By combining Lateral Dx’s advanced assay development capabilities with BBI Solutions’ ISO 13485-certified, scalable manufacturing infrastructure, the partnership enables customers to move from concept to commercial-scale production with reduced development timelines and enhanced product performance.

Under the agreement:

Lateral Dx will lead the design and optimisation of high-performance lateral flow assays, leveraging advanced antibody screening services, reader technologies, novel materials, quantitative development capabilities, and user-centric design principles.

BBI Solutions will provide end-to-end manufacturing, quality assurance, and regulatory support from its state-of-the-art facilities in Crumlin, ensuring consistent quality and scalability.

“The lateral flow diagnostics market continues to expand beyond traditional applications, and customers need partners who can deliver both innovation and manufacturing excellence,” said Mat Hobbs, Chief Commercial Officer at BBI Solutions. “Lateral Dx brings proven expertise in pushing the boundaries of sensitivity and specificity, which complements our track record of producing over 25 million diagnostic components annually. This partnership creates a genuinely streamlined pathway from initial design to commercial launch.”

“This partnership marks a significant milestone for Lateral Dx and addresses a critical need in the diagnostics industry,” added Richard Campbell, Managing Director at Lateral Dx. “By integrating our agile development approach with BBI’s proven manufacturing infrastructure, we’re creating a truly turnkey solution that dramatically reduces time-to-market and technical risk for our customers.”

The collaboration is already underway with several development projects, and a major commercial program is planned for 2026. This initiative will progress through full development to scaled production, showcasing the partnership’s ability to deliver end-to-end solutions that meet real-world diagnostic needs.

Both companies are committed to advancing global health through accessible, reliable diagnostics and will continue integrating emerging technologies—from enhanced signal amplification to next-generation materials and device formats—to maintain their competitive edge in the rapidly evolving lateral flow market.

About BBI Solutions

BBI Solutions is a trusted global provider of high-quality reagents and IVD manufacturing services. With decades of experience supporting diagnostic developers and manufacturers, BBI’s facilities are ISO 13485-certified and designed to deliver scale, consistency, and technical excellence throughout product lifecycles.

About Lateral Dx

Lateral Dx specialises in lateral flow assay development, transforming complex diagnostic challenges into practical, market-ready solutions. Based in Alloa, Scotland, the company’s expertise spans advanced conjugate chemistry, novel detection methods, and user-centric design, serving clients across human health, veterinary, food safety, and environmental sectors.

Media Contacts:

BBI Solutions Pamela Pirrit, Marketing Director, pamelapirrit@bbisolutions.com +44(0)7946 105594

Lateral Dx Richard Campbell Managing Director technical@lateraldx.com +44(0)1259 793041

The modern glucose sensor faces a fundamental trade-off: high-turnover enzymes like glucose dehydrogenase (GDH) deliver the sub-5-second response times markets demand, but their enhanced activity often comes at the cost of long-term stability. While traditional glucose oxidase (GOx) can maintain activity for years in proper storage, early GDH formulations frequently showed significant degradation much sooner.

This “speed-versus-stability” dilemma has driven intensive formulation research, yielding sophisticated stabilization strategies that now routinely extend high-activity enzyme shelf life beyond 24 months. Through strategic use of glassy sugars, protective proteins, advanced matrices, and controlled packaging environments, today’s rapid-response glucose strips can match or exceed the stability of their slower predecessors.

The key insight: enzyme stability isn’t predetermined by molecular structure – it’s engineered through intelligent formulation design.

The Shelf-Life Paradox: Why Faster Can Mean Frailer

High catalytic efficiency typically correlates with structural flexibility. The same conformational dynamics that enable rapid substrate turnover can make enzymes more susceptible to thermal denaturation, oxidative damage, and moisture-induced degradation. PQQ-dependent GDH variants, despite their impressive activity advantage over GOx (up to 25x in one study referenced in our whitepaper), historically showed accelerated activity loss under standard storage conditions.

Early versions of PQQ-GDH had stability issues and lost activity faster than GOx when exposed to elevated temperatures or humidity stress. The enzyme’s enhanced flexibility, while beneficial for catalysis, creates more opportunities for irreversible unfolding and cofactor dissociation. This biological reality initially limited the adoption of high-speed enzymes in applications requiring extended shelf life.

However, this vulnerability is a formulation challenge, not an insurmountable limitation. Modern stabilization science has transformed enzyme preservation from art to engineering discipline, enabling rational design of protective matrices that preserve both activity and kinetics over extended periods.

Mechanisms of Decay You Must Arrest

Understanding degradation pathways guides effective countermeasures. Three primary mechanisms threaten glucose enzyme stability in dried test strip formats, whether you are looking at using GOx or GDH:

Thermal Denaturation & Cofactor Loss: Elevated temperatures cause protein unfolding and release of essential cofactors like FAD or PQQ. Even modest temperature excursions during shipping or storage can initiate irreversible structural changes.

Oxidative Self-Damage: Glucose enzymes often generate reactive species (H₂O₂ from GOx, quinone radicals from GDH) that can attack amino acid residues. Trace metal contamination catalyzes these oxidative reactions, accelerating enzyme degradation.

Moisture Plasticization: Water uptake softens dried enzyme films, increasing molecular mobility and accelerating chemical reactions. The transition from glassy to rubbery state dramatically reduces stability.

Each degradation mode requires specific protective strategies, leading to the layered defense approach that characterizes successful long-term formulations.

Four Layers of Formulation Defense

Layer 1: Glassy Sugars & Polyols Trehalose, sucrose, and glycerol act as preferential hydration agents, replacing water molecules around the enzyme surface and forming a rigid glassy matrix upon drying. This “water replacement hypothesis” explains trehalose’s exceptional stabilizing power – it maintains the enzyme’s hydration shell while eliminating the mobility that enables degradation reactions.

Layer 2: Protective Proteins & Polymers Bovine serum albumin (BSA), casein, and synthetic polymers provide molecular crowding effects that stabilize native enzyme conformations. These macromolecules also act as sacrificial targets for oxidative species and can chelate trace metals that catalyze degradation. Synergistic combinations – such as sucrose plus gelatin – often outperform individual components.

Layer 3: Cross-linking & Immobilization Chemical cross-linking with glutaraldehyde or more biocompatible alternatives creates covalent networks that lock enzymes in stable conformations. While excessive cross-linking can reduce initial activity, optimal conditions preserve both activity and dramatically extend operational lifetime.

Layer 4: Advanced Encapsulation Sol-gel silica matrices, alginate hydrogels, and polymer nanofibers provide physical barriers against environmental stress while maintaining substrate accessibility. These approaches are particularly valuable for sensors requiring long-term in vivo stability.

Ready to dive deeper into enzyme kinetics optimization and stability strategies? Download our comprehensive white paper “Optimizing Enzyme Kinetics for Glucose Determination in Diabetes Assays” for detailed stability strategies, validated performance data, and regulatory considerations that will streamline your next enzyme decision.

[Download Full White Paper]

Packaging & Environmental Control

Even perfectly formulated enzymes require protective packaging to achieve multi-year shelf life:

Lyophilization Excellence: Proper freeze-drying with optimized lyoprotectants enables commercial GOx to retain specifications for 36 months at -15°C. The key lies in controlled nucleation, optimal freezing rates, and complete moisture removal without overheating.

Barrier Packaging Systems: Desiccant-containing vials with metallized barrier films maintain low water activity essential for stability. FDA-cleared glucose strips using this strategy demonstrate 2.2-year room-temperature shelf life – proving that ambient storage is achievable with proper moisture control.

Open-Vial Stability Management: Each vial opening introduces moisture that must be managed. Successful formulations include excess stabilizer capacity and design films that rapidly re-equilibrate to low water activity after brief exposure.

The packaging strategy must be integrated with formulation design – no amount of desiccant can compensate for inadequate intrinsic stability, while even robust formulations fail without moisture protection.

Speed-vs-Stability in Practice: A hypothetical 

Imagine a team that swapped slow-but-rugged GOx for lightning-fast GDH to hit a 3-second read time. The prototype wowed Product Management – until stability trials crashed at nine months. By reformulating with a trehalose-BSA-alginate matrix, they restored ≥90 % activity after a 180-day 45 °C stress test, a proxy for 24 months on the shelf. The launch stayed on schedule, and the per-strip enzyme load actually dropped because GDH turnover remained sky-high. Stability work paid for itself twice: longer dating and lower reagent cost. This is possible with innovative stability strategies.

Decision Checklist: Are You Formulation-Ready?

Green Light Indicators: Your formulation achieves ≥90% activity retention after 6-months stress testing at 45°C (an industry proxy for 2-year room temperature performance, using the Arrhenius Equation). Enzyme kinetics (Km, kcat) remain within ±10% of initial values throughout accelerated aging. No secondary chemistry degradation detected.

Yellow Flags: Mediator or buffer components degrade faster than the enzyme itself – this chemistry-limited scenario requires addressing the weakest link rather than over-engineering protein protection. Or moisture uptake exceeds an acceptable level during standard humidity exposure, indicating insufficient glassing or inadequate packaging barriers.

Red Stops: Accelerated aging reveals >15% shifts in Km values, suggesting fundamental changes in enzyme-substrate interaction that cannot be corrected through recalibration. Visible precipitation or color changes indicate severe formulation incompatibility requiring complete reformulation.

Critical QC Metrics to Monitor:

• Residual moisture
• Glass transition temperature (Tg) 
• Peroxide scavenger capacity
• pH stability throughout aging (buffer capacity validation)

Regulatory Snapshot

Documentation Requirements: CLSI EP25 guidelines mandate both real-time and accelerated stability data for FDA and IVDR submissions. Regulatory agencies consistently reject shelf-life claims lacking robust supporting evidence, making comprehensive stability studies non-negotiable rather than optional.

Process Change Vigilance: Seemingly minor modifications – new stabilizer grade, adjusted cross-linker concentration, or alternative drying conditions – can trigger requirements for bridging studies to demonstrate continued equivalence. Smart development teams validate stability margins early and document all process parameters to avoid regulatory surprises.

Global Considerations: Different markets may have varying temperature exposure expectations. Products destined for tropical climates require more aggressive stabilization strategies than those for temperate regions.

Key Takeaways

• High-speed enzymes CAN achieve a long shelf life when protected through layered formulation strategies combining glassy matrices, protective proteins, and controlled packaging environments
• Stability engineering pays double dividends – longer product dating improves commercial competitiveness while reducing lot-release testing frequency and inventory management complexity
• Treat formulation as a core R&D discipline, not a last-minute optimization. Early stability work prevents costly reformulation delays during regulatory submission
• Validate protection mechanisms systematically – each stabilization layer should demonstrate measurable benefit through accelerated aging before moving to combination studies
• Package integration is essential – even robust formulations require moisture protection and temperature control to achieve full stability potential

You no longer need to choose between speed and stability. With disciplined application of modern formulation science, glucose sensors can deliver both rapid response times and extended shelf life -enabling the next generation of diabetes monitoring technology.

Ready to implement proven stability strategies? Download our comprehensive white paper “Optimizing Enzyme Kinetics for Glucose Determination in Diabetes Assays” for detailed stability strategies, validated performance data, and regulatory considerations that will streamline your next enzyme stability strategy.

[Download Full White Paper]

Why kinetics come first

Every reading your glucose strip or CGM produces begins with a single catalytic event. If that event happens too slowly, too fast, or under the wrong conditions, accuracy drifts and ISO 15197 compliance slips. Three kinetic parameters-Km, kcat, and oxygen-dependence (or lack thereof)-do most of the damage. Nail them early and downstream verifications move faster; miss them and you will bleed time in redesigns, re-calibration, or regulatory queries.

Below we unpack each parameter, show how it skews performance in the real world, and outline proven levers-many of which BBI’s enzyme portfolio already puts at your fingertips.

1. Match Km to the Clinical Range to Protect Linearity

What goes wrong
Km is the glucose concentration at which the reaction rate is half of Vmax. Wild-type A. niger GOx sits in the 33–110 mM band—comfortably above physiological glucose—so signal remains proportional across 1–25 mM blood levels. Drop into an engineered low-Km oxidase and you risk saturating the enzyme around 15 mM, compressing the upper half of your calibration curve and producing high-bias readings in hyperglycemia.

Control Levers

Quick Check

Plot sensor signal vs. 0–30 mM glucose after five seconds. If the slope falls off before 20 mM, reassess Km or mediator diffusion.

Additional Quick-Check Tips

1. Run duplicate strips in 5% O₂ and 21% O₂
   • If only the low-O₂ data go nonlinear, the culprit is oxygen dependence (GOx).
   • If both curves break, focus on Km or mediator concentration.
2. Log current density (µA cm⁻²) vs. glucose, not raw meter output

   Normalising for electrode area makes results portable between lab cells, pilot strips, and production lots.

Some caveats to remember:

• Integration vs. snapshot: Some meters integrate charge over 5 s rather than reading an instantaneous current. If yours does, set your potentiostat integration window to match.
• Temperature drift: Km and diffusion coefficients shift with temperature. Keep the plate at 30 ± 0.5 °C or run at both 25 °C and 37 °C so surprises don’t appear during stability trials.
• High-glucose edge cases: ICU and dialysis samples can exceed 30 mM; consider extending the curve to 40 mM if those markets matter.

You’ll know within half an hour whether to tweak Km by picking a different enzyme grade or to open the mediator/diffusion throttle instead.

2. Exploit kcat without breaking diffusion limits

What goes wrong
Higher turnover (kcat) shortens response time, but only until the reaction becomes limited by glucose or mediator diffusion. PQQ-GDH clocks 5 000–10 000 U mg⁻¹-≈25× GOx-yet if the strip’s diffusion path can’t feed it, signal plateaus early and meter electronics mis-time the endpoint.

Control levers

• Calibrate kcat to strip architecture – For a five-second finger-stick meter, activity around 700 U mg⁻¹ (modern fungal GDH-FAD) hits time-to-read targets without starving itself.
• Right-size enzyme mass – Fast enzymes need less protein; trimming load lowers strip cost and reduces batch-to-batch variability.
• Balance mediator kinetics – A kcat boost is pointless if the ferro/ferricyanide couple lags; adjust mediator concentration to keep the electron shuttle rate higher than Vmax.

BBI advantage
Because BBI manufactures multiple grades of GOx and GDH under ISO 13485, you can order the same activity grades you screened in R&D at production scale-avoiding the “re-code every new lot” headaches of commodity supplies.

3. Remove oxygen dependence to erase altitude and haematocrit bias

What goes wrong
GOx consumes O₂. At high glucose or low ambient O₂ (capillary specimens at altitude, CGM tissue sites), the reaction slows, artificially lowering readings. Mediated strips reduce but do not eliminate the effect; CGMs feel it most because tissue O₂ is ~⅓ arterial.

Control levers

1. Go oxygen-independent. Modern GDH-FAD transfers electrons directly to a mediator, making the assay insensitive to O₂ swings-if interference is engineered out.
2. Engineer specificity back in. Protein-engineered GDHs now match GOx’s glucose exclusivity [reference specificity of a BBI GDH product].
3. Validate under stress. Run accuracy panels at 5 % and 21 % O₂, across 20-60 % haematocrit. If bias changes by > ±2 mg dL⁻¹ between conditions, revisit enzyme choice.

Pulling it together-A kinetics checklist for your next design review

1. Map Km vs. clinical range – ensure proportionality at the extremes.
2. Benchmark kcat to diffusion – faster isn’t always better.
3. Stress-test oxygen effects – if GOx passes, fine; if not, move to GDH.
4. Lock supplier consistency – insist on ISO 13485, batch COAs showing activity and Km.
5. Document lot-control strategy – regulators want traceability as much as accuracy.

Where to go deeper

This post cherry-picked the highlights. The full  whitepaper “Optimizing Enzyme Kinetics for Glucose Determination in Diabetes Assays” contains:

• Comparative Km/kcat tables for 9 enzyme variants
• Shelf-life curves for stabilised vs. unstabilised formulations
• Regulatory checklists you can paste into a 510(k)
• All the data sources

Want the full picture? Download our free White Paper on diabetes biosensors for deeper insights.

Access your whitepaper

The World Health Organization (WHO) has released a new Target Product Profile (TPP) to guide the development of in vitro diagnostic tests for serious bacterial infections in infants aged 0–59 days, including neonatal sepsis, which accounts for 15% of newborn deaths globally.

Key insights from the WHO report:

• 2.3 million newborns die annually, mostly in low- and middle-income countries.
• 84% of infection-related deaths could be prevented with early diagnosis and appropriate treatment.
• Current diagnostics (e.g., blood cultures, molecular tests) can be slow, expensive, and impractical in many settings.

WHO calls for rapid, low-volume, point-of-care tests that can be used in both hospital and primary care environments. Biomarkers like CRP and Procalcitonin are highlighted as part of hospital-based diagnostic algorithms, but they are not yet widely accessible or validated for use in all settings.

Why This Matters for Diagnostic Developers working in Neonatal Sepsis Testing

The WHO TPP outlines both essential and desirable characteristics for new tests, essential characteristics include:

• High sensitivity (≥90%) and specificity (≥70–80%)
• Fast turnaround time (≤30 minutes)
• Low hands-on time (<10 minutes)
• Use of low blood volumes (≤100μL)

These criteria are designed to support clinical decision-making, reduce unnecessary antibiotic use, and help prevent antimicrobial resistance.

Supporting Innovation in Sepsis Diagnostics

At BBI, we provide validated antibodies and antigens for key inflammatory markers, including CRP and IL-6 antibodies:

• PIS – Interleukin 6 (IL-6) Antibody

Developed to the highest quality standards under ISO13485, and with immunoassay performance including Lateral Flow for assurance in point-of-care application testing.

For more bespoke, innovative needs, our decades of antibody development expertise can help. Our mission is to help support diagnostic developers and researchers globally in working for better health outcomes.

📚 Read the WHO TPP Guidance: In vitro diagnostic tests for serious bacterial infection, including neonatal sepsis, among infants aged 0–59 days: target product profile

🔗Contact BBI: Contact us

This year marks a major milestone for BBI as we proudly celebrate 70 years of continuous contribution and leadership from our Cape Town site — the foundation and strength behind BBI’s enzyme manufacturing legacy.

Established in 1954, this facility is BBI’s longest-standing site and a vital part of our global operations. Over the decades, it has grown into a strategic manufacturing hub, producing a diverse portfolio of native enzymes and proteins used in diagnostic assays worldwide.

Among these is horseradish peroxidase (HRP), with production now exceeding 30 billion units annually — a clear testament to the site’s scale and its impact on the global in vitro diagnostics (IVD) industry.

To commemorate this incredible journey, we hosted a celebration event on 23rd May, bringing together local employees, members of the BBI leadership team, supplier partners, and government representatives.

“This site reflects our long-term commitment to advancing diagnostics, together — powered by people, strengthened by partnerships, and anchored in a shared purpose to improve health and save lives through sustainable innovation.”

Alex Socarrás, Group CEO, BBI Solutions

We continue to innovate and partner with our suppliers to drive sustainable practices through monitoring systems, utilizing solar infrastructure and enhanced quality systems. BBI are proud to be investing in a future that is sustainable, secure, and science-led.

As we look ahead to the next 70 years, we extend our deepest gratitude to our people, partners, and community for being an essential part of our journey to advance health, together.