Late-stage customization – what does it mean for the pharmaceutical industry?

In recent years, the pharmaceutical industry has had to meet increasing regulatory requirements and dynamically changing market expectations. Personalization and flexibility in this sector are becoming crucial, also in the context of patient safety. Counterfeit medicines have become a serious issue, posing significant risks to patients and consumers. In the European Union, regulations have been implemented to ensure patient and consumer safety by preventing the illegal introduction of falsified medicines into the supply chain. The serialization of prescription drugs became mandatory in the EU on February 9, 2019, requiring a system for tracking and monitoring medicines throughout the supply chain. The next step is aggregation, which links serialized unit packages of medicinal products packed in cartons to higher levels of collective packaging and then to the pallet level, assigning them a unique serial number. Countries such as Turkey, Egypt, and India have already implemented such solutions. Since 2020, aggregation has also become mandatory in the Commonwealth of Independent States (CIS) and Pakistan. In the following years, Japan, Brazil, South Africa, and the USA joined these countries. The lack of product aggregation means a ban on exporting to the listed countries. In response to these challenges, the concept of late-stage customization, i.e., the personalization of pharmaceutical products at a late stage of production, is gaining increasing importance.

Definition and essence of late-stage customization

Late-stage customization is a process that allows for the adaptation of packaging, labels, and other elements of a pharmaceutical product just before its distribution. This enables manufacturers to flexibly respond to specific market requirements while minimizing costs and the risk of losses.

In the traditional production model, each batch of drugs is prepared in advance for a specific market, requiring prior planning of packaging, labels, and leaflets in the appropriate language. However, in the late-stage customization model, these elements can be adapted at a later stage, increasing efficiency and avoiding issues related to unpredictable demand.

In the European Union, pharmaceutical products must meet various packaging and labeling requirements depending on the target country. Moreover, the introduced regulations on drug serialization and aggregation require strict tracking throughout the supply chain. In the traditional approach, any change in labeling meant production had to be halted, leading to downtime and increased costs. Late-stage customization allows for quick and flexible adaptation of medicines to different markets without interrupting production processes at earlier stages.

Modern technologies and the growing popularity of contract packaging outsourcing play a key role in implementing this model. They enable the rapid adaptation of packaging even for very small batches of drugs, which is extremely important in a dynamically changing market. As a result, pharmaceutical companies can not only optimize their logistics processes but also introduce products to the market faster and better adapt to changing regulations and patient needs.

Prespack's services include packaging, repackaging, serialization and aggregation, labeling, and medical kit preparation. Late-stage customization is a significant part of our activities and is particularly important in the turbulent market situation currently observed, where demand for specific products changes very dynamically. Thus, bright stock (the process of manufacturing and storing pharmaceutical products supplied by the manufacturer in unmarked unit packages, not yet intended for a specific market) at Prespack becomes a highly desirable solution for companies seeking flexible solutions. Furthermore, the need to meet serialization regulations is an essential factor for the development of the late-stage customization concept.

At Prespack, we also provide services for pharmaceutical manufacturers, assembling medical kits for various EU markets from semi-finished products imported to us. This is a significant advantage for these companies, as the so-called late-stage customization process takes place with us. How does it work? The company assigns quantities, e.g., syringes or autoinjectors, to the final product packaging based on its specific demand for individual European markets. We provide the necessary components and packaging materials and create the finished product for the client. We also perform this service for products requiring storage at temperatures of 2–8 degrees Celsius (cold chain). This is possible thanks to our cold chamber, which allows us to store up to 300 pallets.

Benefits of late-stage customization

Implementing a late-stage customization strategy in the pharmaceutical industry brings numerous benefits, optimizing the supply chain, reducing costs, and ensuring drug production compliance with regulations.

One of the key advantages of this approach is increased production and distribution flexibility. By enabling packaging and label customization just before distribution, manufacturers can quickly respond to market and regulatory changes, avoiding the need to store large quantities of finished products tailored to specific countries.

If serialization and late-stage customization take place immediately before packaging, significant savings in storage and logistics costs can be achieved, as efforts related to procurement, storage, and logistics management are minimized.

Late-stage customization enhances supply chain flexibility, allowing product adaptation to specific local market requirements in a short time without maintaining large stocks of packaging and labels.

Additionally, creating ready-made packages before their final adaptation eliminates the need to produce smaller batches for individual markets, enabling larger product series production and thereby reducing the unit cost per product.

The benefits of this model are visible not only to manufacturers but also to patients. Faster adaptation of medicines to local market requirements means better product availability and more efficient distribution. Thanks to late-stage customization, pharmaceutical companies can not only streamline their operational processes but also better meet patient needs and dynamically respond to evolving market demands.

Challenges and limitations

Despite numerous benefits, late-stage customization also involves challenges that may hinder its implementation. A key aspect is ensuring the appropriate technological infrastructure, including modern digital printing systems, purchasing serialization and aggregation machines, validating serialization system connections with the contractor's system, maintaining an active system environment, backup systems, and keeping trained personnel.

Logistics also becomes more complex – managing small product batches requires precise order coordination and maintaining stock for all components, managing changing packaging artwork, and ensuring storage and transport of personalized medicines meet specific standards. Therefore, many manufacturers choose to collaborate with contract packaging companies that have the necessary technological background and experience in executing this process.

Summary

Late-stage customization is a concept that significantly influences how medicines are produced and distributed, offering manufacturers greater flexibility, cost reduction, and regulatory compliance.

Given the requirements for drug serialization and aggregation, implementing late-stage customization is becoming not just an option but often a necessity for pharmaceutical companies aiming to compete in international markets.

The future of the pharmaceutical industry is heading towards greater personalization and automation of production processes. Therefore, companies that decide to implement a late-stage customization strategy today can gain a competitive advantage and better respond to the needs of a dynamically changing market. It is worth analyzing the benefits of contract packaging outsourcing and choosing a trusted partner for cooperation.