On World Standards Day, Celebrating a Century of Biological Standards for Medicine Safety

On a crisp October morning, the frantic hum of the Medicines and Healthcare products Regulatory Agency (MHRA) science campus mirrors the excitement found in a bustling laboratory. Here, scientists tread the fine line between life and the unknown, ensuring that every vial of medicine, every vaccine, and every diagnostic test meets a singular, monumental benchmark: the biological standard. As the world recognizes World Standards Day on 14 October, the MHRA commemorates a century since setting the first biological standard, a milestone that has not only protected patients in the UK but also established a global standard for safety and efficacy in medicine.

What are Biological Standards?

Biological standards serve as an essential safeguard in medicine production, particularly for those therapies derived from living organisms. Unlike chemical compounds that can be quantitatively measured, biological substances require a different approach. To ensure that medicines perform reliably, scientists employ bioassays—special biological tests that can yield varying results due to the nature of living organisms. Without biological standards, inconsistencies in dosing could lead to dangerous consequences, from ineffective treatments to overdose cases that risk patient safety.

• Biological standards create a common language: They enable doctors, scientists, and regulators to discuss a medicine’s potency or effectiveness uniformly.
• Consistency is key: Standards prevent variations across different production batches, ensuring that patients receive reliably effective treatment.
• Global collaboration: By standardizing biological measures, countries can unite in healthcare efforts, from manufacturing to patient administration.

Paul Bowyer, Deputy Director of Standards Lifecycle at the MHRA, elaborates, “The biological standards developed, produced, curated and supplied by the MHRA not only support the safe development, testing and use of a wide range of medicines, vaccines, and diagnostic tests, but they also pave the way for scientific discoveries to be compared, repeated, and built upon.” As a trusted supplier of over 95 percent of the World Health Organization’s (WHO) biological standards, the MHRA plays a pivotal role in global health.

A Century of Setting Standards

The journey towards biological standardization began with the fight against diphtheria in the late 19th and early 20th centuries. At a time when diphtheria claimed countless young lives, treatments varied dramatically in strength, leading to inconsistent outcomes. What was deemed an effective dose by one physician could be perilous for another. This realization catalyzed scientists to develop a standardized formula that paved the way for consistent and life-saving dosages. In 1925, British scientists created the first international biological standard for insulin, ensuring that diabetes patients could rely on a uniform dosage regardless of the manufacturer.

As we glance back at this century of innovation, the data is compelling: in the last year alone, the MHRA supplied over 110,000 vials to 1,500 organizations across 81 countries—from hospitals to product manufacturers. This extensive network exemplifies both the regional and global impact of biological standards.

Modern Medicine and Future Standards

Fast forward to today, and the spectrum of medicines continues to expand with cutting-edge therapies like monoclonal antibodies, cell therapy, and gene editing. The MHRA now maintains an expansive catalog of over 450 WHO biological standards, integral for the development, testing, and monitoring of these sophisticated medical solutions. The future also shines with promise as the MHRA prepares to innovate in fields such as microbiome research, where understanding the trillions of microorganisms residing within us could unveil new therapeutic avenues.

Dr. Naomi Richards, a prominent biologist working on microbiome studies, asserts, “As we delve deeper into the microbiome, having biological standards in place ensures we can assess the efficacy of our findings without ambiguity. It opens doors for accelerated research while maintaining patient safety.” The need for rigorous standards has become more imperative than ever, especially as emerging therapies race to meet global health needs.

Trust in Treatments

The overarching goal of the MHRA and its century-long endeavor in setting biological standards is to instill trust—trust that when patients receive a medicine, it will perform equivalently, regardless of its origin. Without these standards, healthcare becomes a gamble. Variability in drug performance threatens not only individual patient outcomes but also broader public health initiatives. In an era marked by rapid technological advances and global challenges, the MHRA’s commitment to biological standards offers stability in a volatile landscape.

The centennial celebration of biological standards is not merely a recognition of past achievements; it is a clarion call for an ongoing commitment to excellence in medical safety. As scientists continue to forge new paths in therapies, the MHRA remains steadfast, ensuring that the integrity of medicine is upheld, that its efficacy is never questioned, and that patients worldwide can feel secure in their treatments.

At this pivotal moment in the history of medicine, the scientists at the MHRA are tirelessly working to uphold a legacy of safety and efficacy that spans a century—a legacy that promises to innovate widely while serving the vital function of protecting lives.

Source: www.gov.uk