INSIGHTS ON CELL & GENE MANUFACTURING

  • End-To-End Process For Oncolytic Adenovirus Production
    End-To-End Process For Oncolytic Adenovirus Production

    Oncolytic viruses constitute a new promising therapeutic approach for treatment of cancer. Here’s an example of a scalable, end-to-end process for oncolytic adenovirus production using modern tools and technologies.

  • Adenovirus Production In Single-Use ReadyToProcess WAVE™ 25 Bioreactor System
    Adenovirus Production In Single-Use ReadyToProcess WAVE™ 25 Bioreactor System

    Using rocking bioreactor systems can shorten the seed train prior to inoculation and provide optimized growth conditions for sensitive cells. This study presents a robust production of adenovirus using a rocking bioreactor system.

  • Digital Manufacturing Of Biologics
    Digital Manufacturing Of Biologics

    In addition to an explanation of digital manufacturing, this paper covers how it can improve the productivity and robustness of existing processes and facilities. Gain and understanding of digital biomanufacturing for upstream and downstream processes as well as the technologies that support digital manufacturing of biologics.

  • The New Age Of Digital Biomanufacturing
    The New Age Of Digital Biomanufacturing

    Advances in bioprocess monitoring and analytics, as well as in bioinformatics and computational biology, are changing the way we look at the bioproduction process. This poster explains the drivers of the digital biomanufacturing revolution and how they are steering us towards science-based increased plantwide efficiency, quality, adaptability, and profitability.

  • Addressing Unique Production Problems In Cell and Gene Therapy With Manufacturing Execution System (MES)
    Addressing Unique Production Problems In Cell and Gene Therapy With Manufacturing Execution System (MES)

    Do you work in the supply chain, manufacturing operations, quality control or IT departments of cell and gene therapy companies and are close to obtaining therapy approval or scaling up to commercial manufacturing? Read how to select an manufacturing execution system (MES) to address the unique production problems of cell and gene therapy.

  • Optimizing Process Efficiency In Upstream Manufacturing
    Optimizing Process Efficiency In Upstream Manufacturing

    Increasing the integration of upstream and downstream processing and moving toward increased automation results in greater optimization of process efficiency - a key goal for biopharmaceutical production.

  • Take Cell And Gene Therapy Supply Challenges By The Horn
    Take Cell And Gene Therapy Supply Challenges By The Horn

    While traditional biotechnology focuses on material inventory, cell therapy products must account for the entirety of a patient’s journey in order to develop a robust supply strategy. 

  • Overcoming The Unique Filling Challenges Of Autologous Therapies
    Overcoming The Unique Filling Challenges Of Autologous Therapies

    Autologous (patient-derived) therapies represent unique challenges to processing. One-patient, single-batch is a radical change from the scale our industry is accustomed to. At this level the filling is more analogous to limited Phase 1 clinical trial materials or even preclinical applications. The logistics and required compliance of manufacturing these personalized therapies is drastically different and presents a combinatorial explosive problem. One aspect of this process where traditional methods fall apart is filling of these therapies.

  • Dos & Don’ts Of Bioprocess Facility Construction
    Dos & Don’ts Of Bioprocess Facility Construction

    Expansions and renovations to existing biological facilities, and construction of new facilities, provide a unique opportunity to rethink basic design strategies and use new technologies to build a better facility that will improve compliance. This article is the sixth in a six-part series on how single-use systems (SUS) are changing the modern biotechnology facility design and construction paradigm.

  • Cell Therapy: Process Design Considerations To Support Commercialization
    Cell Therapy: Process Design Considerations To Support Commercialization

    Cell therapies have the potential to revolutionize the biopharmaceutical world, but today’s processes, logistics, and delivery make for a challenging entry into the sector’s growth curve. As the industry evolves, we have to answer (at least) three important questions when bringing these exciting new therapies to market.

More Insights On Manufacturing