Chromatography has long been recognized as one of the most critical steps in downstream bioprocessing. When evaluating chromatography operations, many manufacturers naturally focus on resin selection, column performance and process optimization. Yet one aspect of chromatography often receives far less attention than it deserves: the true cost of packing columns in-house.

For many organizations, self-packing has been the default approach for decades. It provides a high degree of control and allows teams to prepare columns on demand using existing equipment and expertise. However, as biologics manufacturing becomes faster, more complex and increasingly resource constrained, many manufacturers are beginning to question whether self-packing remains the most effective use of their time, facilities and personnel.

The cost of self-packing extends far beyond resin and hardware. Hidden throughout the process are operational expenses, resource commitments and scheduling risks that can significantly impact manufacturing efficiency.

Looking beyond the obvious costs

The assumptions that shaped downstream manufacturing twenty years ago are not necessarily the assumptions that support today's bioprocessing facilities. Manufacturing campaigns are shorter, product portfolios are broader and facilities are increasingly expected to accommodate changing priorities with minimal disruption. Activities that once represented sensible operational practice deserve periodic reassessment as manufacturing objectives evolve. Column preparation is one such activity, particularly where flexibility, responsiveness and efficient use of specialist expertise have become strategic priorities.

When organizations compare chromatography solutions, the first figure they often consider is the cost of resin. High-value media such as Protein A resins represent a substantial investment, making them an obvious focus during procurement and process development. However, resin is only one component of the overall cost of preparing a chromatography column.

Every packing operation requires skilled operators, buffer preparation, equipment setup, packing execution, qualification testing, documentation and quality review. Each of these activities consumes valuable manufacturing resources before a single litre of product has been purified.

While these costs may appear manageable when viewed individually, together they represent a significant investment of both time and operational capacity.

The hidden cost of expertise

One of the most overlooked aspects of self-packing is the reliance on specialist knowledge. Although standard operating procedures define packing methods, successful column packing depends on experience that cannot always be documented. Experienced operators recognise subtle differences in slurry behaviour, pressure profiles and bed formation that influence whether a column will successfully meet qualification criteria.

Many manufacturing sites naturally develop one or two individuals who become recognized as the "column packing experts." They understand the nuances of different resin types, know how to troubleshoot unexpected behaviour and can identify problems before they become critical.

While this expertise is invaluable, it also creates organisational dependency. If key personnel are unavailable due to annual leave, illness, retirement or changing roles, organisations can quickly discover that a critical manufacturing capability relies on very few individuals. Technology transfers between sites can present similar challenges when practical experience has not been fully captured.

Operational burden that extends beyond packing

From an operational perspective, resilience is increasingly becoming as important as efficiency. Manufacturing organizations benefit from reducing reliance on individuals whose experience cannot easily be replaced or transferred. Processes that depend heavily on tacit knowledge may perform exceptionally well under normal conditions, but they can become vulnerable when organizations grow, expand internationally or experience changes in personnel. Building resilience therefore means designing manufacturing systems that are repeatable, transferable and less dependent on individual expertise.

Column packing is often perceived as a single manufacturing task. In reality, it is a series of interconnected activities that require careful coordination.

Before packing begins, resin must be prepared, buffers manufactured, equipment assembled and documentation completed. Following packing, qualification testing must confirm that the column meets predefined acceptance criteria before manufacturing can proceed.

If everything goes according to plan, this process may appear straightforward. However, not every packing attempt is successful. Should a column fail qualification, operators may need to unpack the column, recover the resin, prepare fresh buffers and repeat the entire process. Additional documentation, engineering support and quality review can further extend the timeline.

The consequences rarely affect chromatography alone. Manufacturing schedules may need to be adjusted, cleanroom occupancy increases and equipment remains unavailable for other activities while the issue is resolved.

Facility resources are valuable assets

Modern bioprocessing facilities are under increasing pressure to maximize utilization. Dedicated packing skids, slurry tanks, pumps, lifting equipment and cleanroom space all represent valuable infrastructure that requires maintenance, validation and availability whenever column packing is performed. In flexible manufacturing environments supporting multiple products, these assets are shared across numerous programmes.

Every hour devoted to column preparation is an hour that facilities, equipment and operators cannot be used for manufacturing activities that directly contribute to product production.

As manufacturers continue to adopt modular facilities and single-use technologies to improve operational efficiency, activities that occupy valuable infrastructure are being carefully re-evaluated.

Perhaps the more important question is not how much column preparation costs, but what manufacturers are choosing not to do while those resources are committed elsewhere. Every organization operates with finite engineering capacity, manufacturing expertise and cleanroom availability. When these resources are occupied by preparation activities, they are unavailable for process optimisation, technology transfer, troubleshooting or manufacturing execution. The opportunity cost of those decisions is often difficult to quantify, but it is no less real.

Not every resin packs the same

Adding further complexity is the wide variety of chromatography media used throughout downstream purification. Compressible agarose resins require carefully controlled compression and flow conditions to achieve consistent bed formation. Rigid polymeric media demand different packing approaches focused on flow distribution and bed uniformity.

More specialized materials, such as ceramic hydroxyapatite (CHT), require particularly careful handling to minimize mechanical stress and avoid generating fines that can compromise chromatographic performance.

Maintaining expertise across multiple resin families can be challenging, particularly as manufacturing programmes diversify and new purification technologies are introduced.

The most expensive cost is delay

Perhaps the greatest hidden cost of self-packing is one that rarely appears in project budgets. Delay.

A manufacturing suite waiting for a qualified chromatography column is not producing product.

Operators assigned to repeat packing activities are unavailable for manufacturing operations.

Engineering resources become focused on troubleshooting rather than process improvement.

Production schedules shift, placing additional pressure on quality, planning and supply chain teams.

The financial impact of these delays often exceeds the direct cost of packing itself, particularly within GMP manufacturing where facility time is exceptionally valuable.

Across the biopharmaceutical industry, organizations are increasingly distinguishing between activities that create competitive advantage and those that support it. This distinction is shaping decisions around outsourcing, automation and specialist partnerships. Rather than asking whether an activity can be performed internally, manufacturers are increasingly asking whether performing it internally delivers the greatest strategic value. Column preparation is becoming part of that broader conversation.

Rethinking the role of column preparation

None of this suggests that self-packing is the wrong approach for every organization. Many manufacturers possess excellent internal expertise and have established robust packing procedures that consistently deliver high-quality results. However, the decision to self-pack should be based on a realistic assessment of total operational cost rather than equipment ownership alone.

Manufacturers should consider questions such as:

• Does column packing rely on a small number of specialist operators?
• Could manufacturing resources be better deployed elsewhere?
• How much facility time is devoted to preparation rather than production?
• What is the impact if a packing attempt fails?
• How much operational flexibility is lost while preparing columns?

Historically, biomanufacturers sought to develop expertise across every aspect of process development and manufacturing. Today, that definition of core competency is evolving. Increasingly, competitive advantage lies in accelerating development, transferring processes efficiently and bringing therapies to patients faster. As a result, organizations are reassessing where specialist partners can enhance operational performance while allowing internal teams to focus on activities that directly influence product quality, process innovation and clinical success.

A strategic decision rather than a technical task

As biologics manufacturing continues to evolve, operational agility has become a competitive advantage. Facilities are expected to support multiple products, respond to changing clinical schedules and maximize manufacturing capacity while maintaining consistent quality.

Looking ahead, downstream manufacturing will be defined by how effectively organizations deploy their people, infrastructure and operational expertise. As manufacturing becomes increasingly agile, the greatest competitive advantage will likely come from ensuring that internal resources remain focused on the activities that create the greatest scientific and commercial value. Viewed through that lens, column preparation becomes part of a broader strategy for manufacturing excellence.

By understanding the hidden costs associated with self-packing, manufacturers can make more informed decisions about how best to deploy their expertise and resources - ensuring that valuable downstream teams remain focused on what matters most: delivering life-changing therapies to patients.