• posted by: Lee Smith
• posted on: August 17, 2021

Conducting well-designed structured studies is important when formulating any vaccine. For live viral vaccines, some challenges include limited analytical tools and inherent variability that make evaluation difficult.

• posted by: Lee Smith
• posted on: June 5, 2019

CEPI awards US$21 million to Themis Bioscience

• posted by: Lee Smith
• posted on: February 25, 2019

Chikungunya Vaccine receives FDA Fast Track Designation

• posted by: Lee Smith
• posted on: March 7, 2018

Themis Bioscience GmbH, an Austrian based vaccine company, has secured a $37.5m agreement with CEPI to create new vaccines for the infectious diseases Lassa Fever and MERS-CoV.

• posted by: Lee Smith
• posted on: June 30, 2017

Article titled The State of the Industry as a celebration of BioProcess International’s 15th year of publication

• posted by: Lee Smith
• posted on: April 25, 2017

Takeda has recently finished enrolling 20,100 children for their phase 3 dengue vaccine clinical study in 8 endemic countries after just seven months. The study, that was started back in September 2016, is a placebo controlled study covering two doses of the vaccine each three months apart in children aged from 4 to 16. The aim is to confirm if the vaccine can protect against any dengue serotype of varying severities regardless of previous exposure.

• posted by: Lee Smith
• posted on: March 28, 2017

Several vaccines for Zika virus including a traditional inactivated virus vaccine, as well as newer DNA vaccines have passed animal tests and are now ready for human trials.

• posted by: Lee Smith
• posted on: January 30, 2017

Last October (2016) I posted an article on whether there should be a global vaccine development fund. Therefore, I was very excited to see an announcement made at the World Economic Forum in Davos, Switzerland on January 18th (2017) that a new global coalition had been formed; the Coalition of Epidemic Preparedness Innovations, or CEPI.

• posted by: Lee Smith
• posted on: November 15, 2016

I’ve been working closely with contract manufacturing organisations (CMOs) for many years now.  Some of these have been in the USA, some in Europe and some in Asia.  What they have in common is that all have been a vital component in the development and manufacturing strategy of the organisations that I’ve been working for.   Unsurprisingly, I was generally working with a small and mid-size biopharmaceutical entity (SME) rather than multinational pharma that often have the resources to perform their own manufacturing or testing whereas the smaller companies do not.   If you look at the numbers relating to CMO use in the United States, almost 80% of products approved by the FDA will have been manufactured by a CMO on behalf of a SMEs. This drops to approximately 50% for mid-sized companies.