Is your packaging strategy keeping up with fragmented pharma manufacturing?
Marc Martens
Small molecule pharmaceutical manufacturing is changing. As companies diversify production geographically and rely increasingly on specialized manufacturing partners, active pharmaceutical ingredients (APIs) and bulk drug products travel through more facilities before reaching their final destination.
While these developments can improve manufacturing flexibility and access to specialist capabilities, they also introduce operational complexity. Every additional transfer creates another opportunity for delays, handling errors or quality deviations.
For pharmaceutical manufacturers and suppliers, this raises an important question: How do you maintain consistent control over critical materials when manufacturing is spread across multiple sites and organizations?
The growing complexity of small molecule supply chains
Two developments are reshaping the manufacturing landscape.
First, governments in Europe and the United States are encouraging pharmaceutical companies to diversify their production networks and reduce dependence on established manufacturing regions in Asia.
Second, increasingly complex APIs require specialized production capabilities. Highly potent active pharmaceutical ingredients (HPAPIs), for example, demand sophisticated containment equipment and specialist expertise that are not available at every manufacturing facility.
As a result, pharmaceutical companies are increasingly working with contract development and manufacturing organizations (CDMOs), distributing different manufacturing stages across multiple locations.
This approach provides access to specialist capabilities, but it also creates more interfaces between facilities, processes and quality systems.
Every handoff introduces new risks
Moving pharmaceutical materials between manufacturing sites involves much more than transportation.
At each destination, containers must be received, inspected, potentially sampled and entered into storage before the material can be released for further processing. These activities may be repeated several times as a product progresses through the manufacturing network.
Research indicates that technology transfers to CDMOs can take almost six months longer than transfers between internal manufacturing sites [1].
Additional handling also increases the potential for operational deviations. These may include:
- Physical damage: Repeated lifting, stacking and repositioning can damage containers or compromise their integrity.
- Contamination risks: Opening containers for sampling or inspection introduces additional opportunities for contamination or product exposure.
- Material degradation: Extended storage and variable environmental conditions can affect moisture-sensitive APIs and other critical materials.
- Quality-related delays: Damaged packaging or questionable inspection results can trigger investigations, additional testing and delayed material release.
Even when the product itself remains suitable for use, resolving such issues consumes valuable time and resources.
Standardization creates control across manufacturing networks
As supply chains become more fragmented, eliminating transfers between facilities is rarely realistic. Access to specialist capabilities, regional production requirements and manufacturing flexibility all contribute to the need for distributed production.
The challenge is therefore not necessarily to reduce the number of manufacturing partners, but to reduce unnecessary variation between them.
This is where a consistent bulk secondary packaging strategy can make a difference.
Unlike manufacturing processes, which may vary considerably between facilities, packaging can remain standardized throughout the product journey.
By establishing common packaging specifications across multiple sites and partners, pharmaceutical companies can support more predictable handling, storage and transfer practices.
This approach also makes it easier to define consistent expectations for product protection, closure performance and packaging quality, regardless of where materials are manufactured or processed.
Choosing packaging for the complete product journey
Packaging that performs well during a single shipment may not necessarily be suitable for a journey involving extended storage, repeated handling and multiple manufacturing partners.
A more strategic approach considers the entire product lifecycle, including:
- Mechanical resilience: Packaging must withstand repeated handling, stacking and transportation.
- Reliable closure: Containers should support secure opening and resealing when sampling or inspection is required.
- Material protection: Appropriate barrier performance and containment help protect sensitive or highly potent materials.
- Documented performance: Relevant test data, GMP assurance and UN certification where required support qualification and compliance.
- Consistent availability: Reliable packaging specifications and supply across manufacturing locations help reduce operational variation.
Selecting packaging against these requirements helps manufacturers establish more consistent processes and minimize avoidable disruptions throughout their supply chains.
Build resilience into every handoff
The growing fragmentation of small molecule manufacturing is changing how pharmaceutical companies manage production, quality and supply chain performance.
While packaging cannot eliminate the complexity of distributed manufacturing, it can help organizations maintain greater control over the movement and protection of critical materials.
By treating bulk secondary packaging as a strategic operational tool rather than simply a container, pharmaceutical manufacturers and suppliers can create more reliable handoffs and strengthen supply chain resilience.
Is your packaging strategy ready for the new reality of small molecule manufacturing?
Download CurTec's white paper, The new reality of small molecule manufacturing and shipping, to explore the forces reshaping pharmaceutical supply chains, the risks associated with increased material movement and the role of packaging in building more resilient manufacturing networks.
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Reference
PharmaSource (2024) - Tech transfer in pharma: Guide to technology transfers and key processes - https://pharmasource.global/content/tech-transfer-in-pharma-guide-to-technology-transfers-and-key-processes
