Expert Panel Discussion on Platform Analytical Procedures, beyond the technical challenges

This summary accompanies a recent expert forum discussion organised by BioQC. We appreciate the panellists’ time and expertise. The views expressed by the panellists are their personal interpretations and do not represent the positions of their respective organisations.

This panel discussion explored the practical implementation of platform analytical procedures as introduced under ICH Q14 and ICH Q2(R2).

Defining Platform Methods: Pragmatism Over Prescription

The discussion opened with one of the most frequently raised questions in the field: what actually constitutes a platform analytical procedure? Rather than relying solely on the regulatory definition, panellists advocated for a pragmatic working interpretation. If a method allows samples from different products to be tested within the same analytical run, it qualifies as a platform method in operational terms. This framing proved useful precisely because the concept itself is not entirely new. Analytical scientists have long applied similar methods across multiple products; what ICH Q14 introduces is a formal framework that unlocks new options, most notably abbreviated validation, for methods meeting this description.

The decision to formally designate a method as a platform should be driven by whether that designation confers genuine advantage. Abbreviated validation represents the primary benefit, but it carries corresponding obligations. Once a method is designated as platform across development and commercial quality control settings, the knowledge underpinning the validation strategy must be shared and maintained across all products and sites using that method. This connectivity requirement means that designating a method as platform is a strategic commitment, not merely a labelling exercise, and organisations should assess whether the lifecycle benefits justify that commitment before proceeding.

Panellists offered several illustrative examples. mRNA products were highlighted as a strong candidate for platform methods, since certain physical and chemical properties, and therefore certain analytical methods, may be entirely independent of the mRNA sequence. Host cell protein methods occupy a grey zone: they may

function as platform methods where the same antibodies and standards apply across products, but the degree of platformisation achievable depends heavily on whether manufacturing processes are sufficiently similar to produce comparable residual host cell protein profiles. Compendial methods represent a further category where platformisation is already embedded by design, with general chapters providing a pre-validated foundation that only requires demonstration of suitability for the specific product context.

Methods relying on product-specific immunological tools, such as those employing distinct antibodies targeting different antigens, present the greatest challenge and were identified as unlikely candidates for platformisation across products, though they may still qualify as platform methods when applied across different stages of the same product’s manufacturing process.

What Must Be in Place Before Applying a Platform Method to a New Product

Rather than offering a fixed checklist, panellists emphasised that readiness for platformisation depends fundamentally on how the platform method came to exist. Two distinct pathways were described, each with different starting conditions and development requirements.

Where a method has already been validated and is in routine use, an opportunistic approach applies. Existing performance data from the original product provide a substantial foundation. The analytical target profile for the new product’s critical quality attribute can be compared against measured performance on the original product, and a risk assessment can then determine whether any differences between the two products are likely to affect method performance. If the risk assessment is favourable, development work on the new product is effectively accelerated, beginning not from a blank sheet but from a method already eight or nine tenths of the way to fitness for purpose. Additional validation work focuses on confirming that the existing performance characteristics hold, rather than characterising the method from scratch.

Where the platform is being built by design from the outset, the analytical target profile is constructed with platformisation as an explicit objective. The method is challenged during development using a representative selection of products anticipated to reflect the diversity the platform will eventually need to accommodate. Starting with a small number of representative products, building robust hypotheses, and then re-challenging the method against additional products at a later development stage was recommended as a more reliable approach than attempting to design for the full anticipated range of product diversity from the beginning. The first platform development of this kind will carry a modest additional cost compared with conventional method development, estimated at around ten to twenty per cent, but subsequent additions to the platform will be substantially faster and less costly, delivering increasing returns as the product portfolio grows.

In both cases, the emphasis throughout was on fitness for purpose rather than optimisation. A method that delivers reliable, validated performance for every product it covers, even if not individually optimised for each, represents a successful platform. Where a specific product exhibits greater variability under the platform method, practical solutions such as duplicate sample preparation for that product can restore fitness for purpose without dismantling the platform structure.

Splitting Platform Methods: Partial Platformisation as a Practical Tool

A practical question raised by attendees concerned whether only part of a method can be designated as platform while other components are treated as product-specific. Panellists confirmed that this approach is both valid and already in use. Methods can be meaningfully divided, most commonly between a sample preparation stage and an instrumental readout stage, with platformisation applied where scientifically defensible and product-specific validation retained where not.

The value of this approach lies in its flexibility. Even where sample preparation must be adapted for a specific product, if the instrumental readout remains common across products, the ability to run multiple products in the same analytical sequence is preserved and throughput benefits accrue. The extent to which abbreviated validation can be applied will differ depending on which components are shared and which are not, and the validation strategy must clearly delineate these boundaries. However, the business case for partial platformisation can still be compelling, particularly where the alternative is to maintain entirely separate methods and the associated resource burden in quality-control settings.

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