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.
We sat down with Alexei Voloshin, an application engineering manager for 3M’s Separation and Purification Sciences Division, to learn more about biologics. He explains why the manufacturing process is so important (hint: it’s got everything to do with purity) and how 3M Science is helping pharmaceutical companies bring more of these life-saving and life-changing medications to people around the world.
“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.”
Voloshin: There is a long history of people searching for and using medicinal substances to try to treat conditions – arsenic was once used for medical purposes. As medical science advanced so did the expectations of efficacy and safety of the therapeutic technology used to treat medical conditions. Current traditional treatments like acetaminophen and ibuprofen are examples of chemical substances used to treat simple conditions such as muscle pain. They are not able to precisely discriminate in how they affect the body – ibuprofen can affect your stomach lining and other tissues. Chemotherapy, another traditional treatment, may kill the cancer, but it can also damage the rest of your body. There is also a limit on what you can expect with traditional chemically derived drugs.
Biopharmaceutical technology brings the next qualitative level of potency, selectivity and safety to medical treatments by utilising more advanced molecules such as proteins, nucleic acids, lipids, viruses and cells. This unique combination of qualities enable this class of drugs to enable effective treatments of serious conditions such as cancer, arthritis and ulcerative colitis. With treatments for diseases such as diabetes and Alzheimer’s being tested in the clinic today, biopharmaceutical technology has only begun to fundamentally change the expectations of the quality of life of the society at large. In fact, current state-of-the-art COVID-19 vaccines are products of modern biotechnology. This approach helped enable unprecedented speed of development for vaccines.
Voloshin: First, biologics are injected, so they have to be very pure. 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. So whether it’s a synthetic or biologic treatment that’s injected, it needs to have a very high level of purity.
Biologics are also relatively fragile compared to synthetic substances. You might reduce or kill their efficacy if you manipulate them – 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 complex. Each product has a specific process for manufacturing – there are similar strategies for manufacturing, but each one is unique.
Voloshin: 3M has a two-pronged approach: One, advancing existing manufacturing processes and two, leading the innovation in new processes to accelerate biopharmaceutical development and manufacturing.
Many pharmaceutical companies may have an existing biologic product and process and are looking for ways to scale up production very quickly. 3M depth filtration and membranes can help them when demand rises for an existing process, using a more traditional approach to separation. For biopharmaceuticals to be readily available, they need to be able to rely on a well-planned, sophisticated global supply chain.
New classes of biopharmaceutical products require new production processes and 3M can help with innovative manufacturing solutions. Much of the separation of impurities from the drug involves materials science. 3M leverages our advanced technology platforms and develops new disruptive solutions. We enable high-performance separation and help simplify processes. We use non-woven materials to separate soluble and insoluble materials at the same time and with even better performance compared to traditional approaches. The non-woven material allows us to combine multiple parts of the process into one while giving higher purity and higher yield. You can make more product.
"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."
Voloshin: Our customers in pharmaceuticals have a long-term view. When they are ready to commercialise a product, they look at the technology available. They work with suppliers like 3M early on. We work with our customers through the lifetime of the product. Throughout the journey, we work closely together starting with product development. We understand both short- and long-term goals and expectations– the telescope and microscope approach. We are constantly looking at developing new applications for new or existing needs.
There are a number of things that are rewarding about this work – knowing that what we do every day changes how people perceive their quality of life and the faster we can accelerate the development of these products, the faster they can help people. We are helping society move quickly toward democratising the treatments so they can be more widely available around the world. Being able to use 3M technology platforms allows us to address new frontiers and bring value to society. 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 – from Minnesota to New Delhi.