article thumbnail

Quality by design with a focus on biosimilars

Pharmaceutical Technology

Even minor amounts of biological contaminants in your sample could cause unwanted biological effects,” Dr Amiji says. coli, where small amounts of contaminants could cause significant toxicity. For example, the Covid-19 pandemic brought messenger ribonucleic acid (mRNA) vaccines into international prominence.

article thumbnail

Risk Assessment for use of Engineered Genetic Materials in Clinical Research

Advarra

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. Gene Delivery Systems Genetic material, in the form of DNA or RNA, does not easily enter cells without the aid of a delivery system.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Scientists engineer safe, virus-resistant E coli for research

Drug Discovery World

The work promises to reduce the threats of viral contamination when harnessing bacteria to produce medicines such as insulin as well as other useful substances, such as biofuels. The team used two safeguard methods to prevent the bacteria and their modified genes from escaping into the wild.

article thumbnail

Unlocking the potential of mRNA for the future treatment of rare diseases 

Drug Discovery World

mRNA technology helped us to vaccinate the world against SARS-CoV-2. At this stage, qPCR can be used to check for IVT efficiency, residual DNA contamination and adventitious agents such as microbes. Approximately 7,000 rare and ultra-rare diseases have been described, and yet, 90% have no approved therapeutic options 1.

article thumbnail

Biopharmaceutical Filtration: A Deep Dive

Roots Analysis

Biopharmaceutical filtration is a critical step in the production of biopharmaceuticals, including proteins, antibodies, and vaccines. It involves the separation of unwanted particles from biological materials to obtain contaminant free products. Particle Removal: This is the primary function of these filtration systems.

article thumbnail

Can your LNP manufacturing platform cope with the pace of the mRNA revolution?

Pharmaceutical Technology

The successful development and deployment of the mRNA-based COVID-19 vaccines has catalysed the biopharma industry and paved the way to expand this drug modality to new therapeutic areas. GlobalData pharmaceutical analysts project that RNA-based gene therapies for oncology will grow from zero in 2022 to $4.6 billion by 2028.

article thumbnail

COVID-19 Pandemic Coverage

XTalks

Vaccine Nationalism” Could Prove the Undoing of COVID-19 Containment. Tension is mounting as nations big and small jockey around industry to ensure they are first in line to access a vaccine, should one prove to be successful against COVID-19. Moderna’s COVID-19 Vaccine. The price of that prize is incalculable.