About once a year, a small group of people living with hemophilia visit Bayer’s West Berkeley facility, where the medication they use is developed and manufactured. Last April, on World Hemophilia Day, Juan Pablo Lopez Padilla and Venkat Reddy toured the manufacturing suites and quality labs, meeting Bayer employees along the way. It’s a day that Bayer workers call inspirational and even emotional.
“Before hemophilia treatments were available, most patients would die in their teens or early 20s, due to disease-related complications,” said Sumeet Rastogi, a senior scientist at Bayer who has worked on development for two of Bayer’s hemophilia treatments.
Rastogi will never forget what one patient in his 50s said on one visit: “Now we get to grow old.”
“To me,” Rastogi said, “this is more than enough motivation for dedicating our lives for these scientific pursuits, to develop such medications for our fellow human beings.”
Hemophilia is the oldest-known hereditary bleeding disorder. Patients lack one of 13 types of vital blood-clotting proteins, making them susceptible to excessive bleeding after even minor injuries. For example, simply walking down stairs may cause a micro tear inside a knee joint that most people won’t even notice. In a hemophilia patient, that tear might cause significant internal bleeding.
Bayer’s Berkeley Biotech team has worked for decades developing and manufacturing several recombinant proteins that replace the missing clotting protein in hemophilia A, called factor VIII. This year, Bayer is marking an important milestone: 30 years of commercially manufacturing these products.
Bayer now serves hemophilia patients in more than 50 countries, producing 1.3 million vials of recombinant factor VIII (rFVIII) annually. Bayer also is a significant supporter of the World Federation of Hemophilia, a global initiative designed to increase access to and improve and sustain care for people with inherited bleeding disorders. And Bayer’s Berkeley employees make up one of the largest teams at the annual Northern California Unite for Bleeding Disorders Walk, coming up Oct. 1.
A commitment to people with hemophilia
Bayer launched its first rFVIII product in 1993 and has continued to innovate, developing four generations of products. That work has had a lasting impact on the Bayer Berkeley team.
Amy Tollner, an associate director in quality control, has worked on these products for more than 24 years and has experienced many of the most significant moments of discovery first-hand. One day during testing, she observed results that indicated the team had found a new cell line that would become a new hemophilia treatment. On another day, she saw results that confirmed the path forward for the next treatment.
“Knowing that my work directly impacts the hemophilia patient community has been motivation to come into work on even the most challenging days,” Tollner said.
The Bayer Berkeley team has many other seasoned employees who have contributed to the development and manufacturing of its current hemophilia treatments. Reyes Tamoni, a senior manager in quality control, started as an intern in manufacturing when she was a student, first at Fremont High School in Oakland, and then at Laney Community College.
“Over the years, listening to our patients’ stories during their visits made me realize what I do matters,” Tamoni said. “It is a great honor to be part of Bayer and this great achievement.”
Amanda Glover, who joined Bayer in 1999 and is a manager who handles documentation and training, said the visits from patients are among her favorite experiences at Bayer.
“It is an amazing feeling being a part of a company that has been able to supply hemophilia medicines to patients all over the world,” Glover said.
Collaborating across the site
Bayer Berkeley employees from every part of the business have contributed to improving the production and manufacturing of these important medicines, setting new standards for protein manufacturing.
Early on, much of the focus was on how to increase manufacturing capacity for greater patient access. The theme of this work was “Every drop counts.”
Alan Goyke, an executive director in manufacturing, remembers when a group of operators and supervisors were challenged to reduce the turnaround times on reactors from 10 days to five days in order to relieve a bottleneck in the cell culture process.
“I’ll never forget one update meeting where the team came to me and said, ‘Hey Alan, what would you say if we got you one-day turnaround?’” Goyke said. “And that just blew me away. We gained the capacity of maybe a hundred days a year.”
In the past few years, the team has also made changes to increase the sustainability of the manufacturing process. In one project, a team worked with a new vendor for the bags Bayer uses to store and distribute the product, which allows for each bag to be used 15 times instead of just four times.
“It was a nice time-efficiency savings as well as an ergonomic win,” said Julene Thudium, a director.
These improvements have delivered significant wins for patients and for Bayer. They also have created opportunities for employees to build successful careers.
Maggie Jimenez, an assistant supervisor for the packaging department, has worked at Bayer for more than 26 years. She remembers starting as an intern with Biotech Partners in high school and not knowing what a pharmaceutical company did.
“After many years of being here, I have seen and been a great part of Bayer’s contribution to the hemophilia community,” she said. “I have seen many changes over the years in this facility, which include adding many more buildings and a diverse workforce. I am a proud employee of Bayer and am excited to see what our future has in store for all.”
