Author Archives: BPI Contributor

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…

Dynamic Dialysis: A Novel Process-Scale Membrane Separation for GMP Manufacturing

This webcast features: Daniel (Danny) Spurgin, Product Manager, and Cassidy Markee, Bioprocess Sales Specialist, Repligen While static dialysis is used routinely in research and sample analysis, dynamic dialysis is increasingly used today for the purification of macromolecules, proteins, nanoparticles, biomolecules, polymers (polypeptides, polysacharide, oligos), virus for vaccine and delicate/shear sensitive species. It is also ideal for the purification of viscous fluids and hydrogels (hyaluronic acid – HA) that cannot be filtered. Where traditional filtration methods may fail, dynamic dialysis uses…

Single-Use Sensors and Control and Data Acquisition Tools to Streamline Bioprocess Development

Process development and biomanufacturing in the biopharmaceutical industry have evolved extensively over the past 10 years. More tools are available to study process variables to enable more efficient and productive processes, speed development, and reduce costs. High powered microcontrollers are embedded in laboratory devices to carry out complex tasks. Recently, users have started working with microcontrollers such as Raspberry Pi for personal projects. As personal computer power has accelerated multiplefold,leading to high processing power and compact, high-capacity memory readily available…

Minimizing Resources in Developing Commercial Virus Filtration Processes with Planova BioEX

This webcast features: Roya Dayani, Senior Product Manager, Asahi Kasei Bioprocess Europe Establishing a virus filtration step in biopharmaceutical development and manufacturing process may require a large amount of resources (i.e., time, manpower and cost). These can be minimized with swift process development, smooth scale-up and worry-free operations. In this webinar Asahi Kasei Bioprocess will answer the question “What are the main requirements for a virus filter at each phase?”. You will learn through different case studies the filtration performances…

New High Performance AEX Resin for Large Biomolecule Purification

This webcast features: Jiali Liao, Principal Scientist, Process Chromatography R&D, Bio-Rad Laboratories Large molecule purification can be difficult due to their size. This leads to slow diffusion and mass transfer kinetics of the molecules into the pores of traditional chromatography resins, which decreases their binding capacity and resolution. In this webinar, Dr. Jiali Liao will introduce the design features of the Nuvia HP-Q bead matrix that help overcome these purification challenges. Case studies on plasma protein and virus purification will…

Key Considerations for Advanced Therapies Manufacturing

This webcast features: Thomas Page, PhD, Vice President, Engineering and Asset Development, Fujifilm Diosynth Biotechnologies This technical webinar covers key considerations to support manufacturing activities from the earliest stages of cell line, viral replication platforms and/or viral vectors identification stage leading into clinical production. Having a line of sight into commercial production and the requirements leading into commercial approval are also essential for success. Key messages: Flexibility in conjunction with high containment are key for success Application of closed systems…

Accelerated Development, Manufacturing and Monitoring of Viral Vectors

The goals of process intensification are to enhance production while shortening timelines, lessening contamination and environmental risks to products and operators, and reducing operating footprints. Previous publications from Sartorius Stedim Biotech (SSB) have highlighted key elements of such activities. In this report, the authors extend the scope of this discussion to tools and technologies that enable intensification of viral vector manufacturing processes. The first article summarizes presentations from a 2018 seminar for viral vaccine manufacturers. Three guest presentations highlighted the…

Accelerating Biopharmaceutical Development with High-Throughput Glycan Screening and Multiple Attribute Methodology

Part 1 Development of biopharmaceuticals comprises many integrated steps, beginning with research and discovery and optimally ending with a commercial therapeutic molecule. Early screening of large numbers of clones and cell culture expression conditions is essential to identifying proteins that carry to greatest likelihood of clinical and commercial success. Part one of this report reviews how high-throughput glycan screening can significantly improve current analytical strategies relating to cell line development. Part 2 Minor impurities and changes in attributes such as…

Optimizing Unit Operations In Biopharmaceutical Manufacturing

There are many critical material-handling challenges regarding flow rates, pressure levels and the prevention of shear in the chromatography, virus filtration and TFF processes that are used in the manufacture of biopharmaceuticals. In order for these unique operations to be implemented successfully while handling fluids that can be sensitive, delicate and expensive, the operator must be aware of their specific operating characteristics and choose a pumping technology that can meet the strict demands for successful operation. While lobe and peristaltic…

Pfizer CentreOne Contract Manufacturing

Pfizer CentreOne is a global contract development and manufacturing organization (CDMO) embedded within Pfizer. We focus on custom API synthesis, sterile injectable fill–finish, and highly potent oral solid dose; and we are a leading supplier of steroid and hormone APIs and intermediates. For more than 40 years, we’ve manufactured complex compounds for our biopharmaceutical partners, guiding their drugs safely from development through commercialization. The Value of the Embedded-CDMO Model: Your molecule is manufactured in the same facilities that produce Pfizer’s…