This site uses cookies to improve your experience. To help us insure we adhere to various privacy regulations, please select your country/region of residence. If you do not select a country, we will assume you are from the United States. Select your Cookie Settings or view our Privacy Policy and Terms of Use.
Cookie Settings
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Used for the proper function of the website
Used for monitoring website traffic and interactions
Cookie Settings
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Strictly Necessary: Used for the proper function of the website
Performance/Analytics: Used for monitoring website traffic and interactions
According to Reuters , Kenya, Tanzania, Senegal and Cameroon have either run out of or are close to running out of vaccines to protect children against the deadly rotavirus infection following undisclosed “manufacturing challenges” at GSK. We are witnessing the largest sustained drop in childhood immunisation in a generation.
As we come up on a year and a half of the COVID-19 pandemic, with the global roll out of vaccines slowly gathering pace and big pharma riding high in the opinion charts, the biopharmaceutical sector would do well to learn lessons from the banks. Compliance systems by themselves are not enough. Of course, having rules is necessary.
ATMP facilities are different from conventional pharmaceutical facilities that process other traditional modalities, such as vaccines and monoclonal antibodies (mAbs), and often require heightened segregation and smaller footprints. Viral antigen vaccines. For example: Live vaccine manufacturing. Complete Data Gathering.
You were the chief operating officer (COO) at Viroclinics-DDL before the acquisition, joining Viroclinics-DDL in 2008. The capabilities of Viroclinics and DDL allowed us to rapidly test repurposed drugs, new vaccines and antiviral solutions for the prevention and treatment of patients affected by COVID-19 in 2020.
Jaguar Gene Therapy is building a $125 million facility in RTP to manufacture adeno-associated virus (AAV)-based gene therapies, Beam Therapeutics is constructing an $83 million plant to develop precision medicines, and IQVIA, a CRO, opened an innovation lab in the park in 2021, focusing on bioanalytics, vaccines, biomarkers, and genomics.
During the Covid-19 pandemic, large-scale vaccine production placed unprecedented demand on the parenteral packaging industry. While production volumes have now fallen, future vaccine demand is hard to predict, as booster shots could be needed at any point to control emerging variants.
Further, FDA has utilized a variety of strategies to call attention to safety issues through Dear Doctor letters or other forms of communication, even if directing changes to labeling is difficult. Liability is precisely why the vaccine market shrunk so significantly in the 1980s, going from 26 manufacturers to 4, after lawsuits claiming $3.5
Noteworthy cases were the inadvertent introduction of grade 316L stainless steel into Moder-na’s COVID-19 vaccine by the outsourced manufacturer (ROVI Pharma Industrial Services S. In the Moderna COVID-19 vaccine contamination case, three lots of the five lots affected, totaling 1.63 How Did 75M J&J Vaccines Get Ruined?
To help decrease the risk of shingles, Shingrix vaccine is FDA-approved for adults 50 and older. It is a two-vaccine series and significantly decreases the risk of a shingles outbreak. Asthma is a non-communicable disease that causes difficulty in breathing, and it may cause sharp pain on the right side of the chest.
During the pandemic, the pharmaceutical industry faced challenges in the production of COVID-19 therapeutics and vaccines to meet global demand, as well as mitigation of drug shortages for non-COVID-19-related products, without compromising product quality or patient safety. Published 2008. Published May 2012. Guidance for Industry.
We organize all of the trending information in your field so you don't have to. Join 5,000+ users and stay up to date on the latest articles your peers are reading.
You know about us, now we want to get to know you!
Let's personalize your content
Let's get even more personalized
We recognize your account from another site in our network, please click 'Send Email' below to continue with verifying your account and setting a password.
Let's personalize your content