Special Reports

Updating the Economics of Biologics Manufacturing with 5,000-L Single-Use Bioreactors: A Paradigm Shift

Single-use technologies enable a flexibility and modularity effectively unattainable with more traditional stainless-steel technologies, particularly in upstream bioprocesses. Single-use bioreactors up to 2,000 L are employed largely in preclinical- and clinical-stage bioprocesses to leverage this flexibility. As products reach commercial maturity, scales larger than 2,000 L frequently become desirable to take advantage of economies of scale. With the typical upper limit of single-use bioreactors at 2,000 L, this has traditionally meant transfer to stainless-steel systems. The introduction of the Thermo…

Early Stage Analytical Considerations for Late Stage Biologics Success

This BPI Special Report will cover phase appropriate analytical strategies that will balance various drivers to meet overall development goals without sacrificing the requirements of a program. The goal is to provide important recommendations for analytical method development that can help the biopharmaceutical industry identify opportunities to improve lead time and reduce development costs while maintaining required quality standards. Fill out the form below to learn more about analytical method development now.   Arugadoss Devakumar, PhD, is director of analytical…

Application of Targeted Locus Amplification for Enhanced Apollo X CHO Clone Screening

Speed to market is an important consideration for the development of lifesaving therapies, including recombinant monoclonal antibodies. However, increased speed must be balanced with quality to enable quick and efficient delivery of biopharmaceuticals to patients. Important determinants of quality include the genomic location and integrity of the transgene sequence within a recombinant cell line. Traditional methods of genetic characterization can provide incomplete information and results can be difficult to interpret. However, next-generation sequencing (NGS) approaches such as Targeted Locus Amplification…

Managing Risk in Single-Use Systems Design and Implementation: A Shared Responsibility

Managing risk in single-use systems design and implementation is a shared responsibility. The ultimate responsibility for drug processes and products will always remain with manufacturers. However, implementation of single-use systems can shift responsibilities to suppliers within key areas, including design and sterilization, which must be clearly controlled and validated. This Special Report discusses how suppliers and manufacturers when working together can mitigate the risk of applying single-use systems in biopharmaceutical production from design through validation to point-of-use testing and operator…

Industrialize Your Viral Vector Production in Adherent and Suspension Cell Cultures: Know the Pros and Cons

This educational podcast, “The Evolution of Culture Systems for Viral Vector Production: Advantages, Challenges and Cost Considerations,” recently published by Cell and Gene Therapy Insights, discusses in detail the pros and cons of viral vector production in adherent and suspension cell culture. This special report illustrates how Pall Biotech’s iCELLis 500+ bioreactors and Allegro STR bioreactors can bolster adherent and suspension culture, respectively, for viral vector production. Fill out the form below to read the complete report and learn more now.…

Are You Missing the Bigger Picture with Your AAV Analytics? Fast, Low-Volume Subvisible Particle Analysis for Characterizing Viral Vectors

Subvisible particle (SVP) analysis is a key indicator of stability and safety and is an essential parenteral drug quality metric. Yet assessment of SVPs is especially challenging in adenoassociated virus (AAV) vector formulations, in which limited precious sample is available. Traditional SVP methods consume large sample volumes, while dynamic light scattering (DLS), size-exclusion chromatography (SEC), and visual inspection can miss aggregates in the subvisible range entirely. This special report introduces backgrounded membrane imaging (BMI) technology as a solution for detection…

Bioprocessing 4.0 Accelerates Biological Research and Development Using Computer-Aided Biology

Computer-aided biology describes a growing ecosystem of tools that augment human capabilities in the laboratory. In this report we give two case study examples of how computer-aided biology has transformed industrial gene therapy bioprocessing. Read on to discover how Synthace’s Antha cloud-based software platform has enabled industrial collaborators Oxford Biomedica and the Cell and Gene Therapy Catapult to harness the power of Bioprocessing 4.0 by: incorporating new process analytical technologies (PAT), such as Raman Spectroscopy, into their unit operations automating…

A Future-Proof Solution for Bioprocess Applications: The New Eppendorf Flexible Bioreactor Control System Evolves with the Changing Needs of Modern Biotechnology

In the biopharmaceutical industry’s quality-by-design (QbD) era, optimizing tools for process monitoring and control has become a major focus of development and manufacturing. This increased attention brings challenges into upstream and production processes, cell-line development, process optimization, and scale-up. Suppliers of equipment and technologies also focus on helping their customers improve development timelines. With that increased attention to speed, they are offering tools such as the Eppendorf SciVario twin bioreactor control system to streamline development and maximize flexibility. BPI spoke…

Upstream: Make the Right Decisions for Your mAb

Bioprocess decisions made during upstream operations can be difficult to reverse at later, more costly stages of biologic manufacture. They even can require significant backtracking, wasting precious time, labor, and material. Read this Special Report to learn ways to optimize monoclonal antibody bioprocessing upstream. Specifically, you will learn about different tools that small and emerging biotechnology groups can use to ensure robust cell-line selection novel media formulations designed for intensified upstream processing in perfusion modes mixing and delivery solutions that…

Trends in Data Analytics As Organizations Undergo a Digital Transformation

The biopharmaceutical industry is in the midst of an exciting transformation as biologics experience massive growth — even outpacing the small-molecule segment (1). Biologics are predicted to comprise over a quarter of the pharmaceutical market in 2020 (2). At the same time, a plethora of new biologically derived therapy concepts — e.g., cell and gene therapies — are in development. Some biologics classes have become mainstream — e.g., monoclonal antibodies — with biosimilars entering the market and contract manufacturing organizations…