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
Planning Is Everything - Quality Control Testing in Cell and Gene Therapy
Compliance with quality control (QC) standards is a basic requirement for products manufactured under good manufacturing practices (GMP) conditions. In this post we will explore the main compendial QC tests that ensure cell and gene therapies are safe for use in patients, and important considerations for integrating QC testing into the manufacturing process.
Posted: Oct 30, 2019 10:36:18 AM
How to Scale-Up Lentiviral Vector Production Part 1: Considerations for Upstream Processing
Lentiviral vectors (LVV) are a key component in the production of cell and gene therapies. They are most often used to deliver genetic material that will modify cells and confer therapeutic properties. Today, even with the proliferation of cell and gene therapies in development, LVV is still produced using legacy methods employed in basic research. Overcoming technical challenges in the scale-up of LVV production is a major focus for the industry. Scalable LVV production platforms are critical for manufacturing affordable cell and gene therapies and making them more widely available. For an overview of LVV manufacturing and process optimization considerations see our previous post.
Posted: Oct 29, 2019 1:26:17 PM
How Can a Closed CAR-T Manufacturing Process De-Risk Your Process, Reduce Costs and Improve Efficiency?
In a previous post we introduced chimeric antigen receptor T-cell (CAR-T) therapy - a new form of cancer therapy based on genetically reprogramming the body’s immune system that has been described as a “breakthrough” and “revolutionary” by the medical and scientific communities.
Posted: Oct 24, 2019 3:22:49 PM
IQ, OQ and PQ: Why Are They Important in the Manufacturing of Cell and Gene Therapies?
Understanding the cell and gene therapy (CGT) development process from start to finish often comes down to learning the language. For individuals more familiar with the early R&D steps in this process, terms like IQ, OQ and PQ – associated with later manufacturing steps – may be completely new. To get us started: IQ stands for installation qualification; OQ is operational qualification; and, PQ is performance qualification. Simply put, these are three steps in a validation process that ensures the equipment used in manufacturing works the way it’s supposed to.
Posted: Oct 24, 2019 2:29:24 PM