Recently appointed to the permanent CDER director role, Dr. Cavazzoni’s appointment was not unexpected, as she was recruited to join the FDA in 2018 from a senior industry role and served as acting CDER director at the start of the agency’s pandemic response. Her experience suggests she will continue to evolve – rather than revolutionize – FDA’s drug review policies.
- Rare Diseases: How To Leverage Social Media For Patient Analysis
- FDA Releases Guidance On CMC Changes To An Approved Application: Certain Biological Products
- Designing A Patient-Centric Digital Ecosystem: Strategies For Cell And Gene Therapy CxOs
- How To Enhance “Operational Learning” In Biopharma
- The Cumulative Risk Of Multiple CT Scans on Blood Cancer Patients Enrolled In Clinical Trials
- Navigating DSCSA Implementation: Key Requirements & 4 New FDA Guidances
- The Importance Of Feasibility Assessments In The Standards Development Process
- PIC/S Annex Update: What Is Your ATMP Control Strategy?
CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
Scale-Up Of CHO Cell Fed-Batch Cultures
This application note compares cell growth and recombinant protein production of multiple CHO cell clones when cultured in HyClone ActiPro basal medium and Cell Boost 7a and 7b feeding supplements.
Enabling Broader Adoption Of Process Intensification In Biopharma
PI is becoming increasingly well-understood and its utility is continuously evolving to meet specific manufacturer needs, from product development to manufacturing, whether approached stepwise or end-to-end.
Osmolality As A Concentration Measurement Method For Key Buffers In Bioprocessing
The manufacturing of biologics is a complex and costly process by which a protein is recovered and purified of contaminants to ultimately generate a drug product. This is accomplished through a chain of filtration and chromatography processes. This study was conducted to understand how osmolality can serve as a concentration measurement and how it compares to pH and conductivity measurements.
Quantification Of Vector Genomic, Residual DNA In Gene Therapy Vectors
Bringing cell and gene therapy drugs to market requires improvement in many areas, including analytical testing methods, which are used to determine the safety, strength, and purity of viral vectors.
Cell And Gene Therapy Definitions For Raw Materials, Starting Materials, Drug Substance And Drug Product
The complexity of processes to manufacture cell and gene therapy medicinal products can cause confusion around definitions of raw materials, starting materials, process intermediates, drug substance and drug products. This document will discuss the definitions of the above process components.
Single-use Bioreactors For Platform Scalability
Adoption of single-use bioreactor platforms across all scales, ranging from benchtop to production, are becoming increasingly popular due to their ease of use and operational flexibility.
Choose The Right FDA Program To Expedite Your Rare Oncology Trial
With their poorly understood natural histories, phenotypic heterogeneity, and diverse clinical manifestations, rare cancers pose challenges to drug development and represent a significant unmet need in oncology. Faced with limited treatment options, researchers, clinicians, and patients may be seeking approaches to accelerate the development and approval of novel therapies. In this blog post, we review the regulatory programs available to expedite treatments for rare disorders and serious diseases.
Avoid Costly Mistakes In Gene Therapy Process Development
Success in the evolving and highly competitive gene therapy space requires navigating many uncertainties related to process development and manufacturing of adeno-associated virus (AAV) and lentivirus vectors. These tips will guide development and manufacturing teams operating on compressed timelines.
Peptones: Established Supplements For Vaccine Applications
Vaccine development can be complex and expensive. Improving your development process—from cell growth to viral production—through reduced costs and increased efficiencies may, therefore, be vital for your success. Peptones can offer a solution. Rich in amino acids, peptides, vitamins, carbohydrates, nucleosides, minerals, and other components, peptones are well suited for use as supplements and feeds. To help you learn more about the potential that peptones hold, we’ve outlined four ways that peptones could benefit your vaccine development processes.
Liquid Nitrogen-Free Cryopreservation For Sustainability
This study focuses on the running costs and carbon emissions associated with cryopreservation equipment, comparing a liquid nitrogen (LN2)-free controlled-rate freezer with a typical liquid nitrogen-based system. The environmental implications of using liquid nitrogen for cell freezing are explored along with carbon emissions during the manufacture, transportation, and operation of LN2-free controlled-rate freezers.
CELL AND GENE LIVE
In this on-demand webinar Cell & Gene Chief Editor Erin Harris talks with Dr. Mark Gilbert, SVP of R&D at Acepodia, Thomas Lequertier, Head of Cell Therapy Manufacturing Unit at Celyad Oncology, and Luděk Sojka, Ph.D., Chief Technology Officer at SOTIO, about the innovations in manufacturing that can reduce both costs and risks.Cell & Gene Live On-Demand
CELL AND GENE CONTENT COLLECTIONS
As the industry emphasizes its commitment to rare disease patients, gene therapy is an attainable opportunity to improve the lives of patients who have complex diseases with significant unmet needs. We’re happy to share with you original, actionable editorial that illustrates the sector’s commitment to advancements in gene therapy.More Content Collections