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Scientists demonstrate method to find new therapies

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Managing Quality and Regulatory Risks in Pharmaceutical Technology Transfer

Technology transfer moves more than manufacturing instructions. It moves process knowledge, supplier dependencies, labeling requirements, packaging specifications, and the evidence needed to demonstrate control. For medical device manufacturers, including those supporting drug-device combination products, these interfaces can become recurring sources of compliance gaps during site transitions, acquisitions, and remediation. The central problem is often not a missing procedure. It is a quality system that allows connected activities to change independently. A label revision may be approved while packaging artwork, supplier instructions, or production-system data still reflect an obsolete version. Staying inspection-ready requires manufacturers to manage these dependencies as one controlled system. Why Compliance Gaps Keep Recurring Findings are treated as documentation defects Revising a procedure can resolve an immediate discrepancy without changing the behavior that caused it. If unclear decision rights, weak escalation, or ineffective training remain, the same failure may surface elsewhere. Corrective and preventive action should distinguish the observed finding from its underlying cause and establish how effectiveness will be demonstrated. Ownership is divided across connected functions Quality, Regulatory Affairs, labeling, packaging engineering, operations, suppliers, and digital-system owners often maintain separate workflows. Each team may complete its assigned task while an interface remains uncontrolled. For example, changing an instruction for use can affect packaging configuration, translations, technical documentation, inventory disposition, and release controls. Transitions expose unresolved weaknesses Acquisitions and site transfers can introduce conflicting procedures, incomplete knowledge transfer, or different assumptions about validated processes. Regulatory changes add further demands. When these events coincide with CAPA or change-control backlogs, teams may prioritize administrative closure over risk reduction. Without a coordinated impact assessment, local fixes can create new gaps downstream. Establish the Regulatory Baseline Inspection readiness starts with knowing which requirements apply to the product, activity, and market. Pharmaceutical, device, and combination-product obligations are not interchangeable; transfer planning should identify the applicable requirements rather than assume one quality framework covers every operation. According to FDA’s Quality Management System Regulation overview and FAQs, the QMSR became effective on February 2, 2026, incorporates ISO 13485:2016 by reference, and introduced the updated device inspection process under Compliance Program 7382.850. ISO 13485 certification does not exempt a manufacturer from FDA inspection or guarantee compliance with FDA requirements. For devices marketed in the European Union, Regulation (EU) 2017/745, Annex I, Section 23, provides the primary requirements for information supplied with devices, including labels and instructions for use. Teams should assess the applicable provisions alongside relevant language, product-specific, and market requirements. A labeling review should therefore evaluate required content and consistency with the device’s intended purpose and supporting documentation—not merely artwork accuracy. How to Identify the Real Gaps Begin with a cross-functional assessment that follows actual product and information flows. Select representative transfers, label changes, supplier changes, and CAPAs, then trace each from initiation through implementation and effectiveness review. Map dependencies: Identify affected specifications, suppliers, packaging components, systems, validation activities, and training. Compare records with practice: Check whether approved procedures match what operators and reviewers actually do. Test traceability: Follow a requirement through technical documentation, labeling, production instructions, and release evidence. Examine recurrence: Look for repeated deviations, reopened actions, overdue changes, and findings shared across sites. Assess capacity: Determine whether qualified owners have enough time and authority to complete corrective work. Prioritize gaps by potential patient or user harm, regulatory impact, likelihood of recurrence, and detectability. Document the rationale; an old overdue item is not automatically more important than a newly identified high-risk weakness. Align Quality, Labeling, Packaging, and Change Control Create a coordinated remediation plan with one accountable owner for each action, named contributors, acceptance criteria, and required evidence. Separate immediate containment from systemic correction. Containment might prevent obsolete labels from being issued; correction might redesign approval and implementation controls so obsolete versions cannot return. Use change control as the integration point. Before approval, evaluate effects on regulatory submissions or notifications, technical documentation, supplier controls, packaging performance, validation, electronic master data, inventory, and training. Record both identified impacts and justified decisions that particular activities are unaffected. During technology transfer, define readiness gates before production or release responsibilities move. These should address the transfer of process knowledge, acceptance criteria, receiving-site capability, required qualification or validation, approved documents, and personnel competence. The appropriate evidence depends on the product and process; a generic checklist cannot replace a documented assessment. Finally, verify implementation where the work happens. Confirm that current instructions are available, suppliers received approved requirements, systems contain correct versions, and affected personnel can perform their tasks. A signed approval is not evidence that every downstream change took effect. Mistakes That Undermine Inspection Readiness Closing CAPAs on task completion alone: Effectiveness checks should test whether the underlying failure has been controlled. Updating labels in isolation: Assess packaging, supplier, system, documentation, and inventory consequences. Counting closures instead of evidence: Dashboards need defensible records behind their status indicators. ...
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Scientists at The Scripps Research Institute (TSRI) have demonstrated the power of a new drug discovery technique, which allows them to find – relatively quickly and cheaply – antibodies that have a desired effect on cells. The TSRI scientists used the technique to discover two antibodies that protect human cells from a cold virus.

The finding includes the useful insight that the cold virus can be stopped by targeting a key viral enzyme in just the right way. More importantly, the study highlights the broad potential of this discovery method to find new ways to fight infections, cancers and other diseases, and perhaps even aging.

“This method allows you to find antibodies that prevent cell death – in this case virus-induced cell death, but potentially any kind of cell death,” said Richard A. Lerner, Institute Professor at TSRI. Lerner was the senior author of the study, which is reported online ahead of print on January 16, 2014 by the Cell Press journal Chemistry & Biology.

Bigger Pond, Better Fish

For the past two decades, Lerner and his TSRI laboratory have helped pioneer techniques for discovering antibodies that can be used as therapies or scientific tools. Humira®, now among the world’s top-selling pharmaceuticals, is one of many products that have been discovered using such techniques.

Recently, the Lerner laboratory developed an advanced technique in which hundreds of millions of distinct antibodies are produced artificially within very large cultures of mammalian cells. Scientists can use such a system to swiftly find any antibodies that cause a desired outcome (“phenotype”) in the cells where they reside.

Scientists for decades have applied similar “phenotypic selection” methods to libraries of standard small-molecule compounds. But the antibody libraries that can be used with the new method are orders of magnitude larger, making them much more likely to contain members that can achieve a desired result in cells.

“Small-molecule libraries generally contain only tens to hundreds of thousands of compounds, whereas with this method we can use libraries with more than a billion distinct antibodies,” said Jia Xie, a staff scientist in the Lerner laboratory who was first author of the new study.

The new method gives scientists more power not only to find new antibody-based therapies, but also to discover the biological pathways through which they work-pathways that may turn out to be more easily and cheaply targeted by small-molecule drugs.

Earlier this year, Lerner, Xie and their colleagues reported using the new method to find an antibody that can perform the remarkable trick of turning bone marrow cells into young brain cells, via a previously unknown signaling mechanism.

For the new study, the team set out to do a proof-of-principle selection of antibodies that can bring about a different effect: protecting cells against an otherwise certain death. In this case, the agent of death was a rhinovirus, a respiratory virus that is the most common cause of ordinary colds. This rhinovirus reliably kills HeLa cells, a line of human-derived cells that have long been used in studies of viral infection.

Evolving a Discovery, Round by Round

To begin, the team used harmless lentiviruses to distribute the genes for about 100 million distinct antibodies among a similar number of HeLa cells, and later exposed the cells to the rhinovirus. So lethal was this virus to the HeLa cells that nearly every cell soon died, overwhelmed by the infection despite any protective effect from antibodies they harbored.

To detect a protective effect, Xie and his colleagues knew that he would have to make the selection process less drastic. Thus, for the next test, instead of selecting cells that survived – for none would have survived – they selected cells that showed delayed signs of impending death. The researchers then harvested the antibody genes these cells contained, and distributed them among a fresh set of cells. In this way, they reasoned, the genes for the antibodies that had exerted a protective effect would become more abundant within the cells.

Xie and his colleagues took the cells through three of these selection rounds – each requiring about ten days of working and waiting – but saw dismayingly few signs of progress. “The cells that had been infected with our antibody library still showed marginal to undetectable differences from the control cells,” he said.

Then in the fourth round, the protective antibodies became abundant enough to bring about a dramatic change: almost all the antibody-containing cells survived, whereas all the control cells died.

The protection turned out to come from just two antibodies out of the original pool of roughly 100 million. The team determined that both these antibodies protected the cells by attaching to the 3C protease, a rhinovirus enzyme, in ways that hindered its infection-enabling activity.

In principle, if further tests bear out the protective effects of the two antibodies, then optimized versions of them, or small-molecule drugs that hit the same target, could be developed as treatments for rhinovirus infections.

But Xie noted that the study was mainly about demonstrating the usefulness of this broad new method.

“It’s a fast, economical, multi-round selection scheme that enables scientists to identify functional antibodies from an unusually big library,” he said. “As long as we have a way to detect and select a desired phenotype in the test cells, this method lets us fish out the antibodies that can make the phenotype happen.”

The study also shows the power of the new method to illuminate biological pathways that mediate disease – in this case the activity of the rhinovirus 3C protease. Moreover, it offers unprecedented insight into the selection process itself.

 

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Managing Quality and Regulatory Risks in Pharmaceutical Technology Transfer

Technology transfer moves more than manufacturing instructions. It moves process knowledge, supplier dependencies, labeling requirements, packaging specifications, and the evidence needed to demonstrate control. For medical device manufacturers, including those supporting drug-device combination products, these interfaces can become recurring sources of compliance gaps during site transitions, acquisitions, and remediation. The central problem is often not a missing procedure. It is a quality system that allows connected activities to change independently. A label revision may be approved while packaging artwork, supplier instructions, or production-system data still reflect an obsolete version. Staying inspection-ready requires manufacturers to manage these dependencies as one controlled system. Why Compliance Gaps Keep Recurring Findings are treated as documentation defects Revising a procedure can resolve an immediate discrepancy without changing the behavior that caused it. If unclear decision rights, weak escalation, or ineffective training remain, the same failure may surface elsewhere. Corrective and preventive action should distinguish the observed finding from its underlying cause and establish how effectiveness will be demonstrated. Ownership is divided across connected functions Quality, Regulatory Affairs, labeling, packaging engineering, operations, suppliers, and digital-system owners often maintain separate workflows. Each team may complete its assigned task while an interface remains uncontrolled. For example, changing an instruction for use can affect packaging configuration, translations, technical documentation, inventory disposition, and release controls. Transitions expose unresolved weaknesses Acquisitions and site transfers can introduce conflicting procedures, incomplete knowledge transfer, or different assumptions about validated processes. Regulatory changes add further demands. When these events coincide with CAPA or change-control backlogs, teams may prioritize administrative closure over risk reduction. Without a coordinated impact assessment, local fixes can create new gaps downstream. Establish the Regulatory Baseline Inspection readiness starts with knowing which requirements apply to the product, activity, and market. Pharmaceutical, device, and combination-product obligations are not interchangeable; transfer planning should identify the applicable requirements rather than assume one quality framework covers every operation. According to FDA’s Quality Management System Regulation overview and FAQs, the QMSR became effective on February 2, 2026, incorporates ISO 13485:2016 by reference, and introduced the updated device inspection process under Compliance Program 7382.850. ISO 13485 certification does not exempt a manufacturer from FDA inspection or guarantee compliance with FDA requirements. For devices marketed in the European Union, Regulation (EU) 2017/745, Annex I, Section 23, provides the primary requirements for information supplied with devices, including labels and instructions for use. Teams should assess the applicable provisions alongside relevant language, product-specific, and market requirements. A labeling review should therefore evaluate required content and consistency with the device’s intended purpose and supporting documentation—not merely artwork accuracy. How to Identify the Real Gaps Begin with a cross-functional assessment that follows actual product and information flows. Select representative transfers, label changes, supplier changes, and CAPAs, then trace each from initiation through implementation and effectiveness review. Map dependencies: Identify affected specifications, suppliers, packaging components, systems, validation activities, and training. Compare records with practice: Check whether approved procedures match what operators and reviewers actually do. Test traceability: Follow a requirement through technical documentation, labeling, production instructions, and release evidence. Examine recurrence: Look for repeated deviations, reopened actions, overdue changes, and findings shared across sites. Assess capacity: Determine whether qualified owners have enough time and authority to complete corrective work. Prioritize gaps by potential patient or user harm, regulatory impact, likelihood of recurrence, and detectability. Document the rationale; an old overdue item is not automatically more important than a newly identified high-risk weakness. Align Quality, Labeling, Packaging, and Change Control Create a coordinated remediation plan with one accountable owner for each action, named contributors, acceptance criteria, and required evidence. Separate immediate containment from systemic correction. Containment might prevent obsolete labels from being issued; correction might redesign approval and implementation controls so obsolete versions cannot return. Use change control as the integration point. Before approval, evaluate effects on regulatory submissions or notifications, technical documentation, supplier controls, packaging performance, validation, electronic master data, inventory, and training. Record both identified impacts and justified decisions that particular activities are unaffected. During technology transfer, define readiness gates before production or release responsibilities move. These should address the transfer of process knowledge, acceptance criteria, receiving-site capability, required qualification or validation, approved documents, and personnel competence. The appropriate evidence depends on the product and process; a generic checklist cannot replace a documented assessment. Finally, verify implementation where the work happens. Confirm that current instructions are available, suppliers received approved requirements, systems contain correct versions, and affected personnel can perform their tasks. A signed approval is not evidence that every downstream change took effect. Mistakes That Undermine Inspection Readiness Closing CAPAs on task completion alone: Effectiveness checks should test whether the underlying failure has been controlled. Updating labels in isolation: Assess packaging, supplier, system, documentation, and inventory consequences. Counting closures instead of evidence: Dashboards need defensible records behind their status indicators. ...

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