Manufacturing

Big Solutions Come in Small Packages: Expanding Sterile Connection Technology to Small-Format Product or Process Fluid Volume Transfer Applications

This webcast features: Troy Ostreng, Senior Product Manager, Colder Products Company In state-of-the-art biopharmaceutical manufacturing, you’re challenged to engineer and operate processes that are robust, reliable and repeatable. Building on the inventiveness of CPC and its AseptiQuik® Series Connectors, the leader in single-use connection technology, the company’s new MicroCNX™ Series Connectors provide a modern alternative to the tube welding process. In this presentation, CPC’s biopharma senior product manager, Troy Ostreng highlights how this new category of aseptic, sterile micro-connectors provides…

Top Considerations for the Development of Inhaled Biologics

This webcast features: Ashleigh Wake, Business Development Director, Intertek Pharmaceutical Services Inhaled and nasal biologics continue to grow in importance as advantages presented both by targeted delivery to the lung and systemic delivery for other diseases or treatment pathways are driving this increased attention. In this webinar, Ashleigh Wake describes the top development considerations for inhaled or intranasal biologic analytical development. These include the need to meet regulatory requirements of ICH Q6B for a well characterized biologic as well as…

BioProcess Insider State of the Industry — September 2021 Panel Discussion

Our BioProcess Insider editorial team sits down with Joshua Speidel, PhD Partner, Latham Biopharm Group, Patrick Lucy, President and CEO, Lykan Biosciences, and Amélie Boulais, Head of Market Entry Strategy, Virus Based Therapeutics at Sartorius, to reflect on how the quarterly movements of the wider pharma industry are affecting the biomanufacturing space. Through the analysis of global events, recent deal making, and regulatory and technological advancements, we look to determine the factors driving or squeezing production and pre-empt upcoming trends…

Improve Productivity and Operational Efficiency with Single-Use Technology

This webcast features: Rob Martindale, Product Manager, EMEA, Masterflex In many manufacturing environments, and especially in the biopharmaceutical market, there is a constant emphasis on making productivity improvements and streamlining every-day processes. One solution that many companies are turning to is the implementation of single-use technology. In this webinar, we will expand on what’s possible with single-use technology and then highlight practical ways single-use technology can make positive impacts on your workflow and on your bottom line. Just fill out…

rEVolutionizing Acellular Therapies with Corning HYPER Technology

This webcast features: Amy C. Kauffman, PhD, Senior Development Engineer, Corning Life Sciences Extracellular vesicles (EVs) are a population of particles that are naturally released from cells. They are involved in intercellular communication, providing the necessary factors to mediate physiological events, and they are of high interest because of their potential for becoming the next generation of therapeutics. One potential area of interest is in generating an EV therapeutic in place of mesenchymal stem cell (MSC) therapies for pathological conditions…

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…

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…

HCP Analysis by ELISA and Orthogonal Methods in Vaccine and Gene Therapy Development

This webcast features: Jared Isaac, PhD, Sr. Scientist, Chromatography and Mass Spectrometry, Cygnus Technologies Next-generation recombinant vaccines and gene therapy products require clinical and commercial manufacturing of protein antigens or viral vectors produced using cell culture technologies. Regulatory guidelines require testing for cell substrate related impurities, media and purification additives, as well as adventitious agents throughout vaccine and gene therapy development to study the candidate’s purity, safety, and efficacy. While low levels of most impurities can be inconsequential, patient safety…

How to Optimize Final Filling in Bioprocessing

This webcast features: Andeka Ocio Velasco, Manufacturing & Process Validation Technician, Progenika Biopharma, a Grifols company; and Robert Martindale, Product Sales Manager, Masterflex EMEA, Antylia Scientific The final filling mistakes within bioprocessing are far too expensive to be allowed or tolerated. Continuous optimization is a commitment that all companies need to embrace to increase business profitability potential. Evaluating and utilizing new technologies will enable a faster methodology of process, increase the scaling up of bioprocesses, and increase the accuracy of…

Tools for Simplifying MSC Expansion, Cryopreservation, and DMSO Removal

This webcast features: Hilary Sherman, Senior Scientist, Corning Life Sciences Mesenchymal stem cells (MSCs) are one of the most frequently utilized cell types for cell therapy applications due to their ability to be isolated from several sources and easy adaptability to culture conditions. Bone marrow derived MSCs in particular are commonly studied due to their ease of access and achievable therapeutic dosage. While expanding MSCs to achieve these quantities, there is a risk for heterogeneity-induced quality failures during the manufacturing…