Advarra

JUNE 13, 2024

When working with an unfamiliar IP, clinical personnel are likely looking for answers to three main questions: What are the risks associated with this IP? Replication-incompetent Agents Many viral vectors used in clinical trials today are genetically engineered with safeguards to render them replication-incompetent.

Genetic Engineering 52

Genetic Engineering Clinical Trials Clinical Trials Engineer 52

Advarra

MARCH 31, 2023

This trend came to the forefront during the COVID-19 pandemic, as the three most popular vaccines developed in response to the coronavirus contained engineered genetic materials in the form of mRNA or a genetically engineered virus.

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. IBC membership must include involving two local community members who reside within 50 miles of the research site.

Genetic Engineering 98

Genetic Engineering Gene Therapy Genetics Engineer 98