World Cancer Day which has just gone by is a reminder that closing the cancer care gap is not only about new discoveries—it is also about whether proven cancer medicines reach patients reliably, affordably, and on time. In oncology, manufacturing is not a backend function—it is a frontline determinant of treatment continuity.
Cancer therapy is uniquely sensitive to supply stability because many regimens follow strict schedules. A missed or delayed cycle is not a small inconvenience; it can impact outcomes, increase patient anxiety, and add pressure on clinical services. At the same time, oncology products–especially sterile injectables are among the most complex medicines to manufacture. They require stringent sterility assurance, high-potency handling, robust containment, and consistent batch-to-batch performance. This is where “new-generation manufacturing” becomes a real access lever: it is the shift from reactive quality checks to systems that deliver predictable quality at scale, while improving efficiency so costs can reduce without compromising patient safety.
A major shift is moving from “testing quality at the end” to “building quality into the process.” Modern sterile manufacturing increasingly focuses on tighter contamination control strategies, minimising open handling, and reducing human interventions in critical aseptic zones—because people remain the biggest contamination risk in aseptic processing. When contamination risks reduce, there are fewer batch rejections, fewer recalls, and fewer sudden shortages—meaning hospitals can plan therapy cycles with greater certainty.
Another high-impact area is lyophilisation (freeze-drying), widely used for many oncology injectables to improve stability and shelf life. The innovation is not just owning the equipment – it is controlling the science and the process: Cycle development, moisture control, container-closure integrity, and reliable reconstitution. Better-controlled lyophilised products tolerate real-world storage and distribution more effectively, especially where cold-chain or hospital pharmacy infrastructure is limited. Higher stability also reduces wastage and stock write-offs, which supports both availability and affordability.
New-generation manufacturing also relies far more on data-driven control and faster decision-making. Historically, quality was proven late in the process, often creating long testing and investigation cycles that delayed batch release. Today, many facilities are building stronger process understanding and real-time monitoring using Process Analytical Technology (PAT) principles—so deviations are detected earlier, root causes are identified faster, and batches can be released with confidence.
For suitable products (particularly many oral therapies and certain intermediates), continuous manufacturing is also gaining momentum. While sterile injectables are often still batch-based, continuous approaches can improve consistency, reduce scale-up friction, and support agile capacity management. Agility reduces the risk of gaps.
AI is also starting to play a practical role in oncology manufacturing—not as a “future concept,” but as an operational accelerator. By applying AI and advanced analytics to equipment data, environmental monitoring trends, and batch records, manufacturers can predict process drift early, reduce unplanned downtime through predictive maintenance, and flag atypical patterns that may lead to deviations. This supports faster investigations, more consistent sterility assurance, and improved right-first-time performance—ultimately translating into steadier supply and fewer disruption-led shortages for hospitals and patients.
Alongside this, the next era of cancer treatment is being shaped by NDDS (Novel Drug Delivery Systems) and biological products, including complex injectables and biologics-based therapies. NDDS—such as liposomal formulations, long-acting depots, nanoparticle-based delivery, and targeted delivery platforms—aim to improve how a drug reaches the tumour, reduce systemic toxicity, and enhance patient tolerability. Biological products, while clinically transformative, raise the manufacturing bar significantly: they demand tighter control of process variability, advanced analytics for product characterisation, and robust cold-chain readiness.
All of this feed into affordability, but not in a simplistic “cost cutting” way. In oncology, affordability improves when variability reduces. Manufacturing modernisation drives that through measurable mechanisms: Higher right-first-time yields (less scrap and rework), lower deviation rates (less downtime), shorter batch release cycles (lower inventory and working-capital load), stronger stability performance (less distribution loss), and more robust digital quality systems (fewer compliance disruptions). When failures and delays decrease, supply becomes steadier and the overall cost-to-serve comes down – supporting more sustainable pricing and broader availability.
Finally, access is increasingly linked to trust and traceability. As cancer medicines scale across geographies, supply chains must defend against counterfeits, diversion, and data integrity risks. Strong track-and-trace systems, serialisation, and end-to-end quality documentation are becoming part of access infrastructure, not optional extras.
The most effective World Cancer Day message is operational and actionable: Innovation that reduces the time, cost, and uncertainty between a factory batch and a patient dose. New-generation manufacturing does exactly that—strengthening sterility assurance, improving stability, accelerating release, and building resilient supply.
This article is authored by Mohan Jain, director, Naprod Life Sciences Pvt. Ltd.
