New position paper argues that fragmented data, broken scientific handoffs, and outdated tech transfer models are turning Chemistry, Manufacturing, Controls (CMC) into a billion-dollar bottleneck
CAMBRIDGE, Mass. and CAMBRIDGE, England, Sept. 2, 2026 /PRNewswire/ — The biopharma industry has invested heavily in accelerating discovery. AI, machine learning (ML), high-throughput experimentation and advanced modelling are helping scientists identify promising therapeutic candidates faster than ever.
But there is a problem.
Before any therapy can reach patients, it must pass through Chemistry, Manufacturing and Controls, or CMC. And that pathway is struggling to keep pace.
In its new position paper, “The Billion-Dollar Bottleneck: Why CMC is Strangling the Biopharma Pipeline,” Zifo argues that CMC has become one of the industry’s most consequential operational constraints. The paper examines how scientific complexity, fragmented data, manual documentation, and poorly connected tech transfer processes are delaying commercialization and consuming valuable scientific capacity.
The stakes are significant. CMC deficiencies have contributed to 74% of FDA Complete Response Letters (CRLs), while every day of delayed prescription sales may represent about $800,000 in lost value, according to the paper. For therapies approaching fixed patent-expiry dates, those delays cannot always be recovered later. They can permanently reduce an asset’s commercial life.
Yet the impact reaches well beyond revenue.
“CMC delay is often discussed as an operational or regulatory problem. It is both, but that framing is incomplete,” said Raj Prakash Govindarajan, Chief Executive Officer and Co-Founder at Zifo. “When process and manufacturing knowledge cannot move at the speed of the science, patients wait longer, facilities remain underutilized and highly trained scientists spend their time reconstructing information that should already be connected.”
A Modern Scientific Pipeline Running on Fractured Infrastructure
The challenge has intensified as biopharma pipelines have shifted from comparatively predictable small-molecule processes toward biologics, cell and gene therapies, nucleic-acid therapeutics and other advanced modalities.
These therapies introduce hundreds, sometimes thousands, of potentially influential process, material, equipment and environmental variables. Small changes in mixing, oxygen transfer, pH, temperature, shear or raw materials can affect the behaviour and quality of the final product.
The science has changed. Much of the operating model has not.
Critical information still moves between process development, analytical teams, quality functions, manufacturing sites, and external partners through spreadsheets, PDFs, paper batch records, slide decks and email. Context is lost at every handoff. Scientists then spend hours finding data, reconciling sample identifiers and manually rebuilding experimental histories.
The paper describes this as the “Data Janitor” epidemic, with current operational analyses indicating that PhD-level scientists may spend between 30% and 40% of their working time on data cleanup and reconciliation rather than scientific problem-solving.
Digitizing Paper Is Not Transformation
The viewpoint also challenges a familiar response to CMC friction: purchasing another platform.
Replicating an inefficient paper process on a screen does not remove the underlying problem. It can make the process more rigid. In dynamic scientific environments, systems built around fixed templates and isolated workflows can restrict experimentation and encourage scientists to return to spreadsheets or paper simply to get the work done.
Instead, Zifo proposes a scientist-centered CMC operating model built around six connected moves:
- Liberate evidence trapped in batch records, certificates of analysis, PDFs and legacy reports.
- Connect the most valuable data choke points across instruments and scientific systems.
- Rewire Design-Make-Test-Analyse (DMTA) workflows so context travels with every sample and result.
- Create an orchestration layer that adapts to scientists without replacing validated systems of record.
- Apply governed Scientific Language Models grounded in proprietary CMC evidence.
- Treat tech transfer as a continuous knowledge flow, not a late-stage baton pass.
The ambition is substantial: reduce overall CMC cycle times by as much as 40%, with phase acceleration of up to 60%. Achieving that goal will require more than incremental optimization. It will demand a joint operating model across CMC, IT, Quality and data teams, supported by targeted lighthouse projects that demonstrate value quickly and scale under appropriate governance.
“CMC does not need another digital filing cabinet,” said Paul Denny-Gouldson, Chief Scientific Officer at Zifo and a co-author of the position paper. “It needs an operating environment in which scientific evidence and knowledge remain connected, decisions can be made faster and remain traceable, and tech transfer readiness begins on day one. The bottleneck is not inevitable. But removing it requires the industry to stop incrementally improving individual fragments and redesign the entire process flow and how the science is done.”
Download the position paper
The full viewpoint examines the causes and costs of the CMC bottleneck and presents a practical blueprint for building a connected, AI-enabled and scientist-centred CMC ecosystem. https://zifo.com/cmc-million-dollar-bottleneck-biopharma/
About Zifo
Zifo is the leading global enabler of AI and data driven enterprise informatics for science driven organizations. With extensive solutions and services expertise spanning research, development, manufacturing, and clinical domains, we serve a diverse range of industries, including Pharma, Biotech, Chemicals, Food and Beverage, Oil & Gas, and FMCG. Trusted by over 190 science-focused organizations worldwide, Zifo is the partner of choice for advancing digital scientific innovation. https://zifo.com/
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