Batch Disposition: The Brake Pedal on Manufacturing Output

Dispositioning a batch to be released to market sits at the intersection of quality, operations, and patient access, which makes it one of the most important decisions a manufacturer makes — and also one of the most painful. In too many life sciences organizations, release decisions are slowed not by product risk, but by manual review effort, disconnected systems, and legacy assumptions about what "good" looks like. The result is a process that functions like a brake pedal on manufacturing output: slowing release, tying up inventory, and delaying therapies for reasons that have nothing to do with quality.

The Technological Gap

The technological gap we see every day is pretty stark.

• On one hand, the life sciences industry is advancing rapidly — developing increasingly complex biologics and cell and gene therapies, applying artificial intelligence (AI) and machine learning (ML) to new drug discovery, and operating across complex global networks of internal sites and external partners.
• On the other hand, many batch disposition processes are still rooted in assumptions that made sense decades ago: single-site manufacturing, limited data collection, and paper-first workflows. The cognitive dissonance of saying "we're pushing the boundaries of modern science" while also saying "we still rely on 100% manual review because that's how it's always been" or "these systems don't talk, so just add another day or two to review" would be comical if the consequences weren't so real – and completely avoidable.

Learn more about the technological limitations impacting batch disposition in BioPhorum's Batch Disposition Manifesto.

The Real Cost: Second- and Third- Order Effects

Here's a few examples of the second- and third- order effects a poor batch disposition strategy can have:

• Operational Delay: Quality assurance (QA) teams spend days or weeks compiling, reconciling, and rechecking data that already exists in validated systems. Release cycle times stretch, inventory in your finished good warehouse piles up, and production capacity is artificially constrained.
• Introduction of More Errors: Worse, manual work doesn't just slow things down — it introduces new risk through transcription errors, fragmented context, and inconsistent interpretation.
• Delay in Access to Care: Obviously, this is the most important consequence. In autologous cell therapies, where a single patient's cells are manufactured, tested, and returned on a tightly coordinated schedule, release delays can mean a missed treatment window. In radiopharmaceuticals and short-shelf-life biologics, where potency or usability is measured in hours or days, added review time erodes therapeutic value. Even in hospital-dependent specialty medicines, release delays have cascading ramifications for clinical schedules and care coordination. In an industry where treatment windows are sometimes measured in hours, how do we still accept batch release cycles measured in weeks or months?

As manufacturing scales and data volumes increase, manual batch review simply doesn't scale with it. Disconnected manufacturing execution system (MES), learning information management system (LIMS), quality management system (QMS), and enterprise resource planning (ERP) systems force humans to act as the integration layer, stitching together spreadsheets and documents just to reconstruct what already happened. That effort adds time, not insight.

A Better Way

There is growing alignment across the industry that this model needs to change. Frameworks like the BioPhorum Batch Disposition Manifesto articulate a shared direction: moving from fragmented, manual, documentation-heavy release toward connected, data-driven, and risk-based batch disposition.

The target state:

• IS NOT about eliminating quality oversight or "auto-releasing" product.
• IT IS about letting technology handle aggregation, reconciliation, and routine verification so quality professionals can focus on true exceptions.

In this model, review by exception becomes the norm, data integrity is built in at the source, and release decisions are faster precisely because they are more confident.

Read the complete BioPhorum Batch Disposition Manifesto to learn how your organization can move your batch release process toward data-driven, risk-based batch disposition.

Foundational Principles

• Achieving this vision depends on a small set of foundational principles.
• Processes must be standardized before they are digitized. For manufacturers with a global footprint, an upfront acknowledgement and research into the disparate regulatory frameworks across the world is a must. Research first, build once.
• Data must be structured, contextualized, and traceable across systems. Platforms must interoperate rather than operate in silos.
• Compliance must be embedded, not bolted on. De-risk batch manufacturing as early as possible (think at template creation) not at the time of closing each discrete batch.
• Start small and expand — prove value through pilots and build trust over time.

Crawl, Walk, Run: A Practical Path Forward

We've spoken with some MasterControl customers about "crawl, walk, run" and how it applies to real-time release. Our advice is always the same: let's start small, iterate quickly, and get more mature in our capabilities.

• Crawl: Basic digitization with an electronic batch record (EBR).
• Walk: All product lines are paperless, review by exception is crisp, and only true exceptions are reported.
• Run: Real-time release is possible, thanks to the deep process understanding, live monitoring and other guardrails we have in place.

Many organizations will operate hybrid models for years, applying real-time release where risk profiles and product characteristics allow while maintaining traditional approaches elsewhere. Even crawling is orders of magnitude better than standing stagnant!

Learn how your organization can start taking a "crawl, walk, run" approach to your batch release processes by reading BioPhorum's Batch Disposition Manifesto.

Where to Start: Practical Steps

Modernizing batch disposition doesn't require a wholesale system overhaul. Your organization can get started with:

• Process Harmonization: Examine core batch release processes across sites, defining what truly constitutes an exception, and integrating data flows between MES, LIMS, and QMS.
• Pilot Programs: Piloting electronic batch records, automated data aggregation, or digital deviation workflows creates immediate operational relief while building confidence.
• Change Management: helping quality teams understand that digital tools reduce noise, not accountability.

We're all part of a value chain – an ecosystem of players helping get more life-saving products to market faster. So let's share what we learn, eliminate redundant, non-value-add rechecks, and work on more transparent data exchanges.

Conclusion

Batch disposition doesn't have to be an operational bottleneck. When designed intentionally, it becomes a strategic operational and quality advantage — one that accelerates product release, strengthens compliance, and improves patient access.

New and better ways exist – are we brave enough to want to try? Best of luck on your digitization journey!

To read the complete BioPhorum Batch Disposition Manifesto and explore the detailed framework for digital transformation, visit: https://www.biophorum.com/download/batch-disposition-a-shared-vision-and-practical-framework-for-digitized-transformation/