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

Advarra

JUNE 12, 2023

IBCs, however, seek to protect study personnel, the community, and the environment from exposure to engineered genetic material and other biohazardous agents. IBCs include members who possess expertise in genetic engineering, biological safety, infectious diseases, and environmental protection. What Does an IBC Review?

Genetic Engineering 98

Genetic Engineering Gene Therapy Genetics Engineer 98

WCG Clinical

NOVEMBER 17, 2023

Since then, however, certain genetic engineering technologies (e.g., For example, two trials testing genetically identical genome-edited cell therapies – one engineered with a viral vector, and one without – can differ in their IBC review requirements because of how the cells were modified rather than what they have become.

Genome 52

Genome Genomics Gene Editing Genetic Engineering 52

Pharmaceutical Technology

JUNE 29, 2022

We also benefit from having cGMP manufacturing capabilities in compliance with global regulatory requirements, a strong heritage from our mother company’s brand, a proven track record of reliable and secure supply, and a new partner that is probably the best player in the market within enzyme diversity.

Drugs 295

Drugs Gene Therapy Manufacturing Production 295

Advarra

JANUARY 11, 2024

Some of these approaches involve directly isolating the patient’s immune cells and simply expanding their quantity, while other treatments involve genetically engineering their immune cells to enhance cancer-fighting capabilities. Monoclonal Antibodies Monoclonal antibodies are lab-engineered immune system proteins.

Vaccination 52

Vaccination Vaccine Protein Antibody 52

Advarra

OCTOBER 26, 2023

Controlled Environment and IP Containment The potential for a release, and the risk associated with a genetically engineered IP, are part of the IBC’s assessment purview under National Institutes of Health (NIH) Guidelines.

Production 52

Production Containment Biohazard Biohazard 52

Cloudbyz

MARCH 5, 2024

Administration and Dosage: Due to their nature, biologics are often administered via injection or infusion, which can affect patient compliance and convenience. Ensuring batch-to-batch consistency is a significant challenge. Determining the optimal dosage and administration route is more challenging.

Development 78

Development Drugs Manufacturing Immune Response 78