Immunosuppressive Humira, shown above using VR molecular visualization software Nanome, is considered a biopharmaceutical

“I think the biggest innovations of the 21st century will be at the intersection of biology and technology. A new era is beginning.” — Steve Jobs

In spite of its relative nascence, the biopharma industry, whose roots might begin with the biotech start-ups of Boston and the Bay Area in the mid-1980s, consistently creates top-selling drugs. Medical biotechnology had become a $150 billion-a-year business by the end of 2018.

Among the most recognized bio-pharmaceutical companies in the world are Roche, Amgen, Celgene Corp., Gilead Sciences, Biogen Inc., Novo Nordisk, Merck, and Baxter BioScience. Engineers, microbiologists, process scientists and analysts work in hubs such as San Diego, the Bay Area, and Boston.

What is the Biopharmaceutical Industry?

Biopharmaceutical is an umbrella term for medical drugs that are created with biotechnology.

Beer, wine, wash detergent, and everything plastic is all considered biotechnology product. Humans have used biotech for millennia to breed animals and improve crops.

In finance, biotech entails researching, developing, and producing mostly products or medical and agricultural purposes.

Biopharmaceuticals are manufactured in or extracted or semi-synthesized from biological sources, such as cells and living organisms. Traditional pharmaceuticals, on the other hand, are created instead through chemical synthesis. The biopharmaceutical industry also works on problems in bio-defense, and has benefited from new breakthroughs in DNA research.

Biopharmaceuticals treat a wide-ranging list of ailments and include vaccines, blood components, allergenics, somatic cells, gene therapy, tissues, recombinant therapeutic proteins, and living cells.

These proteins, antibodies, nucleic acids (DNA, RNA or antisense oligonucleotides) are leveraged for therapeutic or in vivo diagnostic treatments. They’re produced with the help of a native (non-engineered) biological source.

Genentech’s recombinant human insulin (rHI, trade name Humulin) was the first substance approved for therapeutic use. Eli Lily started marketing it in 1982. Among the most popular biopharma products include AbbVie’s Humira for arthritis, psoriasis, and Crohn’s disease, and more; Roche’s Rituxan to slow the growth of tumors in several types of cancer; and Amgen/Pfizer’s Enbrel for autoimmune diseases.

The Nanome Booth at PepTalk, a science conference with an emphasis on biologics and biopharma.

How are Biopharmaceuticals Made and Why?

Biopharmaceutical products are mostly derived through experimentation on life forms. Pharmaceutical companies are increasing their development efforts in the biopharmaceutical space while minimizing research on small molecule drugs, which are not generally viewed as biopharmaceuticals. Some companies are spending 40% or more of their R&D budget on biopharma.

New innovation in the biopharmaceutical industry encompasses work on things such as biosimilars, which is a biologic medical product modeled after another pre-existing product, yet manufactured by a different company.The biopharmaceutical industry has also driven research in personalized medicine and created opportunities in emerging markets.

A major goal for the industry is further innovation and increased productivity. Swift innovation means swift discovery, which would drive down costs, and improve productivity.

Therefore, data analytics plays a big role in biopharma, since it underpins our fundamental scientific understanding of the biological process, from genomic analysis to protein characterization. Data analytics can also optimize the manufacturing process, including along the supply chain.

Exploring the Biopharma Market

Biopharmaceutical companies will need to distinguish themselves in the market through low manufacturing costs. For that purpose, billions of dollars are being allocated to research on bioprocessing innovations. There are, in addition, a growing number of global biopharma facilities worldwide. This will surely foster competition in the biopharmaceutical industry, and lead potentially to more biological products and new categories.

The key trends in this industry are being driven by the need for a more efficient biopharmaceutical design process, greater quality, and cost reductions in manufacturing processes. To remain competitive, especially as biosimilars and bio-betters evolve, improved ways of evaluating new technologies are needed that cut down on time to market and make more efficient and effective the overall testing process.

Some biopharmaceutical companies depend on innovation by the supplier to advance production processes for current biologics, biosimilars products, and for the production of biologics in emerging markets to use flexible processes.

With the biopharmaceutical industry experiencing growth in recent years, complex new therapies have been discovered. Advances in areas like recombinant DNA and hybridoma technology, as well as gene and cell therapies, has propelled biopharmaceuticals forward.

Biopharmaceuticals are also changing the way in which it monitors innovation by implementing continuous monitoring systems. Some are exploring new technologies like blockchain, so that results regarding product quality happen in real time.

A 3D representation of the biopharmaceutical and Immunosuppressive Humira, which was produced using biotechnology.

Why Biopharma is Growing

Biopharmaceuticals are expected to become increasingly prominent in product use and sales, and biotherapeutics have been long administered to save lives and make us comfortable in our last days — in fact, more often than chemically-composed pharmaceuticals.

The Challenges Facing Biopharmaceuticals

Biotherapeutics are not easy to manufacture. The specialized and expensive processing and purification techniques are sensitive to their environment, and variations in the production process can considerably affect a product’s efficacy. (When executed correctly, biopharmaceuticals offer high efficacy and even fewer side effects over conventional pharmaceuticals.)

Since biopharmaceuticals are sensitive to their environment, reproducing the large molecules used in biopharmaceutical research calls for “manufacturing capabilities of a previously unknown sophistication,” according to a report by Mckinsey.

The report continues: “…[A] molecule of aspirin consists of 21 atoms. A biopharmaceutical molecule might contain anything from 2,000 to 25,000 atoms… The ‘machines’ that produce recombinant therapeutics are genetically modified living cells that must be frozen for storage, thawed without damage, and made to thrive in the unusual environment of a reaction vessel. The molecules must then be separated from the cells that made them and the media in which they were produced, all without destroying their complex, fragile structures.”

That’s not easy. What this means is a high cost to produce biopharmaceuticals at an industrial scale. Biotech facilities can cost between $200 million to $500 million to build and are costly to run. Small-molecule facilities can cost between $30 million to $100 million.

The Future of Biopharma

Despite these challenges, the biopharmaceutical industry is a major part of the world of medicine, and its discoveries help to treat cancer and diseases of the immune system. Hospitals and pharmacies are filled with drugs developed via biopharmaceutical processes.

The variety of advances across the biological sciences that come through a clinical trial, will include bispecific antibodies, cell therapies, gene therapies, and evolution towards precision medicine.

McKinsey research opined that “Biopharmaceuticals are among the most sophisticated and elegant achievements of modern science. “

There is always progress in the field of biopharmaceuticals as “existing treatment archetypes are evolving and becoming more sophisticated all the time, and continuing research is yielding entirely new types of products,” writes Mckinsey, adding: Radically new concepts are making it to the market, such as the cell therapy Provenge, which is used to treat cancer, and, somewhat further out, gene therapies, which offer even more amazing promises of regenerative medicine or disease remission.”

Biopharmaceuticals generate hundreds of billions in revenue and represent approximately 20 percent of the global industry. The current annual growth of the biopharmaceutical industry is over 8 percent. That’s twice the amount of the conventional pharmaceutical industry.

Efficacy, safety, and an innovative nature lead to high prices for medicines created through the use of biotechnology. And so, the biopharmaceutical industry must be able to swiftly and consistently produce small batches of personalized medicines in order to deliver cell therapies. It must also produce low-cost insulin and vaccines to fight diseases that afflict low and middle-income parts of the world.

New technology is offering new insights into the world of biopharmaceuticals, such as Nanome’s molecular visualization software.

Biopharma Future: New Innovation, New Software

Pharmaceutical products take a long time to research, develop and bring to market. While part of that is due to waiting on Food and Drug Administration (FDA) approval in the U.S., new technologies such as virtual reality could help the industry hasten the time it takes to bring a biopharmaceutical product to market and minimize its overhead on the path to designing novel biopharmaceuticals.

Nanome’s virtual reality-based molecular visualization tool, for instance, is being used by top labs on multiple continents towards developing the biopharmaceutical medicines of the future.

Or, if you want to see scientists checking out molecules (including biopharmaceuticals) for the first time in virtual reality, check out the video below: