“ADCs often require a specialist high-mix, low-volume packaging environment with the agility to support small-batch production, frequent changeovers, multiple SKUs, and evolving labeling and packaging configurations, supported by robust documentation controls and a flexible approach to validation,” says Jeff Benedict, CCO at Sharp.
That challenge is becoming increasingly important as the ADC market grows. Antibody-drug conjugates (ADCs) often launch for relatively small, indication-specific patient populations, but the picture can change quickly. New indications, new markets, and new dosing configurations can all follow as additional approvals come through.
For commercial packaging teams, that growth creates a moving target. The same product may require multiple SKU changes within just a few years of launch, with each change bringing new validation work, label updates, and production changeovers, all while maintaining compliance and continuity of supply.
This is where ADC packaging becomes particularly complex. The science may get much of the attention, but behind every expanding ADC program is a packaging operation that needs to be flexible enough to keep pace.
Balancing Containment and Agility
ADCs pair a targeted antibody with a cytotoxic payload, which means secondary packaging has to do two jobs simultaneously: protect a biologic from temperature, humidity, and light degradation, while maintaining high-containment handling for a potent small molecule. Jeff describes secondary packaging as “a critical component of the product’s overall control strategy”. Not a downstream step, but part of how the product stays safe and compliant from validation through distribution.
Jeff sees this as a key reason companies are turning to specialist CDMOs and CPOs. These partners have already invested in the containment systems, operator safety protocols and environmental controls that ADCs require, giving them the flexibility to manage frequent changeovers and multiple SKUs without compromising validation or compliance.
Packaging for Changing Formats
Most ADCs today ship as lyophilized powder in sterile vials with light-protective cartons. That’s likely to change. Pre-filled syringes, ready-to-use presentations, and eventual integration with autoinjector or pen platforms are all in view as the category matures. Shifts that could meaningfully reduce burden on both patients and healthcare providers. Packaging teams have a specific role to play here: aligning early with a sponsor’s drug-device combination strategy so that functional and packaging compatibility holds up across each stage of that transition, rather than becoming a bottleneck at the next format change.
Sustainability Outside the Box
For ADCs, the usual sustainability playbook doesn’t quite apply. In many packaging environments, reducing environmental impact starts with using less material. But with ADCs, there’s often less room to simplify: high-containment handling and strict product protection requirements put clear limits on what can be removed or redesigned.
That shifts the focus elsewhere. Jeff points to opportunities within the facilities themselves. High-containment operations can be energy-intensive, making improvements in HVAC efficiency, airflow management, and real-time digital monitoring particularly important. Some of these energy demands may be inherent to the process and containment strategy, but there is still plenty of scope to manage them more efficiently.
The Complexity of Going Global
Global launches add another layer of complexity. Approvals in the US, EU, and other markets rarely arrive at the same time, leaving sponsors to manage different timelines, batch sizes, and packaging requirements for the same product.
That’s changing what they need from a packaging partner. Increasingly, sponsors are looking for operations that can handle small-batch validation and larger-scale commercial production within the same setup, and adapt as launch requirements evolve.
For Sharp, that means getting involved during development rather than waiting for the commercial handoff. FTZ operations and EU QP release can also help keep batch certification moving alongside packaging, rather than adding another sequential step to the launch process.
The fundamentals of ADC packaging haven’t changed: protect a sensitive, potent product and get it to patients safely. What has changed is the pace, scale, and variability sponsors need to plan for. Increasingly, the ability to manage that complexity is becoming part of the packaging-partner decision itself.
Sharp is a secondary packaging and commercial launch partner supporting cold chain, cartoning, kitting, and serialization for injectable and high-potency products, including ADCs.
For information on planning and executing packaging activities for a successful commercial launch, download this whitepaper.
The ADC market
The first ADC was approved in 2000, combining a potent cytotoxic payload with the targeting precision of a monoclonal antibody. More than two decades (and plenty of technical and safety challenges) later, the field is still relatively early in its evolution. But it has also become one of the most promising and fastest-growing areas in oncology, and the numbers reflect this.
As of May 2026, around 23 ADC products had been approved globally, with many more progressing through late-stage development. According to GlobalData, 93 Phase III trials were initiated in 2025, up from 67 in 2024 and 31 in 2023. The market, valued at around $20 billion last year, is expected to reach $60 billion by 2030. And with 412 ADC programs currently at various stages of clinical development, the pipeline suggests there is much more to come.
But growth is only part of the story. The ADC landscape is also becoming more diverse. New targets, novel payload strategies, and combination therapies are expanding the possibilities for these treatments, with early research even exploring their potential beyond oncology in areas such as autoimmune disease, viral infections, and neurological disorders.
Within oncology, that evolution is already reshaping the market. New approvals and label expansions are arriving more frequently, while ADCs initially developed for advanced cancers are being studied across broader tumor types and earlier lines of treatment. As their role in cancer care expands, so too does the complexity involved in bringing these therapies to more patients, across more indications and markets.
