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

1. Getting Your Investigational Drug Regulatory Ready 12/1/2020

   Here, we map out basic information to help you approach regulatory policies and offer helpful strategies to facilitate efficient regulatory review and drug approval.

2. Real World Experience: Modular Facilities, Smaller Footprint With Dynamic Perfusion 5/11/2021

   Established manufacturers are looking to single-use, flexible solutions when building new facilities or modifying existing operations. Their goal is to increase productivity across different modalities, including difficult-to-express molecules. Read this success story to understand how dynamic perfusion enabled a CDMO to increase throughput dramatically while establishing a multi-modality facility.

3. Using In-Line Sensors For Real-Time Control 9/28/2020

   There's a biopharma production shift from manual processes to automated intervention. This paper exemplifies the use of sensors for in-process control of upstream and downstream process parameters.

4. Closed Manufacturing System For Autologous Cell Therapy Production 4/16/2021

   Complete manufacturing system delivered technology innovation, novel automation solutions, and substantial IP in the cell therapy manufacturing automation domain.

5. Custom Designed Clinical Manufacturing Cleanrooms For Penn Medicine’s Cell And Gene Therapy Operations 8/9/2019

   A GMP manufacturing suite was developed which included a custom-designed and constructed Clinical Manufacturing cleanroom core for producing PENN Medicine's cell and gene therapy candidates.

6. Mechanistic Modeling Of Chromatography To Speed Up Process Development 3/2/2020

   Catch up on the current opportunities and challenges for using mechanistic modeling to simulate and predict chromatographic behavior and experiments in silico. 

7. Expansion Of T Cells Without Serum In Chemically Defined Media 5/27/2021

   Major components used to expand these T Cells include human and bovine serum, as well as proteins derived from these substances. These components not only have the  potential to introduce harmful pathogens to the already compromised patient in a clinical setting, but they also have significant limitations in the ability to ensure robust and reproducible performance in cell culture systems. This application note demonstrates how OptiPeak T Lymphocyte blood-free medium’s potential as a viable and regulatory-friendly option for T cell immunotherapy manufacturing.

8. Security Of Supply In Cell And Gene Therapy Manufacturing 9/24/2020

   With so many challenges in cell and gene therapy manufacturing, building an adequate supply chain with the necessary equipment and protocols is critical for companies pursuing these life-saving drugs.

9. How To Develop A Cell Therapy Manufacturing Roadmap 5/26/2021

   A good manufacturing roadmap provides flexible guidelines to advance automation. It’s a living document and will be refined many times as manufacturing needs and processes evolve. The key is mapping out the entire process and developing a clear understanding of what needs to be done and when. Here are the key questions to ask when building a manufacturing roadmap.

10. Animal Component Free (ACF) Media Development For Cell Therapies 11/26/2019

    In the extremely fast-paced era of cell and gene therapies, the use of chemically defined (CD) ACF cell culture media is strongly encouraged by the regulators. However, the commercially available options are very limited or prohibitively expensive when available. At CCRM, we have developed a high-throughput, fully automated pipeline that allows us to formulate ACF and CD cell culture media fully tailored to the cell or gene therapy of interest.