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

1. 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.

2. Getting Creative: A Hybrid Answer When The Conventional Won’t Do 3/2/2020

   A small oncology-focused biotech company presented such a challenge when seeking to contract out its data management services. This CRO combined outsourcing, insourcing, and geographic flexibility to devise a hybrid solution.

3. Quality Matters – SEC Analysis For Antibody Aggregates 10/25/2019

   Size exclusion chromatography is the go-to analytical method for therapeutic protein drugs. This article describes the factors affecting the reproducibility of columns and how you can minimize column variation.

4. Adenovirus Production In Single-Use Bioreactor System 3/8/2019

   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 such a system.

5. What You Need To Know About Process Characterization And Validation For Biologic Processes 4/3/2020

   Process characterization and validation can be challenging, but using a risk-based approach to generate an appropriate control strategy will help assure your product meets these requirements, enabling timely approval and launch to market.

6. Optimizing Process Efficiency In Upstream Manufacturing 2/8/2019

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

7. Cold Chain Qualification: 5 Questions You Must Ask When Shipping Biologics 2/11/2019

   Organizations recognize the growing need for control of the entire cold chain as the changing global scenario requires highly efficient processes and flexibility.

8. 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.

9. Expanded Droplet Digital PCR Multiplexing Capability Using Two Different Strategies 10/23/2019

   Droplet Digital PCR (ddPCR) enables easy multiplexing of numerous targets within each fluorescent channel. Amplitude-based multiplexing achieves this by varying primer and/or probe concentrations. In probe-mixing multiplexing, probes are mixed at desired concentrations to place targets in a defined position on a 2-D plot. This paper describes strategies for both approaches using the large portfolio of ddPCR Assays readily available through Bio‑Rad.

10. Adenovirus Production In Single-Use Xcellerex™ XDR-10 Bioreactor System 9/10/2018

    This application note describes the production of adenovirus in HEK293 cells cultured in HyClone™ CDM4HEK293 culture medium.