Author Archives: BPI Contributor

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…

Establishing Commercial Manufacturing Services for Antibody-Drug Conjugates

The pipeline for antibody–drug conjugates (ADCs) includes hundreds of candidates, with several expected to receive approval in the near future. As more commercial products reach the market, there is an acute need for CDMOs that understand how to execute late-stage studies to support a filing strategy. CDMOs with plans to support commercial-scale ADC manufacturing are setting up processes to handle challenging supply chains and investing in facilities and processes to ensure efficiency, quality and security. In this white paper, we…

Process Intensification: Ways to Achieve Extreme Biologics Volumetric Productivity

This webcast features: Xiao Pan, Director of Process R&D, GenScript ProBio The trend of biologics titer increase brings significant cost reduction. Process intensification needs to be introduced and applied to improve the titer performance and lower the COGS. Besides fed batch, GenScript ProBio has developed process intensification solutions including high-density inoculation and intensified perfusion. Through this webinar, you will learn the following information: The scope and trend of process intensification Intensified perfusion development roadmap Case study of process intensification Just…

The Path Toward Successful Innovation in Gene Therapies

This webcast features: Roland W. Herzog, PhD, Professor of Pediatrics, Riley Children’s Foundation Professor of Immunology, and Director of the Gene and Cell Therapy Program, Indiana University School of Medicine, and Nagendra Venkata Chemuturi, PhD, Scientific Director Research, Global DMPK, Takeda Pharmaceutical Company Gene therapies based on adenoassociated virus (AAV) vectors are emerging as a promising treatment strategy for various diseases, including an inherited form of blindness and spinal muscular atrophy. A major obstacle for the wide use of gene…

The Importance of Real-Time CO2 Monitoring in Cell Culture

This webcast features: Oliver Berteau, Pharmaceutical & Biotech Industry Manager, METTLER TOLEDO Process Analytics Inline dissolved CO2 (dCO2) measurement and monitoring during cell culture offers significant benefits for process control impacting productivity and quality attributes. Real-time dCO2 measurement complements routine dissolved CO2 measurements with a blood gas analyzer (BGA) during preclinical and commercial operations. Animal and insect cells are more or less sensitive to the level of dCO2 during cell culture. Toxic below and beyond specific thresholds, dCO2 is also…

The Critical Steps for Protein Therapeutic Potency Assay Development

This webcast features: Jennifer Lawson, PhD, Global Product Manager, Cell Banking and Testing, Sartorius Potency assays are an important part of the drug development process and are required throughout the lifetime of the product. The potency assay needs to correlate with the mechanism of action and provide an indication of stability. With these requirements comes a myriad of challenges in the development process, especially as therapeutics become increasingly complex. Assay development should be stepwise, starting with proof of concept and…