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Female patient getting a vaccine from a nurse

When you hear the term pharmaceuticals, you might think of pills with complex chemical formulas — the pain relievers or high blood pressure medication that line the shelves of many medicine cabinets. Medications with chemical ingredients are still common, but more and more pharmaceuticals now come from sugar, proteins or living cells. These biopharmaceuticals, also known as biologics, can be prescribed for some illnesses with no effective treatments — and often with fewer side effects than traditional chemical-based medications. Learn how Solventum is helping to make these treatments more readily available.

We sat down with two experts from our Biopharmaceutical Purification team: Jonathan Hester, Ph.D., a research scientist, and Alexei Voloshin, an application engineer, to learn more about biopharmaceuticals, including protein-based therapeutics and vaccines. They explain why the manufacturing process is so important (hint: it’s got everything to do with purity) and how we help pharmaceutical companies move healthcare forward with game-changing new medical treatments.

Biologics explained

Humankind has a long history of searching for medicinal options to treat conditions. Even arsenic was once used for medical purposes. But as medical science advanced, so did expectations for the effectiveness and safety of these treatments. 

Current traditional treatments like acetaminophen and ibuprofen are examples of chemical-based medications used to treat conditions like muscle pain. They are typically effective, but often have side effects. “They are not able to precisely discriminate in how they affect the body — ibuprofen can affect your stomach lining and other tissues,” says Alexei. Chemotherapy, another traditional treatment, may kill the cancer, but it can also damage the rest of your body, he adds. 

Biopharmaceutical technology uses more advanced molecules such as proteins, nucleic acids and cells. “The unique combination of potency, selectivity and safety enable this class of drugs to provide effective treatments of serious conditions such as cancer, arthritis and ulcerative colitis,” says Alexei. “Biopharmaceutical technology has only begun to fundamentally change the expectations of the quality of life of the society at large.” 

Biopharmaceuticals are on the cutting edge of treating life-threatening and life-changing conditions with maximum efficacy and safety. And their story is just beginning.

Alexei Voloshin

 

One example you’re likely familiar with are current state-of-the-art COVID-19 vaccines, which are products of modern biotechnology. This approach helped enable the speed of development for these vaccines.

The promise of protein-based therapeutics and vaccines

For many years, vaccines have been developed using inactivated viruses. These weakened viruses, when given to a patient, stimulate an immune response in the body to protect against future infections from that virus. This approach is still effectively used for influenza, chickenpox, measles and mumps, but it requires scientists to grow viruses in a lab, which can take months.

In recent years, researchers have developed vaccines using purified proteins, which may have been purified using Solventum technology, to prevent the virus from attaching to and entering into human cells. These vaccines can be developed more quickly without the inherent risks associated with the use of a live virus. Protein-based vaccines include HPV, shingles hepatitis B and COVID-19

These protein-based biologics are also used to treat disease. “Some of the most promising therapeutics right now are protein-based drugs,” says Jonathan. “Pharmaceutical companies make protein drugs by genetically engineering a cell — usually a mammalian cell — to make the protein.”

He explains that engineered cells are grown in a culture for days or a couple weeks. After that time, they will have a fluid that contains the protein drug the cells have made, but it also contains the cells, debris from broken cells and all sorts of other proteins that have been produced by the cells.

A peek into the process: How protein-based biologics are manufactured

Once the biopharmaceutical manufacturer harvests the fluid, they have to isolate the drug protein from cell fragments, from other proteins the cells have made and also from DNA and other contaminants. It’s typically a 15- to 20-step process to isolate the drug protein in a pure form.

“Biologics are injected, so they have to be very pure,” says Alexei. When a pill or liquid is ingested, the digestive system helps clear contaminants. With pharmaceuticals that go into the bloodstream, that barrier is no longer there.

Biologics are also relatively fragile compared to synthetic substances. “You might reduce or kill their efficacy if you manipulate them,” adds Alexei. “You can’t heat them, treat them with a high pH or subject them to sheer stress. So, the process to purify these drugs without damaging them is more complex compared to synthetic drugs.” 

How we’re solving to meet manufacturing challenges 

Solventum helps manufacturers by using smart materials to reduce the number of steps and make purification steps that are more reliable. Our work can help pharmaceutical companies spend less time doing the purification process development work, which can ultimately help vaccines get to patients faster. 

“Each product has a specific process for manufacturing,” says Jonathan. “Our objective is to condense the process for our customers — to simplify and reduce the number of steps and help them to get more quickly through clinical trials and, ultimately, to have more economical and productive manufacturing processes for the successful drugs.”

When we visit our customers, we get a sense for how our purification products are a part of something that helps improve and save lives.

Jonathan Hester

 

One of our technologies, the 3M™ Emphaze™ AEX Hybrid Purifier, was developed to replace a simple filter that takes out chunks of cells and cell debris. When development work on this began, scientists hypothesized it could remove soluble contaminants, too, and make one device that does two things at once. Two process steps are now one with this purifier. The base technology has now been extended to a second product, 3M™ Harvest RC, that operates at the very beginning of the purification process. It removes the same soluble contaminants while also gently removing whole cells by sticking to them, instead of removing them in the more typical way by simply forcing the fluid through pores smaller than the cells. Sticking to them gently reduces the pressure required and minimizes cell breakage so more of their internal contaminants stay inside and are removed with the whole cells.

How the purification technology works

Nonwoven materials — in simple terms, a mat of fibers — are key to a few Solventum purification technologies. They are modified for purifying by grafting positively charged polymers to a nonwoven to make a material that acts like a filter but also binds negatively charged particles and molecules. The proteins you want to keep are usually positively charged and most contaminants are negatively charged. 

When the protein product goes through the filter, the negatively charged contaminants — cells, cell chunks and dissolved contaminants like DNA — stick to it. This helps generate a purer product at the front end and enables more consistent fluid quality throughout the entire process.

Removing DNA earlier in the purification process also makes a subsequent separation process much more effective. For many customers, this further condenses downstream steps and also increases yield of the drug product. 

Rewarding work: Designing solutions that can help improve health for everyone

Reducing process steps and increasing yields can help make potentially lifesaving treatments more available. Plus, it can reduce costs. 

Jonathan notes that COVID-19 gave more people an insight into what people with illness are going through — waiting and hoping for a cure or a treatment. “Knowing we are working on speeding the development of these treatments motivates everyone in our group,” he says. “Our biopharmaceutical customers have really difficult problems to solve, and our people-centered science can change lives for the better.”

Through our technology, we can help make the difference from a drug being an academic wonder only, to being able to produce medicine that advances the human condition around the world.

Alexei Voloshin