pharmaphorum

FEBRUARY 18, 2021

Researchers from the University of Texas Medical Branch based their findings on lab tests using SARS-CoV-2 coronaviruses that were genetically engineered to have the same mutations as those in the strain that is causing scientists so much concern.

Immune Response 52

Immune Response Genetic Engineering Vaccination Vaccine 52

pharmaphorum

AUGUST 19, 2020

Some highlights on the 2020 agenda: Nicholas Poirier , Chief Scientific Officer, OSE Immunotherapeutics will explore a novel ‘don’t eat me’ target regulating macrophages phagocytosis and dendritic cell antigen presentation.

Genetic Engineering 52

Genetic Engineering Engineer Genetics Antibody 52

XTalks

MARCH 18, 2024

By genetically editing microorganisms, scientists can now manipulate the metabolic pathways to produce foods with desirable properties. The precision fermentation study highlights how genetically engineered microorganisms can inhibit the growth of foodborne pathogens.

Genetic Engineering 52

Genetic Engineering Genetics Production Protein 52

Roots Analysis

AUGUST 31, 2023

An additional level of genetic control is provided by gene switches that are located upstream of the promoter region. These genetic switches assist transcription factors in binding to the promoter region. Negative Gene Regulation: Repressor is a protein molecule that initiates negative regulation.

Gene 40

Gene Gene Therapy Gene Expression Regulation 40

ACRP blog

OCTOBER 8, 2024

Food and Drug Administration (FDA) has released two Notices of Proposed Rulemaking (NPRMs), the initial public notice of a proposed change to federal regulations. The Common Rule was revised in 2018, and the FDA’s two recent NPRMs will harmonize the FDA regulations with most of those 2018 revisions. What is the Single IRB Mandate?

Regulation 59

Regulation Research Engineer Compliance 59

Advarra

JANUARY 11, 2024

Personalized medicine using genetic resequencing techniques, such as cell and gene therapies, enables researchers to create more customized therapies for combatting cancer. Monoclonal Antibodies Monoclonal antibodies are lab-engineered immune system proteins.

Vaccination 52

Vaccination Vaccine Protein Antibody 52

Advarra

AUGUST 10, 2023

“I am very excited for the field because I feel like we’re beginning to get to a critical mass, where a single method or product can be deemed safe and then adapted for many uses,” said Dr. Peter Marks, head of FDA’s CBER – the organization responsible for regulating gene therapies.

Gene Therapy 52

Gene Therapy Development Gene Drugs 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

pharmaphorum

SEPTEMBER 13, 2022

The following year, the regulator also approved Rituximab, a monoclonal antibody targeting CD-20 positive B-cells, as a companion treatment of chemotherapy in older diffuse large B-cell lymphoma patients. Since then, it has transformed the treatment of chronic myeloid leukaemia and non-Hodgkin’s lymphoma.

Genome Project 98

Genome Project Genome Genomics DNA 98

Roots Analysis

OCTOBER 22, 2023

RNA therapeutics are a novel class of biopharmaceuticals that harness the power of RNA molecules for the treatment and prevention of a wide range of disorders, including oncological, and genetic disorders as well as infectious diseases. These therapeutics are broadly classified into two categories, namely coding RNAs and non-coding RNAs.

RNA 40

RNA Protein Genetics Gene Expression 40

WCG Clinical

MAY 28, 2024

CAR-T Cells Target Harmful B Cells in Lupus CAR-T cell technology, which uses genetic engineering to direct white blood cells to attack specific molecular targets, was originally proposed for treatment of HIV infection and hematological malignancies.

In-Vivo 40

In-Vivo Clinical Trials Clinical Trials FDA Approval 40

The Pharma Data

JULY 27, 2021

This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Furthermore, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities.

Production 52

Production Antibody Sales Development 52

The Pharma Data

SEPTEMBER 8, 2020

Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.

Vaccination 52

Vaccination Vaccine Containment Clinical Trials 52

The Pharma Data

SEPTEMBER 8, 2020

is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs. For more information, visit. www.novavax.com. and connect with us on.

Vaccination 52

Vaccination Vaccine Containment Clinical Trials 52

XTalks

SEPTEMBER 15, 2022

According to the order, it will improve and expand biomanufacturing production capacity and processes, train a biotech workforce, expand market opportunities for these products and streamline regulation. Related: Top Food Industry Regulations to Watch in 2022. Here’s everything you need to know.

FDA Approval 95

FDA Approval Genetic Engineering Genetics Production 95

XTalks

DECEMBER 3, 2024

The first genetically engineered human insulin , Humulin , was introduced in 1982. It stands out by targeting the GIP receptor, complementing the effects of GLP-1 to improve insulin regulation and blood sugar control. The primary function of the drug is to regulate glucose metabolism. for a 10 mL vial.

Sales 105

Sales Insulin FDA Approval Drugs 105

Roots Analysis

JANUARY 27, 2025

Microorganisms can be genetically engineered to produce complex biologics with high efficiency and lower costs. Regulatory Considerations: The production and approval of microbial fermentation products are heavily regulated to ensure safety, efficacy, and quality. Key Growth Restraints 1.

Marketing 40

Marketing Manufacturing Production Development 40