Manufacturing

Rapid Mammalian Cell Harvest Without Centrifugation for Antibody Purification: Using a Novel System for Cell Culture Media Clarification

Monoclonal antibody (MAb) expression systems typically use signal peptides to ensure secretion of antibodies into cell culture media. Although that reduces the complexity of purification and prevents the need for cell disruption, it does require using expensive and time-consuming techniques to separate cells from antibody-containing cell culture fluids. In this study, we describe our tests of the novel Sartoclear Dynamics Lab V system (Sartorius S Lab Instruments GmbH and Co. KG) for rapid clarification of cell culture media without requiring…

Smart Sensors and Data Management Solutions for Modern Facilities

Bioprocess manufacturers continue to seek technologies for increasing productivity and shortening timelines from discovery to commercialization. Innovations such as high-throughput systems, automated platforms, and the latest clarification systems all have made processes efficient and robust. And with the increasing adoption of quality by design (QbD) principles, including the use of process analytical technologies (PAT), biomanufacturers are mitigating the risks of errors in their operations better than ever before. A critical part of mitigating risk is gathering meaningful process data and…

Rapid Implementation of Novel Affinity Purification: Manufacture of Commercial-Scale Next-Generation Antibody Therapies

The rapid and cost-effective production of conventional monoclonal antibodies (MAbs) for clinical trials and commercial supply has contributed toward their wide adoption. Production processes have become more efficient because common purification processes are being used across structurally similar MAbs during key steps of process development and manufacturing. Such successful platform approaches can remove unwanted impurities and are stable across processing conditions, irrespective of the MAb being purified. In addition, they are readily available at the required volume to support large-scale…

CMC Development Platforms and Outsourcing to Reduce Timelines

Forty Seven is a company developing novel therapies based on anti-CD47 and other immuno-oncologies. CD47 is called the “don’t eat me” signal that cancer cells give out to escape elimination by the body’s immune system. Qinghai Zhao, vice president of technical development and manufacturing, is one of the scientists working on the company’s magrolimab (5F9) monoclonal antibody that is designed to block the binding of the CD47 signal to the cell receptor SIRP-α while boosting the “eat me” signal that…

eBook: Autologous Cell Therapies: Commercialization Strategies

Autologous cell therapies are derived from a patient’s own stem cells, typically collected from bone marrow. Those cells are then cultured, expanded, and reinfused back into the patient. Unlike allogeneic cell therapies, this process is repeated for each dose and for one patient. The one-to-one process carries several challenges to commercialization, including high development costs, the need to control the risks of manual processing, and compliance with strict timelines. This eBook presents two perspectives on addressing these challenges. The first…

Emerging Treatments for Spinal Cord Damage

Injuries to the spinal cord can cause permanent paralysis and even lead to death, with little or no hope for patients to regain lost function after such trauma has occurred. News of my spinal cord research first came to prominence in the 1980s with a front-page story that chronicles a presentation at the annual Society for Neuroscience meeting (1). That reported the first time that crushed peripheral nerves had been regenerated back into a patient’s spinal cord. Regeneration of spinal…

Biopharmaceutical Growth in China: Bioprocessing Challenges Are Creating CMO Opportunities

In the past decade, the world has seen rapid growth of more than 15% in China’s biopharmaceutical market (1). According to the second edition of BioPlan’s Advances in Biopharmaceutical Technology in China, the most populous country in the world — with the largest patient groups — has a growing economy with its GDP second only to that of the United States. Rapid urbanization and greater access to national healthcare insurance puts China in second place after the United States for…

Control of Protein A Column Loading During Continuous Antibody Production: A Technology Overview of Real-Time Titer Measurement Methods

During production of therapeutic antibodies, harvest titer is measured to monitor product mass loaded onto the protein A capture column. This prevents both column underloading (underusing expensive resin) and overloading (wasting product as flow-through (FT)) while allowing for column yield calculations. Batch production yields a single homogenous harvest pool, thus only one titer measurement (along with volume loaded) is sufficient to determine the mass loaded. During continuous production, however, cell-free harvest (permeate) continuously exits a perfusion reactor and loads a…

Advances and Challenges in Vaccine Development and Manufacture

Scientists have made significant breakthroughs in bioprocess and analytical technologies for supporting vaccine development. Such technologies have helped vaccine manufacturers achieve consistent product purity and quality rapidly and cost effectively. Although interest in vaccine development and manufacture continues to increase because of the rapid growth of the global vaccine market, this area of the bioprocess industry remains challenging and complex. Here we review the current constraints and complexities in the vaccine industry, specifically related to product development and manufacture. We…

Formulation Development of Microbiome Therapeutics Localized in the Intestines

Scientists have discovered that microorganisms associated with the body play a critical role in human health (1). The intestinal microbiome is the collection of all combined genetic material of microorganisms in the intestines. An intestinal microbiota, a term frequently used interchangeably with microbiome, is the collection of such microorganisms in the intestine. With the volume of research into the human microbiome expanding, so too is the number of examples of its benefits to our health (1). Like diseases of the…