As manufacturers and other healthcare stakeholders try and chart a course in the emerging gene therapy field, there are many considerations a manufacturer should be mindful of as they plan for a future launch into this emerging space.
- The Rise Of Gene & Cell Therapy And The Resulting Need For In-House Production Facilities: A Guide
- Operationalizing Cell & Gene Therapy: Challenges And Solutions
- Data-Driven Cell Therapy: Reducing Risks And Accelerating Development
- Maintaining Lab Operations Amid Coronavirus Restrictions
- The Future of Regenerative Medicine: 3D Bioprinted Human Lungs
- Removing Barriers To Achieve Widespread Clinical Adoption Of Lentiviral Gene Therapy
- Comparison Of Health Technology Assessments And Time To Reimbursement For Orphan Drugs And Gene Therapies From Four HTA Agencies
- Repurposing An Aging Facility To Produce Cell & Gene Therapies
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
Buffer Composition Effect On Protein Purification
The use of buffer components have significant effects on the purity and recovery of target molecules during the purification step using Nuvia aPrime 4A, a hydrophobic anion exchange resin.
Cell Therapy Scale-Up Strategies For Commercial Success
To achieve commercial success, a developed process must be scalable and suitable for a manufacturing environment. The scaling strategy depends on the type of cell therapy. This article discusses options for cell therapy process development and validation that minimize risks through quality control (QC), optimization, scaling, closing, automation, and assay development, all in order to prepare for successful commercial production.
Understanding The CMC Regulatory Landscape For Cell And Gene Therapy Products
The curing potential of cell and gene therapies is driving the industry’s passion and motivation to gain a better understanding of the evolving regulatory guidelines for these products, in order to bring them to market faster.
Considerations For Bioreactor Process Development And Scale-Up For Transient Transfection-Based Lentivirus Production In Suspension
Several challenges are associated with use of an adherent platform for lentivirus production. This white paper describes considerations for suspension-based, transient transfection bioreactor process development and scale-up of lentivirus production. We will describe the approach taken for process development.
Reducing The Risk During Cell And Gene Therapy Development And Manufacturing
While these new modalities are generating significant excitement among patients and caregivers, cell and gene therapy manufacturers are experiencing growing pains. The rapid growth and continued momentum of the industry has led to the issuance of new guidance. In this article we share insights for navigating within a novel and complex regulatory environment, mitigating risks posed by raw materials and implementing proper risk assessments during manufacturing.
Local Lab Normalization
Local laboratory data normalization is a routine process in clinical trial data management. However, even with standardized collection and transport procedures across the laboratories there is often variability to account for. This paper highlights the modern need for access to local laboratory data in near real time.
Single-Use Fluoropolymer Bags For Efficient High-Density Cell Banking
This paper explains how single-use bags perform during freezing, storage, and thawing steps and why they present an efficient alternative to vials in a variety of upstream cell banking applications.
A Global Observational Registry Of Adult Patients With Homozygous Familial Hypercholesterolemia (HoFH)
Clinical development service provider efficiently and strategically manages a global rare disease registry with rolling start-up, including mandated annual data collection and reporting.
How To Speed Up Cell And Gene Therapy Treatments For Patients, Reduce The Number Of Manual Operations And Eliminate Operator Errors
This white paper addresses the unique production problems of cell and gene therapy and explains how a manufacturing execution system (MES) can address them. It provides guidance on how to select an MES and a case study of two CAR-T therapy companies scaling up with and without an MES.
Robust Field Guide To qPCR
qPCR remains the gold standard for validation of microarray and next generation sequencing data and the method of choice for both clinical and basic research labs for a wide range of applications. However, there remains general concern about the production of data that truly reflects the tested experimental conditions. We have developed a comprehensive guide to performing the ultimate qPCR experiment. The following is a snapshot of the critical steps needed to achieve excellent results.
CELL AND GENE CONTENT COLLECTIONS
The novel cell and gene therapies in the development pipeline today are the result of years of pioneering research by world-class, U.S.-based academic universities and biopharmaceutical research companies. The development of cell and gene therapies has become an essential component of cancer and genetic disease research and treatment. As such, there has been a great deal of financing funneling toward cell and gene therapy research, with companies raising nearly $2.6 billion in the third quarter of 2019. Provided are articles that help pose and answer questions around the research element of cell and gene therapy.
More Content Collections
CELL & GENE INDUSTRY EVENTS
Patient-to-Patient Supply for Cell Immunotherapies Summit
October 29 - 30, 2020
China GCP 2020: Understanding and Implementing New Compliance Requirements
October 29 - 29, 2020
11am-12:30pm EDT, Online Training
Festival of Biologics
November 2 - 6, 2020
December 7 - 9, 2020