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Enabling Pharma and Biotech Innovation Through an Open-Access Platform: Targeted Protein Degradation

Presented by: Dave Madge, vice president, research division, WuXi AppTec Madge described methods that his company applies to identify and evaluate bifunctional molecules that mediate targeted protein degradation (TPD). He pointed out that although much TPD research focuses on proteolysis targeting chimera (PROTAC) compounds, the tools used to identify such molecules also can be used to evaluate the therapeutic potential of other bifunctional molecules. Of particular interest are those that bring “housekeeping proteins” to disease-causing targets. More broadly, researchers are…

BioProcess Insider Interview: Sam Machour, Samsung Biologics

BioProcess Insider brings the biotechnology news as it breaks. For the on-demand BPI Theater at the Biotechnology Innovation Organization’s 2021 convention, founding editor Dan Stanton interviewed leading biopharmaceutical executives in early June 2021. Contract development and manufacturing organizations (CDMOs) have thrived during the COVID-19 pandemic despite constraints on supply chains. Sam Machour, senior vice president and chief quality officer at Samsung Biologics explained that his company’s pandemic-period success has stemmed primarily from its ability to accelerate production timelines. Before 2020,…

Media Management: A Critical Consideration Before Intensification

Process intensification (PI) enables faster drug development and increased productivity, flexibility, and quality. But PI can also introduce the challenge of increased media volumes and how to manage them in upstream processes. This whitepaper provides the tools and information needed to consider PI options while evaluating the implications of media management. Follow the media journey from prep to use, exploring potential logistical pitfalls in managing increased media volumes associated with process intensification. Finally, see how the right equipment and platforms…

BioProcess Insider Interview – Marc Hummersone, Astrea Bioseparations

BioProcess Insider brings the biotechnology news as it breaks. For the on-demand BPI Theater at the Biotechnology Innovation Organization’s 2021 convention, founding editor Dan Stanton interviewed leading biopharmaceutical executives in early June 2021. Highlighting the rapid proliferation of cell and gene therapies (CGTs), Hummerson described how his company seeks to support downstream processing for emerging therapies. Hummerson reflected that when he joined the biopharmaceutical industry in 2006, developers of monoclonal antibodies (MAbs) expressed great need for innovative purification solutions. The…

CGMP Manufacturing Facility Design and Evolution

Presented by: Mike Alston, Jr., director, project engineering; and William Leonardi, PhD, senior project manager, Avid Bioservices These two speakers shared lessons learned in the design and buildout of current good manufacturing practice (CGMP) manufacturing facilities at Avid. Leonardi began with a history of the company’s 28+ years of biologics development and manufacturing and its track record as a successful contract and development manufacturing organization (CDMO). Avid’s main campus comprises a cluster of buildings in Tustin, CA. GMP, process-development, and…

Scalable Lentiviral Vector Manufacturing Using Proprietary Suspension Cell Line

This webcast features: Xiao Pan, Director of Process R&D, GenScript ProBio Fueled by recent successes of marked cell therapy products, the demand for high-quality and large-amount lentiviral vectors is also becoming greater. However, producing lentiviral vectors in an adherent system has many limitations, mainly around scalability and serum dependence. To overcome these difficulties, there is an urgent need for stable and scalable lentiviral vector manufacturing using a suspension system. GenScript ProBio is dedicated to developing lentiviral vector platforms using our proprietary…

Octet® Bio-Layer Interferometry Systems: Advancing Development of Coronavirus Vaccine and Therapeutics

Development of vaccines and therapeutics to target outbreaks of infectious diseases such as SARS-CoV-2 requires speed and agility. An essential part of this rapid response are technologies designed to streamline and accelerate workflows while delivering high quality data for informed decision-making. This compendium of applications demonstrates the use of the Octet® label-free platform utilizing bio-layer interferometry (BLI) technology to advance development of coronavirus vaccine and therapeutics. The fluidic-free approach offers important advantages over microfluidics-based technologies such as surface plasmon resonance…

Strategies for Successful Formulation Development of Lipid-Based RNA Delivery and Vaccines

Nucleic acid therapy using RNA and DNA as the active pharmaceutical ingredient (API) has the potential to cause a paradigm shift in the way diseases are addressed. This innovative therapy targets the source of the disease at the genetic level and can be used to modulate the expression of one or more proteins simultaneously – a unique advantage over conventional biologics or small molecules. Given this mode of action, RNA and DNA therapeutics are a powerful means to treat, and…

Shaping the Future of Formulation Development with Melt-based 3D Printing Technologies

Three-dimensional (3D) printing is a powerful technology that has wide-ranging applications, including many in the pharmaceutical industry. Among the approaches that are being explored in the production of pharmaceutical dosage forms powder-based systems which utilize either drop-on-powder or selective laser sintering and liquid-based systems which use drop-on-drop deposition or stereolithography are frequently applied. With liquid-based technology, either UV, laser energy or high temperature is used to induce polymerization and build the 3D structure. The process of 3D printing offers the…

Can CDMOs Provide Leadership in Cell and Gene Therapy?

Cell and gene therapies are poised to usher in a new era of healthcare. As of June 2021, 14 cell and gene therapies have been approved for clinical application in the United States, and over 400 more are in various stages of clinical trials. The hopes of many patients hinge on the success of these various programs, which are designed to deliver a significant advance on existing treatments or even a functional cure. As new cell and gene therapies get…