Biologics are transforming treatments for cancer, genetic disorders, and autoimmune diseases, however manufacturing them at scale remains a challenge. Small variations between batches create ongoing quality control challenges, pushing experts to improve efficiency without compromising standards.

Ilkin Mahmudov, Quality Operations Director at Bora Pharmaceuticals discusses how today’s drug manufacturers are filling the growing need for biologics without rushing complex processes in development or quality control.

Contract Pharma: How have quality control procedures evolved alongside the complexity of biologic production?

Ilkin Mahmudov: The short answer is that quality control (QC) has had to keep pace with biology itself…and biology doesn’t stand still. When you’re manufacturing small molecules, a lot of your quality assurance happens at the end by testing the finished product. Biologics don’t work that way. These are living systems, and if something goes wrong upstream, you can’t necessarily catch it at the end. So, the industry has shifted to rely more heavily on real-time monitoring to maintain control throughout the process rather than relying only on final product testing. This puts an emphasis on process characterization, critical quality attributes, rapid microbiological methods, viral safety controls, environmental monitoring, and more throughout the entire manufacturing chain.

Contract Pharma: What are new considerations in sterility, contamination, and product yield?

Ilkin Mahmudov: When working with living molecules, contamination risks aren’t limited to the traditional threats posed by bacteria and fungi. Now, cross-contamination, viruses, and particulates (among other sources) pose a threat to biologic sterility. To combat the increased number of threats, the industry is rethinking all contamination control strategies, including facility design, automation, and closed processing. Ultimately, these considerations all aim toward the same goal: reducing the need for human intervention on the line to cut down on possible contaminant exposure.

As for product yield, the challenge is striking a balance. Producing more only matters if those products are fit for market, challenging the industry to increase output with the same quality standards. By integrating new technology and safety guidelines, the industry can continue to scale biologics production, providing better medicines to patients who need them. 

Contract Pharma: What are upcoming challenges and opportunities to balance speed and quality in life-saving drug production?

Ilkin Mahmudov: Biologics manufacturing is still in its relative infancy, but that shouldn’t matter to the patients who need fast access to life-saving medicines. The challenge is balancing this need for speed with the processes required to produce safe biologic medicines. Fortunately, the industry has many tools at its disposal. Advanced technologies, such as predictive analytics and automation, are able to shorten timelines without sacrificing quality.Part of the reason these opportunities are in front of us is the FDA’s Advanced Manufacturing Technologies (AMT) program, which enables the industry to innovate. Slow to scale, prone to variability, and supply chain disruptions are some of the most common challenges pharma manufacturers face. Only after addressing these can the industry improve the quality and consistency of its products and enable faster delivery of critical drugs to patients.

Ilkin is a Quality professional with extensive knowledge of cGMP, GLP, and Quality Management Systems. Ilkin specializes in Quality Systems with experience in drug, medical device, and specialty ingredients manufacturing. Ilkin is the site leader for all Quality Assurance, Quality Control, Microbiology, and R&D activities.