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Source: COVID-19 Convalescent Plasma and Hyperimmune Plasma Or H-Ig Therapies  Jun 15, 2020  3 years ago
COVID-19 Convalescent Plasma Therapy Soon To Be Superseded By More Effective Hyperimmune Plasma Or H-Ig Therapies
COVID-19 Convalescent Plasma Therapy Soon To Be Superseded By More Effective Hyperimmune Plasma Or H-Ig Therapies
Source: COVID-19 Convalescent Plasma and Hyperimmune Plasma Or H-Ig Therapies  Jun 15, 2020  3 years ago
Convalescent Plasma: In an attempt to treat COVID-19, there have been numerous studies and trials to treat COVID-19 involving convalescent plasma transfusions but most have produced only mediocre results. Biotech companies working in the plasma space are now collaborating to develop a hyperimmune Ig therapy which could product produce better results.

Typically, plasma is the liquid component of blood; though it is 90% water, it also contains salts, enzymes, antibodies and other proteins. It is very useful for blood clotting, regulating the body’s pH levels, as well as fighting diseases.
Takeda’s head of plasma-derived therapies and co-leader of the industry-wide CoVIg-19 Plasma Alliance Dr Julie Kim told Thailand Medical News, “Plasma is an important potential source for therapeutic use in this COVID-19 crisis. When individuals recover from Covid-19, they develop antibodies against the coronavirus, which are present in their plasma. This is known as convalescent plasma.”
At the moment convalescent plasma donations from those who have recovered from Covid-19 are used in transfusions for those sickened by the COVID-19 disease. However a more useful way to use these donated plasma is to develop hyperimmune plasma-derived therapies.
Plasma Protein Therapeutics Association (PPTA) president and CEO Dr Amy Efantis explained, “At the moment convalescent plasma transfusions is used for patients who are very sick. It boosts their immune system and gives them the necessary antibodies to fight the disease. These transfusions are already being performed on emergency authorization in the US, as well as investigated for safety and efficacy in various studies.”
Though these transfusions are an excellent short-term solution, the CoVIg-19 plasma alliance has brought together companies from across the plasma space to research, develop and manufacture so-called hyperimmune globulin (H-Ig) therapies from the plasma donations.
Dr Kim added, “This type of hyperimmune therapy has previously been shown to be effective in treating severe viral respiratory infections. H-Ig therapies were previously employed in the context of epidemics and pandemics, including the 2009-2010 H1N1 influenza virus pandemic.”
In the case of convalescent plasma transfusions, the plasma is simply donated from recovered patients who have been symptom-free for 14 days. It is then screened for viruses and relevant antibodies against SARS-CoV-2 virus that causes Covid-19, and compatibility blood type matching between donors and patients is carried out, before it is transfused directly into a sick patient.
However effective H-Ig approaches would be a real step forward on convalescent plasma infusions in the fight against COVID-19.
For these H-Ig therapies, the plasma is pooled, concentrated and purified, resulting in a vial of medicine with consistent levels of antibodies in each unit that is easy to store, distribute and administer to patients.
Utilizing the manufacturing process, H-Ig therapies are standardized to have a consistent level of virus-specific antibodies. Due to these processing steps, H-Ig therapies do not require blood type matching like plasma transfusions. With plasma transfusions the amount and range of antibodies varies significantly between donors, so it is very hard to deliver a standardized dose.
A current constrain with convalescent plasma transfusion is a lack of scalability.
One cannot treat many individuals with the transfusion approach. With approximately 600 milliliters of plasma, one can treat approximately only three patients.”
Also another drawback is that conventional plasma transfusions have to be used or frozen within 24 hours of collection whereas although the manufacturing process for H-Ig is much more complex, it has a much longer shelf life of 24-36 months.
H-Ig therapies also have a very good safety profile. This because all viruses found in the plasma have been inactivated in at least three dedicated manufacturing steps, therefore reducing the risk of transmitting any viruses, not just SARS-CoV-2, from donors to patients. This safety profile has been proven from plasma-derived therapies’ use in other conditions, such as primary immune deficiencies and hepatitis A and B.
While convalescent plasma is often being used for those who are very ill with COVID-19, H-Ig therapies, on the other hand, have the potential to “provide ‘passive’ immunity to the new coronavirus, as it contains antibodies that help the immune system immediately fight the coronavirus.
This implies these, H-Ig therapies can, like vaccines, be used prophylactically for healthcare workers or those at higher risk of exposure to COVID-19.
In reality these H-Ig therapies can do this faster than vaccines, which confer so-called ‘active’ immunity where the immune system has to develop its own antibodies against the virus over several weeks.
A key theme of the pharmaceutical and biotech industry’s response to the Covid-19 pandemic has been collaboration. Takeda has taken this one step further with its unprecedented partnership with other members of the plasma community to create the CoVIg-19 alliance, which aims to successfully develop an H-Ig against Covid-19.
ADMA Biologics CEO Adam Grossman commented, “The challenges presented by COVID-19 are tremendous and in order to have the reach necessary to meet these challenges, it takes effort, know-how and collaborative discussions, the sharing of past successes and failures to expedite the discovery process and outline a path to produce a potential therapy.”
The biotech company ADMA is another of the ten members of the alliance; it has expertise in the composition and use of an Ig for the prevention and treatment of a respiratory tract infection.
The CoVIg-19 alliance by collaborating has been able to ramp up donation collection of convalescent plasma. This is the biggest challenge facing all plasma products. They have started an international awareness campaign about the need for plasma and to encourage people to donate called “The Fight Is In Us“.
Furthermore the alliance has been supported by other companies outside of the plasma space, such as Microsoft and Uber Health. The former’s Plasmabot helps potential donors quickly and easily find information about donating and their local collection centre, while Uber Health has donated 25,000 round-trip rides to take donors to and from those centres.
The alliance is now seeing some good momentum in collection and already has sufficient volumes to start clinical manufacturing, but they collect and the more quickly, the faster they can go and the more they can potentially make.”
One of the silver linings of COVID-19 is that there is raised awareness in the general public about plasma, and hopefully it will be sustainable in the future.
The H-Ig alliance is working with the US National Institute of Allergy and Infectious Diseases (NIAID) to test the safety, tolerability and efficacy of H-Ig in adult patients hospitalized with COVID-19. The study is currently underway and it will set the foundation for future, potential regulatory approvals of the H-Ig therapy.
The H-Ig therapy against Covid-19 would most probably be launched for the general public as early as October 2020.
For more about Convalescent Plasma and Hyperimmune Plasma Or H-Ig Therapies for COVID-19, keep on logging to Thailand Medical News.


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