Advarra

JUNE 13, 2024

Recombinant DNA technologies and genetically modified biological agents are being adapted for a wide scope of therapeutic applications, and their use is becoming increasingly common in clinical trials. Synthetic mRNA-based therapeutics used in clinical research today also fall into this self-limiting class of recombinant therapeutics.

Genetic Engineering 52

Genetic Engineering Clinical Trials Clinical Trials Engineer 52

Advarra

MARCH 31, 2023

The use of engineered genetic materials in clinical trials is rapidly expanding, with potential applications for genetic vaccines, gene-modified cellular therapies, and gene therapies. A key part of the IBC’s evaluation is assessing the risks posed by the engineered genetic materials.

Engineer 52

Engineer Genetics Clinical Research Research 52

WCG Clinical

NOVEMBER 17, 2023

At the time this change was implemented, methods used to deliver rsNA to cells or research participants typically involved the use of viral vectors that were subject to the NIH Guidelines. Since then, however, certain genetic engineering technologies (e.g.,

Genome 52

Genome Genomics Gene Editing Genetic Engineering 52

Advarra

JANUARY 11, 2024

The applications of mRNA-based therapies in cancer research represent one of the next groundbreaking steps toward improved cancer treatments. While mRNA usage has played several roles in clinical research , oncology researchers in particular are eager to explore the possibilities of mRNA-based cancer vaccines.

Vaccination 52

Vaccination Vaccine Protein Antibody 52

Cloudbyz

MARCH 5, 2024

The complexities in clinical research in both Clinical research for both biologics and small molecules involves complex processes that are crucial for demonstrating safety, efficacy, and quality before obtaining regulatory approval. Ensuring batch-to-batch consistency is a significant challenge.

Development 97

Development Drugs Manufacturing Immune Response 97

Advarra

JUNE 12, 2023

Gene therapy research is exciting and full of promise, but because of the risks involved, it’s also highly regulated, requiring an institutional biosafety committee (IBC) to provide additional oversight and risk assessment. The IBC also reviews to confirm a comprehensive risk mitigation plan is in place prior to starting the research.

Genetic Engineering 98

Genetic Engineering Gene Therapy Genetics Engineer 98