From The Editor | December 14, 2020

COVID-19 Consortium: Competitive Collaboration On A Plasma-Derived Therapy

mattpillar-aboutus

By Matthew Pillar, Editor, BioProcess Online

All Hands In

A host of global biopharma competitors are collaborating under the CoVIg-19 Plasma Alliance to secure enough convalescent plasma to produce an effective COVID-19 therapeutic at global scale. Takeda’s Dr. Thomas R. Kreil will present at the upcoming FDA/Xavier PharmaLink Conference.

For more than 20 years, Thomas Kreil, Ph.D. has been applying his expertise in pathogen safety to a sequence of biopharma companies including Baxter Biosciences, Baxalta, Shire, and now Takeda. Over the course of those two decades, he’s continually occupied the very same office space in Vienna, Austria, which is where I recently caught up with him. Dr. Kreil’s longevity is a testament to his value. He’s retained director, senior director, and VP of global pathogen safety roles through multiple big-money mergers and acquisitions, riding the burgeoning biologics market to his current position as Associate Professor of Virology and Vice President, Global Pathogen Safety at Takeda.

A Career Dedicated To Biologics Safety

A biochemist by training, most of Dr. Kreil’s post-academic modus operandi has been ensuring the avoidance of viral transmission events through biological drug products, such as those seen with plasma-derived products during the early 1980s. It was soon after gaining first recognitions for his work in the field, at a meeting of the Austrian Hemophilia Association more than 20 years ago, that Dr. Kreil experienced a career-defining interaction. He had just wrapped up a presentation at the conference when a woman approached him. “You’re the one from Baxter?” the woman asked him. “Yes,” he replied, anticipating a commendation for his presentation.

Dr. Thomas Kreil, VP & Global Head, Pathogen Safety, Takeda
Dr. Thomas Kreil, VP & Global Head, Pathogen Safety, Takeda

“The woman pulled a picture of a boy from her purse,” Dr. Kreil recalls. “She said, this was my son. He died from an infectious disease complication associated with products similar to those you’re bringing to the market right now. That was the moment that I truly understood what my job was,” he says. “My work is for people like this boy.”

The work Dr. Kreil and his team does for these people—patients and their families—is complex. Takeda operates more than 30 manufacturing sites globally. They must ensure that the biologic products coming out of those sites are pathogen-free. For every biologic produced in those globe-spanning sites, Dr. Kreil’s team can replicate the manufacturing process, albeit on a smaller scale, in their Vienna lab. Then, in the biocontainment lab they grow viruses— to titers often higher than found in the natural world. “Then upstream of the manufacturing process under investigation, we introduce as much of a virus as we can to the biologic we’re producing and study how the process inactivates or eliminates those viruses,” he says. Continually testing those limits in the lab at Takeda’s Global Center of Excellence has only one goal - to ensure that the final biologic products coming out of the company’s many global manufacturing sites, which included plasma-derivatives, recombinant proteins, and cell and gene therapies, will never put a patient in danger of viral infection.  

And Then Along Came COVID-19

In early March 2020, Takeda announced its work on TAK-888, an anti-SARS-CoV-2 polyclonal hyperimmune globulin (H-IG) being developed to treat infected, high-risk individuals with COVID-19. The project would leverage Dr. Kreil’s expertise in an unprecedented way.

Production of a potential plasma-derived therapy to treat COVID-19 depends on the company’s ability to safely source plasma from people who have successfully recovered from COVID-19. These convalescent donors developed antibodies to the virus that could potentially mitigate the severity of illness in COVID-19 patients. “When we launched into the project, we were quite hopeful that we would be able to produce this therapy very quickly,” says Dr, Kreil. “And then, we realized how bad the pandemic was really going to be. Even Takeda, which stands among the top ten pharmaceutical companies on the planet, was no match for the scale of this disease.”

An Alliance Of Competitors With A Common Cause

Realizing the monumental task we faced, leadership at Takeda decided to displace competition with collaboration. “We called on our competitors to bring together our expertise and infrastructure to do two things; accelerate the development of the therapy, and provide the therapy on a broader scale,” Dr. Kreil explains. The resulting collaboration of Takeda, CSL Behring, Biotest, BPL, LFB, and Octapharma marked the launch of the CoVIg-19 Plasma Alliance. Since its inception, the group has grown to include BioPharma Plasma, GC Pharma, and Sanquin. The Bill & Melinda Gates Foundation provides advisory support, and Microsoft provides technology including the Alliance website and the Plasma Bot for donor recruitment. Uber Health provides transportation for convalescent donors.

“Every company that wanted to join forces with us to make sure we could provide this potential therapy more rapidly, and on a broader scale, provide this therapy was invited to join the Alliance,” says Dr. Kreil.

One immediate benefit of the collaborative effort, among many, is expanded access to convalescent donor plasma. While Takeda operates more than 140 BioLife Plasma Services donation centers in the U.S., together, Alliance members have expanded that network to > 500 plasma donation centers.

By October 8th, the consortium of companies were participating in a global clinical phase three trial run by NIAID, part of the NIH. It’s a unique arrangement in that that four different hyperimmune globulin medicines from four different manufacturers are being evaluated simultaneously, albeit on slightly different antibody concentrates, or IgG manufacturing platforms. The final products, however, adhere to a singular critical quality attributes based on their capability to neutralize the SARS coronavirus 2. “In early 2021, we hope to have the results from that phase three clinical trial available, at which time we'll work with regulators to see how we make this most effectively available to those in need,” says Dr. Kreil.

Dr. Kreil To Present On The CoVIg-19 Plasma Alliance At FDA/Xavier PharmaLink Conference

The seemingly altruistic collaboration will be the subject of a talk Dr. Kreil will offer at the FDA/Xavier Health PharmaLink Conference in March, 2021.

In his presentation, Dr. Kreil will likely discuss pathogen safety work over the course of the previous two decades that laid the foundation for the Alliance’s task at hand. “The safety of the manufacturing platform had already been proven, as our IgG concentrate has been licensed for around 15 years,” he says. “What we've done now, via our ability to grow the new virus in our level 3 biocontainment lab, is to develop the analytics for that critical quality attribute, and that we’ve shared with the Alliance,” he explains. “That’s been foundational for this entire enterprise.”

During his presentation, Dr. Kreil will also address what will come of the Alliance once the product moves beyond the clinic and into commercial production. “Collaboration among competitors is not an easy feat. Competition is in our DNA,” he admits. “But there’s a bigger goal that unites us, and that is the patient need.” Still, there is an endgame. “Presently, we have to be mindful of antitrust considerations. Once we successfully develop the product, there will be no need for us to collaborate anymore. We will have produced a non-branded product under the umbrella of the Alliance, and it will be incumbent on the individual manufacturers involved to seek adequate way for making their product available for the indication of the treatment of COVID-19, if they believe there is still unmet patient need.”

A History Of Biologic Pathogen Safety Leadership

As biologic drug products continue to show transformational therapeutic potential and consume a growing piece of the pharmaceutical market, ensuring their protection from pathogens will only grow in importance. Those charged with these new products and their protection from infectious agents won’t want to miss Dr. Kreil’s presentation, where he’ll draw on a career dedicated to the topic—a career that includes a 15 year chairmanship of the Pathogen and Safety Steering Committee for the Plasma Protein Therapeutics Association. That’s another organization predicated on the concept of collaboration among competitors. “If you’re working in the best interest of the patient, then collaboration to keep them safe is the right thing to do,” he says. “That’s rarely been more apparent than it has been during this pandemic.”

Register for the FDA/Xavier PharmaLink conference here, and don’t miss Dr. Kreil’s presentation.