Cell And Gene Articles, App Notes, Case Studies, & White Papers

  1. Process Development In Gene Therapy: 4 Things To Know 5/12/2021

    Considering everything it takes to scale up gene therapy — the platforms, the media, the surfaces, the vessels, the equipment — developing viral vector production processes comes with many challenges. It's no surprise, then, that labs sometimes miss a few things when scaling their gene therapeutics up or out, and those oversights can set projects back. In this article an industry expert identifies four essential things to know about scaling gene therapy processes.

  2. Single-Use Technology For The Most Extreme Processes 6/7/2021

    Downstream processing for biologic drugs often requires the use of harsh chemicals that can damage SUT components. CPC designers identified a polymer that helped reproduce an AseptiQuik connectors to handle rough downstream chemicals.

  3. Process Characterization: Ready For The FDA? 3/6/2020

    Realizing the benefits of process characterization requires proper planning and application of a comprehensive process characterization strategy.

  4. Integrating Ancillary Systems – A Bridge To Closed Cell Therapy Manufacturing Processes 5/18/2021

    The next phase of growth in the CGT industry is expanding automation into ancillary processes. Although lessons can be learned from the current biopharmaceutical sector, the material and packaging requirements for CGT are unique. As a response to this need, platforms have been established to support the specific needs of this industry. 

  5. Emerging Industry Trends And CMO Solutions For Protein Fermentation 9/3/2020

    Many biotechnology, food and advanced material developers are now seeking to develop and commercialize their protein-based products utilizing microbial fermentation processes.

  6. Advantages Of Automated Filling Of Bulk Biopharma Drug Substances 5/26/2020

    A biopharma compared costs, advantages, and disadvantages of manual handling versus automated filling of bulk drug substance, prompting a switch to next-level automated drug substance handling.

  7. 8 Ways Osmolality Tests Improve Cell & Gene Process Dev, Manufacturing 12/17/2020

    Cell and gene therapies have the potential to revolutionize incurable, debilitating, and often fatal diseases. This paper outlines eight emerging and novel uses for osmolality testing in advanced therapy production.

  8. Biosimilars Developer Automates Delivery Of External Manufacturing Partner Batch Data To Accelerate Workflows 5/31/2021

    A leading pharmaceutical company relies on CMOs to produce clinical and commercial biosimilars and other pharmaceuticals at scale. In support of its manufacturing operations, the company’s external partners collect large volumes of batch data that must be approved and reconciled; however, it had relied on manual processes, differently formatted spreadsheets and PowerPoints, email, and network file folders to manage batch records. The company needed a solution that could improve data visibility and sharing across their globally dispersed CMO network, automate process data analytics, and easily centralize and manage batch data, process specifications, and control limits.

  9. Identifying The Best People To Run A Clinical Study (And How To Hire Them) 6/15/2021

    No matter how brilliant a clinical trial process or a technology may be, it is useless without skilled, motivated individuals at the helm.  

  10. Developing A Continuous Large-Scale Perfusion Cell Culture Process 9/25/2020

    The key benefits of perfusion processes are compact process design, flexibility, increased productivity, increased yield, and consistent product quality.