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. Why Does the IBC Need to do a Risk Assessment?

Engineer 52

Engineer Genetics Clinical Research Research 52

WCG Clinical

NOVEMBER 17, 2023

Originally released in 1976, the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules ( NIH Guidelines ) serve as the foundation of biosafety-focused oversight of research involving recombinant or synthetic nucleic acids (rsNA). 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 77

Development Drugs Manufacturing Immune Response 77

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. IRBs are tasked with protecting research subject’s rights and welfare. How are IBCs Different from IRBs?

Genetic Engineering 98

Genetic Engineering Gene Therapy Genetics Engineer 98