Close

Innovate UK – funded biotech company accelerates cheaper drug and vaccine manufacture after biocomputer breakthrough

Note* - All images used are for editorial and illustrative purposes only and may not originate from the original news provider or associated company.

Related stories

Billerud Introduces New Pharmaceutical Packaging Option

Billerud has officially introduced PharmaKraft, a specialized fibre-based packaging...

AstraZeneca Advances AI Drug Discovery Deal with insitro

AstraZeneca has inked a billion-dollar AI drug discovery partnership...

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. ...
- Advertisement -

An Innovate UK-backed biotech company has achieved a pioneering biocomputer breakthrough which is accelerating the development and manufacture of cheaper drugs and vaccines.

BiologIC Technologies, inventor of the world’s first biocomputer, has developed 3D printed ‘lab-on-a-chip’ platforms – miniaturised devices that integrate multiple laboratory functions onto a single chip.

These enable faster, more efficient, and cost-effective analysis of biological samples, with applications ranging from drug testing to point-of-care diagnostics.

Thanks to Analysis for Innovators (A4I), a grant funding programme run by Innovate UK, the UK’s innovation agency, BiologIC was able to access the expertise and advanced equipment of the National Measurement Laboratory (NML) hosted at LGC.

As a result the Cambridge-based company has achieved a massive leap in its understanding of how the plastic materials used in 3D printing the chips interact with biological applications.

It is now able to demonstrate greater biocompatibility and stability of its ‘lab-on-a-chip’ which means pharmaceutical manufacturers and Contract, Design and Manufacturing Organisations (CDMOs) can now speed up the work needed before developing minimum viable products, which will ultimately lead to faster time-to-market and cheaper drugs and vaccines.

Commenting on BiologIC’s experience of the A4I programme, Dr Colin Barker, Chief Scientific Officer at BiologIC Technologies, said: “Without access to the high-end analytics, and, more critically, the world class expertise at NML made possible through the A4I funding, it would likely have taken us several years to achieve the same insights.

“We’ve already taken the learning we’ve gained from the grant and applied it in real time. We have several active projects, where we have directly applied our new knowledge to improve customer outcomes. This grant directly led to an increase in our understanding, which has had an immediate impact, and greater commercial success.”

3D printed materials, without any post-processing, simply do not support reproducible biology.

For BiologIC to support its customers in developing and manufacturing high-quality biological products, it had to first understand the chemical interactions between the 3D printed materials and biological samples.

“By the nature of them being 3D printable materials, they’re very reactive,” Barker explained. “And so, part of Biologic’s proprietary know-how is how to take those materials and treat them to make them biocompatible. But that’s a very complex, very slow process.”

But the pioneering technology company – which has been taking products to market since 2020 – did not have the funds or specific expertise required for full investigation of these interactions.

“Our customers are trying to produce advanced biology products at scale with robust reproducibility,” Barker added. “The greater understanding of our materials through the A4I grant allows us to standardise and streamline our production methodologies, delivering reproducible results at a lower cost.

“Personalised medicines by their nature don’t have economies of scale, and price tags can run into millions of pounds per patient. The BiologIC platform provides the paradigm shift in automation technologies required to enable disruptive economics and democratise access to these new therapies.”

The BiologIC platform is already generating value for advanced developers at customer sites. The BiologIC team works closely with customers to create custom configurations of its platform, addressing customer challenges including increasing yield, process robustness and scale.

Analysis for Innovators (A4I), run by Innovate UK, the UK’s innovation agency, helps businesses access cutting-edge R&D and expertise of skills and equipment at nine national measurement centres across the country. The grant funding is also extended to all or some of the project costs.

Simon Yarwood, Knowledge Transfer Manager – Industrial Technologies, A4I at Innovate UK KTN, said: “The transformation of BiologIC is yet another success story generated by A4I. It is an effective demonstration of how we empower companies to boost their productivity and their competitiveness by solving difficult technical analysis-type problems that maybe they’ve been battling with for some time.

“And we introduce them to some unique partner organisations, like NML, who have world class skills and unique facilities. That allows them to look at problems in a new way, and then help solve them.”

A4I has been running since 2016 and brings together nine national centres of excellence in measurement, tackling challenges affecting existing processes, products or services. Across nine rounds of funding, it has supported over 250 companies resulting in over £600M of benefit for those businesses, such as increased productivity and turnover, reduced waste, and the creation of new and upskilled jobs.

Never miss a pharmaceutical headline

The pharmaceutical industry moves fast – stay on top of it with our must - read briefings.

  • The top pharma and life sciences stories, straight to your inbox
  • The biggest news, features, interviews, and analysis
  • Dedicated coverage of the key developments driving the global pharmaceutical sector

Subscribe

- Never miss a story with notifications

- Gain full access to our premium content

- Browse free from any location or device.

Media Packs

Expand Your Reach With Our Customized Solutions Empowering Your Campaigns To Maximize Your Reach & Drive Real Results!

– Access the Media Pack Now

– Book a Conference Call

– Leave Message for Us to Get Back

Latest stories

Related stories

Billerud Introduces New Pharmaceutical Packaging Option

Billerud has officially introduced PharmaKraft, a specialized fibre-based packaging...

AstraZeneca Advances AI Drug Discovery Deal with insitro

AstraZeneca has inked a billion-dollar AI drug discovery partnership...

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. ...

State of API & Peptide CDMO Capacity

Pharmaceutical companies planning peptide or complex small-molecule launches are...

Subscribe

- Never miss a story with notifications

- Gain full access to our premium content

- Browse free from any location or device.

Media Packs

Expand Your Reach With Our Customized Solutions Empowering Your Campaigns To Maximize Your Reach & Drive Real Results!

– Access theMedia Pack Now

– Book a Conference Call

– Leave Message for Us to Get Back

Translate »