researchers at the Instituto de…

Bioprocessing in a Time of Digital Transformation

eve® is a modular software system for bioreactors and incubator shakers, rethinking bioprocess control to meet the needs of modern users: Fast, secure access to data via a web browser from anywhere, using a range of devices The move to Big Data Analytics for process data analysis A single platform for different types of information required by different users e.g. researchers, production and quality assurance A browser-based approach to accessing this information makes considerations such as operating system, size of…

Gram Scale Transient Antibody Production and Stable Cell Line Generation Using Flow Electroporation™ Technology

In recent years researchers have turned to transient gene expression (TGE) as an alternative to CHO stable cell line production for early stage antibody development. Despite advances in transfection methods and culture optimization, the majority of CHO-based TGE systems produce insufficient antibody titers (low mg/L level) for full use within the biotherapeutic development pipelines. MaxCyte’s delivery platform for cell engineering is based on Flow Electroporation™ technology and provides a universal means of fully scalable, highly efficient CHO-based TGE for the…

Continuous Processing Optimization With Smarter Tools

Single-use technology (SUT) has long been viewed as a viable solution to today’s biopharmaceutical manufacturing challenges. It offers the flexibility to change a production configuration to meet demand while also offering many other cost benefits, such as savings related to the elimination of clean-in-place (CIP) and sterilization-in-place (SIP) processes. However, traditional and fed-batch models fail when trying to adapt to single-use flexibility due to the required rewriting of code and revalidation. The best way to use the flexibility of single-use…

Multi-Gram Scale Antibody Production Using CHO Cell Transient Gene Expression (TGE) via Flow Electroporation™ Technology

Despite advances in transfection methods and culture optimization, many CHO-based TGE systems produce insufficient antibody titers (low mg/L level) for full use within biotherapeutic development pipelines. The high productivity of MaxCyte-driven transient gene expression allows for its use in early phase candidate identification as well as for generating the gram-level antibody quantities needed for later stage pharmacology, stability and manufacturing studies. In this white paper, data are presented demonstrating the reproducibility, scalability and antibody production capabilities of MaxCyte Flow Electroporation™…

Use of the ambr®250 in Combination with High-Throughput Design and Analysis Tools for Rapid, Scalable USP Development

There have been many recent advances in high throughput (HT) technologies for upstream development, enabling processes to be developed in a fraction of the time compared with conventional methods. However, when applying this technology to biotherapeutic drug development, the suitability of the systems for developing large scale manufacturing processes and meeting regulatory demands needs to be demonstrated and ensured. Inclusive approaches encapsulating platform expression systems and fermentation technologies, parallel bioreactor systems, high throughput analytics and sophisticated design and data handling…