Sartorius supports the development of the first vaccine candidate against the novel coronavirus to enter clinical trials
This article is posted on our Sartorius Blog.
Sartorius, a leading international partner of life science research and the biopharmaceutical industry, has supported CanSino Biologics Inc. (“CanSinoBIO”) and Maj. Gen. Chen Wei’s team at the Institute of Bioengineering at the Academy of Military Medical Sciences (“Institute of Bioengineering”) in China in their development of the first vaccine candidate against the novel coronavirus SARS-CoV-2 to enter clinical trials. CanSinoBIO and the Institute of Bioengineering used Sartorius’ Biostat® STR single-use bioreactor system for the upstream preparation of the recombinant vaccine, thus ensuring the rapid linear amplification of the adenovirus vector (Ad5-nCoV) and ultimately saving time during development.
The Biostat® STR single-use bioreactor system comes with updated BioPAT® toolbox for process monitoring, as well as Flexsafe® STR integrated, single-use bioprocess bags. It has been proven to be used for vaccine manufacturing because it offers rapid scalability and flexibility to adapt to fluctuating demand. The single use bags prevent cross-contamination, and reduce the time needed for washing and sanitation typical in stainless steel bioreactors. As such, the amount of time needed to prepare a vector for a vaccine is shortened from several months to (several) weeks.
“We are pleased that we can help our clients and partners accelerate vaccine development while maintaining compliance with safety protocols, thereby allowing us to contribute to better health for more people,” said Huang Xian, Head of Marketing at Sartorius BPS China. “The Sartorius team is making every effort to quickly allocate the staff and equipment needed to support the early stages of vaccine development during this high-risk period. We hope that Ad5-nCoV will achieve approval as early as possible.”
This is the second collaboration from Sartorius, CanSinoBIO, and the Institute of Bioengineering to accelerate vaccine development. In October 2017, Sartorius’ Biostat® STR50 bioreactor system was used during CanSinoBIO’s and the Institute of Bioengineering’s joint development of a recombinant vaccine against Ebola virus disease. This was the first registered Ebola vaccine in the world.
UPDATE
Sartorius' customer CanSino Biologics announced that its coronavirus vaccine candidate has been approved to enter a Phase 1 clinical trial. The vaccine that Cansino Biologics co-developed with the Beijing Institute of Biotechnology is currently the first novel coronavirus vaccine for COVID-19 that has made to this stage in China.
CanSino Biologics is using Sartorius BIOSTAT STR bioreactors to prepare the clinical samples. Thanks to their joint efforts, Sartorius Chinese sales teams delivered two bioreactors on February 28, 2020 – within a record-breaking 10 days from receipt of the customer's inquiry to installation and final on-site acceptance of the bioreactors. Now preliminary preparation of the vaccine has been completed for mass production.
What happens in Phase I clinical trials?
Clinical trials with patients are approved to start as soon as results from preclinical animal studies show that the vaccine candidate can induce a strong immune response in animal models. CanSino Biologics' preclinical animal safety studies have demonstrated a good safety profile. Therefore, this candidate will now be tested on a small group of volunteers to ensure that the vaccine is safe and will not cause any harmful side effects. Experts will be collecting information on the following:
- The dose or treatment
- When and how often a dose is administered
- Any side effects or problems encountered
Why does a vaccine for everyone take so long to develop?
Clinical trials have to follow certain steps in a defined order. All phases are designed to keep volunteer patients safe. Making sure all the steps are completed helps protect patients and provide accurate test results.
In Phase II, several thousand people are then tested to see whether the vaccine also has the desired effect in humans. In addition, researchers will test which dose a person needs to develop an immune response to the virus.
In Phase III, up to 20,000 people will subsequently be tested. In this phase, research is conducted to find out how the vaccine will affect a large number of people so that the dose can be adjusted even more precisely. In addition, the side effects and risks will also be determined.
