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

1. Delivery And Installation Of POD Facility To CAR-T Drug Manufacturer 4/29/2020

   In late 2018, G-CON began working with a global pharmaceutical company whose goal was to scale up their manufacturing operations in the US and Europe for an approved CAR-T product. Read how G-CON’s POD technology provided a solution in this schedule driven project.

2. Subvisible Particulate Matter Testing 8/31/2020

   This application note demonstrates the capabilty of advanced, automated systems for subvisible particle testing in injections, ophthalmic solutions, and lipid emulsions. 

3. Considerations For Upstream Biologic Development 11/12/2019

   A biologic candidate's path from DNA to drug-in-vial is long and complex. These considerations might simplify and improve the economics of the process, helping molecules get to market as quickly as possible.

4. Rare Disease: Operationalizing Gene Therapy Trials 10/9/2019

   Even measured against the vast scientific mystery that defines the biotech industry, gene therapy poses extraordinary challenges. This paper explores the history of gene therapy trials, as well as the types of gene therapy vectors and delivery strategies. Also discussed is the regulatory and operational challenges associated with gene therapy trials, including start-up regulations, site selection, recruitment, and retention.

5. Extractables Testing On Single-Use Connectors 7/2/2019

   Appropriating BPOG testing on single-use connectors to mitigate the risks of E&L, as demonstrated in this article, is crucial to delivering safe and effective drugs.

6. Industry 4.0 Connects Machines And Data 10/26/2018

   By applying remote monitoring, advanced modeling, and optimization of manufacturing processes, Industry 4.0 offers process reliability and product quality through connecting machines and data.

7. The Insource Vs. Outsource Dilemma 2/21/2020

   Prior to making critical capacity decisions, a small biotech company completed an economic evaluation of manufacturing options to ensure it was selecting the best strategy for its manufacturing. Discover the critical elements of this analysis that may help to balance your assessment.

8. Best Practices For A Successful Bioprocess Technology Transfer 9/10/2019

   A well-executed bioprocess technology transfer is critical to ensure smooth knowledge transfer and optimal process reproducibility. 

9. Updated US FDA Guidance For The Gene Therapy Industry: Key Changes And Areas Of Increased Focus 6/17/2020

   In January 2020, the United States Food and Drug Administration (FDA) released several new or updated guidance documents pertaining to human gene therapy products. This paper summarizes several key changes that will impact developers of gene therapies.

10. Developing A Closed Connected Single Use mAb Purification Process 9/28/2020

    Pharmaceutical manufacturers are striving for more diversified portfolios targeting a greater number of monoclonal antibodies (mAb), the key to driving down overall costs is to lower capital expenditure (CAPEX) investments by better utilization of equipment. This article provides an overview of a successfully designed a closed and physically connected mAb process at the pilot scale with single-use components.