With several gene and cell therapies currently in development and even more rapidly moving toward the development stage, a big bottleneck in this evolving field is identifying sites with the capability and capacity to conduct these resource-intensive studies.
- Reflecting On The Meaning Of Our Work In Gene Therapy
- COVID-19 And Beyond: Perspectives From A Regulatory Affairs Professional
- Contingency Planning For Quality In The Cell And Gene Sector Due To COVID-19
- Regenerative Medicine Research & COVID-19
- Partly Cloudy And Chance Of COVID: Bringing The Umbrellas And Raincoats For Cell And Gene Therapy
- What The Gene Therapy Sector Doesn’t Understand About CRISPR
- Understanding the Three Major Challenges Limiting Innovation In Tissue Engineering
- A CLL/CAR-T Story — A Patient’s Perspective
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
Comparator Local Sourcing For Clinical Trials
This growing demand for comparators is causing many supply chain managers to explore available sourcing options. This paper examines the fundamentals of local sourcing, including the benefits and challenges of sourcing locally, and the circumstances under which local sourcing can be a sound decision. Recommendations are provided for avoiding common pitfalls in implementing a local sourcing strategy.
Controlled Endpoint In Cryopreservation
Successful cryopreservation of cells requires a controlled cooling rate. Cooling too rapidly or too slowly could lead to a poorer outcome. This application note demonstrates how controlled-rate cooling is achieved using equipment such as VIA Freeze controlled-rate freezers.
CMC Strategies For A Bispecific Antibody Platform For Cancer Immunotherapy
Bispecific antibody development presents many challenges in product expression, bispecific purification, product stability, and scale up of the manufacturing process.
Viral Clearance: The Basics On How To Conduct Effective Studies
Effective viral clearance studies remain one of the challenges facing manufacturers of biologics. These studies are an essential part of process validation and are critical to ensure drug safety. This article provides the basics of what you need to know when studying virus reduction of a chromatography step.
Bioprocess Sampling Case Study
A GMP-compliant, novel process sampling solution for taking multiple conical tube samples at varying time points results in immediate process efficiency and sterility assurance.
Reliable Osmolality Testing Of High Concentration mAb Formulations
Osmolality testing has several bioprocessing applications, and new use cases are constantly emerging. This paper evaluates two osmometers for measuring concentrated protein formulations.
Pluripotent Stem Cell Expansion And Scale-Up
Upstream process development is complex for stem cell therapies, because these therapies involve many manipulations during cell differentiation or even cell engineering. Decisions made early in research will impact the entire product life cycle, so it is important to consider a good process design early on.
Addressing New Chromatography Challenges With Fiber Absorbents
An absorbent material using a novel proprietary structure overcomes the diffusional and flow limitations of packed bed chromatography purification systems and aims to address the capacity issues.
Osmolality Is A Predictor For Model-Based Real Time Monitoring Of Concentration In Protein Chromatography
The bottleneck for real time control and real time release is lack of product-specific in-line sensors or fast at-line
methods suitable for model-based prediction of process outcome. Learn how osmolality as an at-line method is an excellent predictor together with UV280 and UV260 for protein quantity in model-based prediction using partial least squares methodology.
The Effect Of Rocking Rate And Angle On T Cell Cultures Grown In Expansion Systems
Ensuring optimal and maximal T cell production is critical for adoptive immunotherapy and its continued success. The Xuri Cell Expansion System is an important component of the clinical manufacturing process so we sought to investigate the effect of the rocking rate and angle on the expansion of T cells.
CELL AND GENE LIVE
CRISPR-engineered stem cell research has made tremendous advancements in the past five years, but challenges still exist. To overcome those challenges, industry experts, such as Sadik Kassim, CTO at Vor Biopharma, have dedicated their careers to the scale and manufacturing of CRISPR-engineered therapies.
Check out our discussion with Sadik on the benefits, the challenges and feasible solutions, what’s next, and more.Cell & Gene Live On-Demand
CELL AND GENE CONTENT COLLECTIONS
Even though cell therapy and gene therapy are overlapping fields of biomedical research, there are differences between them that are germane to each. Cell therapy has challenges and risks all its own. For your reference, here are some of the latest articles that will help you better understand the benefits, risks, costs, and more associated with cell therapy.More Content Collections