Sponsored Content

Supporting Small and Virtual Companies for Clinical Trials

SPONSORED   The virtual pharma business model has gradually become a popular alternative to traditional pharma. As an integrated service provider, Yourway offers the logistical support from study design to packaging needed by virtual and small companies entering into clinical trials. Yourway is a large organization that has flexible solutions embedded in our offering, and this nimbleness and agility help us to provide optimal solutions to virtual pharma companies. Virtual pharma companies are not bound to an organization’s internal, in-house service…

Mixed-Mode Chromatography Resins​ for Biomolecule Purification

This webcast features: Dr. Xuemei He, R&D Chromatography Media Chemistry Manager, Bio-Rad Laboratories Mixed-mode chromatography has emerged as a viable purification method for biomolecules that are otherwise difficult to purify using traditional chromatography platforms and other established means. Scientists are gaining an increased understanding of mixed-mode mechanisms and how these interactions impact selectivity. The industry is becoming more adept at including mixed-mode steps in production processes while also working to address robustness, platform fit, and productivity. This webinar will examine…

Effectively Securing Cell and Gene Therapies with Closed Systems

With their innovative new treatments, cell and gene therapies (CGT) are growing rapidly. But their traditional production processes don’t allow the supply of these therapies to keep up with demand. Historically, these therapies are produced for small patient populations in clinical trials using laboratory scale equipment and utilizing manual, open processes completed under laminar hoods. But manufacturers looking for more efficiency and flexibility are turning to new solutions. One key area of interest is the implementation of a closed system…

Characterization Platform for Structural and Functional Feature Investigation of Bispecific Molecules

Bispecific antibodies (BsAbs ) bind to two or more targets which could be different antigens or different epitopes. Structurally, one type of bispecific antibody is similar to an IgG which contains an Fc region, and other bispecifics do not have an Fc region and typically have a relatively small molecular weight. Therefore, the characterization for a bispecific is more challenging than for a typical monoclonal antibody because of this variation in structure. The poster here discusses a set of platform…

Robust Stable Line Platform for Biologics Development

This webcast features: Dr. Sean Liour, Vice President for Project Management, GenScript ProBio A cell line platform can provide the best solution for the biopharmaceutical target. This webinar explains how to develop a robust stable line platform for CMC projects. GenScript’s biologics platform can provide one-stop service of CMC for the biopharmaceutical target. Just fill out the form below to watch the recorded webcast now.

Understanding and Controlling Raw Materials Variation in Cell Culture Media

The FDA requires biopharmaceutical manufacturers to understand and control sources of variation according to the risks they present to process and product. Cell culture media and feeds have been shown to affect cellular performance, product quality, or both. The evolution of media formulas to those that are serum-free and chemically defined poses both a challenge and an opportunity. The challenge is identifying which of the many components have the greatest impact on cells and the molecules they produce. The opportunity…

Cryogenic Temperatures and Cell Viability

This webcast features: Dr. Peter Kilbride and Dr. Julie Meneghel, Senior Research Scientist and Cryobiologist, GE Healthcare Life Science In this webinar, we will address fundamentals of cryobiology to (1) understand why a cryopreservation protocol is needed, (2) see what happens biologically to cells while cooling, and (3) allow attendees to design an optimized protocol for their cell type and cryopreservation configuration (e.g., sample size). We will cover the importance of applying controlled-rate cooling and how to best tune it to…

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…

Implementation of Single-Use Miniature Bioreactors to Support Intensified Cell Culture: Using Functional Performance Indicators to Assess a Small‑Scale Model

Changes to bioprocessing in the biopharmaceutical industry are driven by the need for increased speed, lower cost of goods (CoG), and greater flexibility (1). To meet these challenges, the industry is adopting strategies that include intensified processing. During the initial stages of intensified processing, it is essential to identify the most productive and/or stable clones for use before starting pilot-scale studies. That requires screening large numbers of clones and then further testing the most promising ones in benchtop bioreactors. The…

Ask the Expert: Accelerating Development and Manufacturing Platforms for Viral Vectors

Bai-wei Gu, Juan Lagos, and Matthew Weaver (heads of cell line development, upstream process development, and downstream process development groups, respectively, at WuXi Advanced Therapies, ATU) joined forces on 29 October 2019 to feature their company’s viral-vector manufacturing capabilities for cell and gene therapies. In addition to adherent platforms for lentivirus (LV) and adenoassociated virus (AAV) vectors, ATU soon will offer suspension-cultured viral vector platforms for them as well as analytical measures that support release testing. Transitioning from adherent to…