Standardization News

At the height of the Islamic Golden Age, the 13th century polymath Ibn al-Nafis completed his Commentary on Anatomy in Avicenna’s Canon, a text that challenged the inherited wisdom of Greco-Roman medicine and presented groundbreaking views on pulmonary circulation. By doing so, this pioneering physician anticipated a wave of research and experimentation that would lead to the first successful blood transfusion four centuries later.

In a way, Ibn al-Nafis and his European Renaissance successors were early contributors to the field we know today as biopharmaceuticals. But the scholastic debates about ancient medicine and experiments in 16th century Oxbridge laboratories have been replaced by what is now a core part of modern medicine. From vaccines and insulin to monoclonal antibodies and gene therapies – not to mention the more than 100 million blood donations that are collected globally each year – biopharmaceuticals have become a multi-billion-dollar industry that is expanding by the day.

The Growth of Biopharmaceuticals

Biopharmaceuticals represent a diverse group of products such as vaccines, blood and blood components, and therapeutic proteins. These drugs are produced through biotechnological processes. They contrast with those that are chemically synthesized, instead deriving from living materials from humans, animals, microorganisms, or plants. Unlike the small molecules of synthesized drugs, biopharmaceuticals are considered large molecules and can often be hundreds of times larger in size.

READ MORE: 5 Essential Standards for Biopharmaceutical Manufacturing

These drugs have many applications, from treatments for rheumatoid arthritis, Crohn’s disease, and other autoimmune conditions – to cardiovascular disease and cancer treatments. Gene therapy in particular has been a key source of excitement. By replacing defective genes with healthy ones, gene therapies have the potential to treat or prevent many diseases.

“Whatever we do in the pharmaceutical industry is to treat diseases or respond to other situations, whether that means cancer or blood pressure or diabetes,” explains Ferdinando Aspesi, member of the executive committee of the committee on manufacture of pharmaceutical and biopharmaceutical products (E55). “Our body is a mix of physics and biochemistry. Physics include muscles and nerves, but there are also thousands of biochemical reactions. Whatever you do with these products is going to adjust, fix, change, or improve certain parts of this biopharmaceutical biosynthesis.”While it has many historical precursors, the modern biopharmaceutical revolution kicked off in the late 1970s and early 1980s with the biotechnological production of insulin, a hormone that had been used and researched since the 1920s.

“Modern biopharmaceuticals go back to recombinant vaccines, hormones, growth factors, cytokines, and blood factors,” explains Duncan Low, also a member of E55’s executive committee. “Historically, you could even say it goes back centuries if you think about blood transfusions. But if you keep it modern, recombinant DNA kicked off the modern biotech revolution. The initial products there were things like insulin and growth hormones. Up to that point, there were also things like antivenoms and antitoxins. The next wave was around monoclonal antibodies. The current revolution is around things like gene therapy and cell therapies.”

This current revolution is taking place on an unprecedented scale. Having grown to a $570 billion industry in 2023, many forecasts predict the continued meteoric growth of the market. As companies dedicate a sizeable part of their revenues to research and development and funding becomes more readily available, there is a growing hope that biopharmaceuticals might transform the industry as well as how we approach treating disease.

Biopharmaceuticals present unique challenges, from the uniqueness of manufacturing processes to the complexities of storing and transporting materials that are at greater risk of contamination or degradation due to temperature sensitivities and limited shelf lives. There is also the complexity of navigating the regulatory landscape as companies bring new products to market.

Biopharmaceuticals are reshaping the field of medicine.

“I’ve personally found it to be very helpful to have a dialog with regulators about what we see as the advantages and disadvantages,” Low explains. “By having standards, it facilitates the acceptance of technologies by regulators. They have confidence that this topic has been discussed through an open process, so many different stakeholders can give their feedback and have a scientific and technical dialog.”

It is against this backdrop that E55 approaches the biopharmaceutical industry. The committee addresses both chemically synthesized and biosynthetic drugs, and they aim to develop test methods, performance standards, and specifications to help ensure quality products and better health outcomes for patients. According to committee chair John Logar, this philosophy applies to any product under focus, biopharmaceutical or not.

“With a group like E55, we really focus on the manufacturing of those products,” Logar says, “and driving consensus around the best methods the best practices – providing guidance to the industry, in order to deliver effective and safe manufacturing processes for these types of products as they continue to evolve and require faster-to-market delivery. This is where E55 looks to answer that value statement by establishing practices across the spectrum so that customers and patients get the products they need regardless of where they are manufactured. ASTM has the ability to bring together these common practices and turn them into standard practices.”

From Research to Standards

The need to cut across common practices is a particularly important concern for biopharmaceuticals, given the current push for innovation and the rapid pace of development. Logar says that ASTM can serve an important function by helping to prevent companies from working in silos in ways that can generate redundancies and costs.

“What happens when working in silos is that Company A goes down a particular path with how they see a technology going, and then Company B goes down a second path with how they see it going,” he says. “The regulatory agencies are assessing them only on what they did (e.g., a singular case), which takes time, data generation, resources, and cost when doing this for every singular case.”

Creating specific standards is one major way that E55 is working to accelerate growth of biopharmaceuticals. But ASTM members have sought out other ways to be a resource for emerging developments in the industry.

FOR YOU: Manufacturing Safe Vaccines

On November 12, ASTM hosts the “Healthcare Innovation Workshop,” held in tandem with the November Committee Week in Orlando, Florida. This workshop builds on another one held in early 2023 to discuss forming a center of excellence (CoE). Looking to ASTM’s two existing CoEs focused on Additive Manufacturing (AM CoE) and Exo Technology (ET CoE), the 2023 event brainstormed questions around the challenges slowing innovation in biotech/biopharmaceuticals and how ASTM’s research-to-standards approach might contribute to the industry.

The 2024 workshop aims for a broader stakeholder group, working to identify gaps, set priorities, and enhance collaboration among industry leaders, researchers, standards developers, and policymakers.

“What we’re doing is expanding the workshop to bring a larger group of thought leaders together,” Logar explains. “We’ve been socializing it to academic institutions, to regulators, to individual companies. And not just in biotechnology, because we want this collaboration to be cross-industry now that we’re moving further into the workshop phase. That way, when we go to formulate some focused teams, we have the right stakeholders in the right places to drive innovation.”

Through efforts such as this workshop, E55 members believe they can help promote safer and more effective developments while encouraging and accelerating innovation.

“ASTM can communicate the importance of better work among these areas,” says Aspesi. “There is a way to reach people that have understanding and knowledge that can be used to arrive at consensus standards. You can share your knowledge, you can learn from others, and you can build innovative solutions.” ■

JP Ervin is content editor for Standardization News.