Essentials of Auditing in the Manufacturing of Cell and Gene Therapies
Our previous posts on quality management systems and steps to ensure your cell and gene therapy (CGT) product is Good Manufacturing Practices (GMP) compliant alluded to auditing in the context of a larger manufacturing workflow. This post provides useful insights into auditing to help clients and contract manufacturing organizations (CMOs) understand this critical aspect.
Posted: Mar 27, 2020 9:56:27 AM
Three Essential Considerations for Cryopreservation of Cellular Therapies
Cryopreservation helps cells survive both cooling to extreme temperatures and thawing back to physiological conditions. Our previous post covered the importance and challenges involved in cryopreservation of cellular therapies.
Posted: Mar 5, 2020 9:02:27 AM
Understanding Cryopreservation of Cellular Therapies
Cryopreservation is the process of using ultra-low temperatures to preserve living cells and tissues for a prolonged time period.
Posted: Feb 13, 2020 2:13:44 PM
Induced Pluripotent Stem Cells – Part 1: Understanding Reprogramming
Stemming (pun intended) from the fundamental question in developmental biology around whether cellular differentiation could be reversed – like many transformative scientific discoveries – identification of induced pluripotent stem cells (iPSCs) was a curiosity-induced accident. In their foundational 2006 study, Takahashi and Yamanaka determined that fully differentiated adult skin cells could be reprogrammed back into stem cells by the over-expression of four genes (Oct3/4, Sox2, Klf4, c-Myc).
Posted: Jan 29, 2020 1:58:32 PM
Road to success: Understanding Good Laboratory Practice for cell and gene therapies
Good Laboratory Practice (GLP) studies are essential for generating nonclinical study data supporting drug product submissions or applications for human use. According to the most basic definition, GLP is a set of principles that can be applied to ensure the quality and integrity of non-clinical laboratory studies. GLP provides a means to standardize the results of pre-clinical studies that come from different labs, in part by imposing increased documentation requirements based on standard procedures. Standardization is the driving force behind GLP.
Posted: Jan 10, 2020 1:36:17 PM
What Are the Benefits of an Automated High-Throughput Screening Process for Custom Cell Culture Media Development?
We are often asked if culture media development can be customized at the discovery stage of the product, and if feasible, how it can be done. In this post, we will outline one approach that can be considered to customize media development for discovery-based processes.
Posted: Nov 21, 2019 10:59:14 AM
Five Steps to Ensure Your Cell and Gene Therapy Product Is GMP Compliant
When we think about cell and gene therapies (CGTs) what most often comes to mind is the early stage scientific innovation responsible for finding new ways to treat diseases. A lot of complex research and testing is performed to confirm Proof of Concept and that the therapy performs as desired.
Posted: Oct 30, 2019 3:59:26 PM
Concentration and Reformulation of Cellular Immunotherapies – A Major Downstream Processing Step
Cellular immunotherapies (e.g. CAR-T cells) are primarily used as an autologous therapy to treat cancer. As such, these therapies are currently generated in small batches for each patient. To generate enough modified cells for a single treatment, cells are expanded in volumes from 1-10 L. In the final step of downstream processing (DSP) for immunotherapies, cells cultured in large volumes must be concentrated and reformulated into smaller volumes (e.g. 20-100 mL) suitable for delivery to patients.
Posted: Oct 30, 2019 3:48:28 PM
Considerations for the Use of Stable Producer Lines in the Manufacturing of Lentiviral Vectors
In an introductory post on lentiviral vector (LVV) manufacturing for cell and gene therapies (CGTs) we touched upon the challenges with transfection-based protocols for producing LVVs at large scale. Here we will take a closer look at the use of stable producer cell lines as an alternative to transient transfection for the manufacture of LVVs.
Posted: Oct 30, 2019 3:04:35 PM
How To Scale-Up Lentiviral Vector Production Part 2: Considerations for Downstream Processing
In Part 1 of our series on lentiviral vector (LVV) manufacturing we covered scale-up of upstream processing steps. In this post we will look at the key steps in downstream processing (DSP). The industry “gold-standard” for recovery of purified and concentrated LVV is 10-20 percent. Improving on this low recovery is an opportunity to reduce the cost of manufacturing and get viral vectors into the hands of researchers who need them.
Posted: Oct 30, 2019 1:57:46 PM