article thumbnail

Cyfendus Anthrax Vaccine Wins FDA Approval

XTalks

Emergent BioSolutions, a multinational specialty biopharmaceutical company headquartered in Gaithersburg, Maryland, has achieved a significant milestone with the approval of its Cyfendus (Anthrax Vaccine Adsorbed, Adjuvanted) vaccine by the US Food and Drug Administration (FDA). How Does Cyfendus Work? mL for intramuscular injection.

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. Excluding vaccines, there are five mRNA therapeutic products in clinical trial development as of November 2022.

Insiders

Sign Up for our Newsletter

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

article thumbnail

DeepVerge’s nanochip-based COVID breath test could be ready this year

pharmaphorum

Now the Ireland-based firm said that early data from studies shows the system can detect and identify the COVID virus S-Protein in quantities at 40 femtograms per millilitre at close to 100% specificity. A femtogram is 0.000000000000000001 kilograms.

article thumbnail

Biologic Therapeutics Development, Part 1: Definition and Distinct Characteristics

Camargo

Section 351 of the Public Health Service (PHS) Act defines a biological product as a “virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product. Biologics include a wide range of products , including: Vaccines. Recombinant therapeutic proteins.

article thumbnail

Advances in cell line development

Drug Discovery World

Grand View Research states that the market for cell lines is currently bolstered by the fact that the majority of biopharma companies use cell lines to synthesise recombinant monoclonal antibodies and proteins. There are a lot of considerations to take when choosing a cell line.

article thumbnail

Quality by design with a focus on biosimilars

Pharmaceutical Technology

There are many variabilities with biosimilars and the brand name protein drug.” Protein-based drugs are extremely expensive and so if you can create a biosimilar and potentially lower the cost, then this is an incentive for many companies to try to get into that marketplace, but also for regulators to encourage development.”.

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. mRNA enables the delivery of a transiently expressed genetic molecule that is translated into a target protein using the machinery of the host cell. Therefore, the risk for off-target insertional mutagenesis is greatly reduced.