I had never even heard of Malvern, Pennsylvania – but I had a rather enlightening experience when I visited for the first time. Janssen is a pharmaceutical company that has developed several biologic medications used to treat rheumatoid arthritis – including Remicade (infliximab), Simponi (golimumab), and Simponi Aria – and one of their research, development, and manufacturing facilities is located in Malvern. I was recently given the opportunity to take their BioExperience Tour, a tour of their manufacturing and supply chains that highlights the people and processes behind the development of biologic therapies.
Before I share my own experience, I want to first draw your attention to my disclaimer at the bottom. Janssen did pay my travel expenses and give me permission to share what I learned on the tour, but everything in this article is my own opinion. I’m not a spokesperson for any particular pharmaceutical company or brand of medication – I’m simply a patient living with rheumatoid arthritis. While the tour had previously only been given to healthcare professionals and managed care groups, I was among the first patient advocates to have the opportunity to attend, and I thought it was an experience that might interest other patients too.
The first step in developing a new biologic medication is clinical trial compound production – or the biologic monoclonal antibody (mAb) process. If that sounds like a confusing and complicated mouthful, that’s because it is! During this process, scientists study and analyze more than one billion potential molecular sequences to try to find one that can be advanced to clinical development and manufacturing. Like snowflakes, no two sequences are the same. It’s also important to keep in mind that these molecular sequences are extremely complex. Here’s an illustrative analogy: an ordinary medication, like aspirin that you might get in pill form, has a molecular structure like a log cabin. In comparison, a biologic medication, which would likely need to be administered via injection or infusion, has a molecular structure as complicated as the Empire State Building! Biologic medications are also made out of living entities. From a 1ml vial with ten million cells to growing huge quantities of cells in bioreactors, cell cultures are grown in the lab to produce mAb and must be continually fed – so the lab operates 24 hours a day, 365 days a year. The mAb must then be concentrated and finally purified to remove impurities and inactivate and remove viruses.
Once the molecular structure of a biologic medication has been identified and tested, the manufacturing process can begin. In manufacturing, bulk batches are made from cell cultures, ensured of purity, and prepared and packaged for use. However, because of the potential for contaminating the medication and affecting patient safety, we were not able to actually tour the manufacturing facility. Instead, we were given a virtual tour and a gowning demonstration.
Gowning is a multi-step procedure performed by every employee who works in the manufacturing facility. Each employee has special shoes worn only in the manufacturing facility. Over their scrubs goes a jumpsuit that zips up the neck. They wear rubber gloves, booties over their special shoes, eye goggles, and a net over their hair and facial hair. Then they put on another pair of booties that go up to the knee, more rubber gloves, another head covering, and a face mask. And while it may seem like the employee would be sufficiently covered at this point, for the inner core of the manufacturing facility, there’s yet another lab coat, sleeve coverings, and another pair of gloves. Each part of the procedure is performed in a separate airlock and includes disinfecting the hands between steps, and each of the layers is pre-packaged and pre-sterilized. This procedure is carefully followed to protect the medication from contamination and must be repeated every time an employee enters the facility. This means that between lunch, breaks, and trips to the restroom, the average employee gowns about five or six times per shift.
The process of packaging and device design is also a lot more complicated than it might seem at first glance. For example, many biologic medications need to be refrigerated, and the molecules need to remain stable once they have been transferred from the manufacturer to the pharmacist and, ultimately, to the patient. This means that tests need to be performed in order to make sure that the molecule is stable at the desired temperature, but also in case the package gets left out of the refrigerator or if there’s a delay in shipping. When it comes to medications that are self-injected by patients, scientists think about ways to make this process easier by considering things like how easy the syringe is to hold and administer.
One of my favorite things about the tour as a whole was the opportunity to meet the scientists who worked at various steps of the process. There was a lot of information to be absorbed, and a lot of what they told me honestly went over my head. Still, I could see and feel the scientists’ enthusiasm. They each had a passion for the part of the project they were working on. They were eager and committed to finding working treatments for individuals living with chronic illnesses – maybe even a cure! I’m very pleased to know that there are such devoted individuals working to give patients like me a better life.
I am extremely grateful that biologic medications exist, as they have vastly improved my quality of life with rheumatoid arthritis. However, I must admit that I have personally experienced a lot of frustration due to high costs and limited options. I’m glad that I had the opportunity to take the BioExperience Tour, as it helped to illuminate the complexities involved in discovering, developing, manufacturing, and delivering biologic medications. I understand now that part of the reason these medications are so expensive is that an immense amount of work goes into discovering the proper sequence, growing the live cells, figuring out how to remove all the impurities, following procedures to make sure the product isn’t contaminated, and safety testing the product for patient use. I found the experience to be very eye opening – and I thought other patients might as well!
Janssen paid my travel expenses. All opinions expressed in this article are my own.