Shaping the future of Diagnostics: our commitment for ...

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Shaping the future of Diagnostics: our commitment for better healthcare

Transcript of Shaping the future of Diagnostics: our commitment for ...

Shaping the future of Diagnostics: our commitment for better healthcare

Imagine fiberwe have only seen the beginningof what fiber-based materialsand solutions can be used for

Our Company at a glance

Where do we play a role in diagnostics?Biosamples Collection & Preservation

Our portfolio offers simple, cost effective and reliable collection, transportation and storage of biosamples at ambient temperature. Minimal volumes for analysis, less equipment required and basic skills, all features which make our cards ideal to be used in any kind of environment and circumstances.

We aim at developing innovative fiber-based materials for diagnostic applications, improve access to healthcare and contribute to the development of next-generation diagnostic technologies.

MISSIO

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8.000 employees worldwide

Global leader in fiber based materials, including solutions for Life Sciences

We are experts in fiber-based solutions finding application in various fields of Life Sciences: screening of infectious diseases, forensic sciences, agrigenomics, genomics, wellness, clinical and veterinary diagnosis

Global network of sales offices, 45 plants and converting sites in 14 countries

VISIO

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Our ambition is to be at the forefront of the advanced patient-centric healthcare revolution.

PASSIO

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We do business with purpose, we listen to the voice of our customers and accommodate their needs in the best possible way.

Components of IVD Devices

We offer a wide range of high quality sample, conjugate and absorbent pads as well as blood separation media specifically designed for use in flow-through and lateral flow assays, as well as dipstick devices.

Driving force of Dried Blood Spots technology

Infectious diseases diagnosisMeasuring HIV viral loads and monitoring the efficiency of

antiretroviral treatments are rarely available in resource-limited

countries because of the high cost and stringent requirement

for transport and storage of biosamples. With a few microliters

of whole blood dried on filter paper, DBS technology provides

a sustainable alternative for low technology settings with

limited access to laboratory facilities. Thanks to ambient

transport through conventional mail, our specimen collection

cards improve access to vulnerable patient groups living in

non-urban areas and ensure better therapy monitoring.

AgrigenomicsGenotyping applications are extremely valuable for genetic

and parental identification in order to manage selective

breeding efforts, identify markers linked to desirable traits,

define pedigree and track farm of origin. We are dedicated

to advance the future of agrigenomics through innovative

products, collaborations, and interaction with the community.

Our flexible, sustainable and cost-effective solutions for samples

collection and automated high throughput processing help

researchers and breeders in the challenging task of feeding

the population with healthier crops and livestock.

Forensic SciencesThe continuous progress of forensic investigation technologies

requires the development of less invasive procedures for

screening and sampling of small volumes. DBS technology has

become the preferred method for DNA samples collection for

human genetics and forensic DNA identification. The reduced

size of DBS allows easy storage of biosamples at ambient

temperature, a key factor for forensic laboratories which

typically handle a significant amount of samples simultaneously.

Our product offering including long-term ambient DNA

preservation and customized kits not only impacts the way

samples are collected, transported and stored, but also allows

analysis from samples that might otherwise remain untested.

BiobankingBiological samples collected and stored in biobanks are a

significant resource of data with huge research potential for

finding markers used in early detection of diseases which are

still curable. Today, test tubes with large volumes of blood

or plasma are kept in energy-consuming freezers. The use

of our specific treated fiber-based solutions offers a novel

approach to biosamples storage. It also represents an

ideal resource for large biobanking population studies of

patients in areas that lack appropriate infrastructure for

processing blood and a cold chain

for the transportation and storage

of blood products.

Ahlstrom-Munksjö specimen collection cards portfolio is designed for microvolume sampling, transport and stabilization of

biospecimen at ambient temperature. We are committed to continuously support our customers and partners by providing

innovative fiber-based solutions. Our various options for customized products further help us to specifically address our customers’

needs.

Ambient preservation of DNA for high qualityand reliable analysis

Ahlstrom-Munksjö GenSaver™ 2.0 and GenSaver™ Color 2.0 specimen

collection cards allow collection, transport and long-term preservation

of DNA with high recovery for high quality STR and NGS data.

Ahlstrom-Munksjö GenReleaz™ and GenReleaz™ Color specimen

collection cards allow collection, transport, preservation and fast

elution of DNA from biological fluids stored at ambient temperature.

Our specimen collection cards are manufactured in accordance to

the ISO 18385:2016 standard to avoid any risk of human amplifiable

DNA contamination.

AutoCollectTM cards have a cassette design dedicated to laboratory

automated equipment. These cards are made with a high purity

paper grade suitable for HPLC/MS analysis of a wide range of

analytes. Automation in the various steps of DBS sample processing

has shown strong advantages, including: improved traceability of

operations, volume control and accuracy of timing.

GenSaverTM 2.0Long-term stabilization of

DNA at ambient temperature

GenReleazTM

Fast and simple DNA elution

Our BioSample cards are designed for uniform and reproducible

samples collection, simple extraction and reliable analysis of targeted

molecules like nucleic acids, proteins, vitamines and hormones. These

cards are manufactured according to the rigorous standards set by

ISO 13485:2016 and ISO 9001:2015 to ensure high quality. They are

CE marked in EU as In Vitro Diagnostic device, in compliance with

the Directive 98/79/EC.

High quality automated design for high-throughput testing

Easy and rapid collection for reliable biomarkers analysis

What we offer- Innovation & Customization

Dried Blood Spot technology is the future of convenient home blood testing: a microvolume of blood sample is collected directly

onto a specimen collection card, transported to the laboratory and preserved at ambient temperature prior to analysis. In recent

years, the use of DBS has gained increasing interest compared to the conventional collection and analysis of liquid samples and

has been extensively utilized in healthcare, especially in challenging environments. This technology leads to a simplification of the

blood collection process and a significant reduction of the costs involved.

1. FLEXIBLE SELF-COLLECTIONPatient collect a blood sample from finger prick onto the card in any environment. No appointment, no travel to the clinic, no line.

2. SAFE HANDLINGEasily handling at ambient temperature without special packaging. No biohazardous risks as pathogens are inactive in the dried samples.

3. SIMPLIFIED TRANSPORTATIONThe cards can be posted by mail through simplified logistic. No cold chain and specific transport..

4. COST-EFFECTIVE STORAGESamples are stable and easy to store at ambient temperature. Less space, cost and energy consumption.

5. RELIABLE ANALYSISQualitative and quantitative analyses with microvolumes of biosamples processed through automated workflow. Higher accuracy for reliable analysis.

6. VALIDATED DATAData are delivered directly to smartphones as part of patients lifestyle changes.

A sustainable technology for accurate results at affordable prices

Driving force for rapid diagnostic test

Clinical DiagnosisWorldwide demand for decentralized availability of diagnostic

tests is increasing as the potential for pathogen exposure and

diseases are always present. Because of their ease of use

and portability, LFA testing are used in multiple diagnostic

industries and clinical testing scenarios. By providing a real-

time result, time is saved compared to a laboratory test or is

a helpful tool to direct further laboratory testing in hospitals.

At home, the most widely used LFA tests are for pregnancy

and ovulation, infectious diseases, cholesterol, and urine

analysis strips. They offer flexibility for individuals who do not

wish to be tested in public health settings. Moreover, with the

development of oral fluids based testing, LFA use becomes

convenient to patients due to the noninvasive nature of the

specimen collection.

Food & Beverage TestingSafety of food has always been a priority for food and

beverage manufacturers. However, during the past three years,

safety issues have led to even more stringent legislation in

food safety requirements to ensure food safety for consumer

protection. In this context, there is a growing demand from

food companies for quicker testing to release finished goods

more quickly and thus reduce inventories. LFA technology has

come up with many advantages like reliability and short assay

times and allows for reproducible toxin tests and detection

of foodborne pathogens in every segment of the food

production industry.

Veterinary DiagnosisLateral Flow Assays are widely used within the animal health

industry across both household pets and livestock markets

for a variety of medical conditions e.g. equine pregnancy,

bovine pregnancy, fertility and infectious disease testing. This

technology, with high sensitivity and specificity, is an essential

tool in identifying pathogens as part of veterinary diagnostics.

Early detection, management and control of diseases facilitate

improvements in the well-being of animals and increase the

understanding of the impact of animal health on the food

chain and human health.

Environmental Safety & Water TestingAs potential contamination can be of major concern for

public health, the environmental testing market is driven by

increasing regulations to protect the environment with an

active participation of regulatory agencies and governments.

In this context, there is an increasing need for cost- and time-

effective technics performed primarily for spot checks. LFA are

one of the emergent and popularly used rapid technologies

developed for detecting diverse kinds of analytes including

heavy metals, organic compounds contaminating enzymes in

manufacturing plants as well as Legionella in air conditioning

and water systems.

Ahlstrom-Munksjö offers a wide range of high quality fiber-based materials for the manufacture of IVD devices. Our sample,

conjugate and absorbent pads designed for Lateral Flow Immuno Assays applications represent a rapid, cost-effective, easy-to-

use and close-to-the-patient solution for achieving reliable and consistent results.

High purity media without contaminate leachingOur clean and monitored production methods reduce the risk of contamination and interferences during the process

Lot-to-lot uniformity for consistent performanceDependable raw material quality, stable production setting and specifications, ensure consistent and reliable product excellence

Wide product rangeOur broad offer of grades provides differentiated options to specifically match your development requests

Long-term supplyThe continuous level and quality of our supplies support your long-term needs

As a key component to a lateral flow

assay, the conjugate release pad must

perform reliably and consistently. Our conjugate

pads have been developed for reproducible and high

level of conjugate release. Their good uniformity leads

to improved coefficient of variability and high performance

consistency between assays. Moreover, our materials exhibit

reinforced mechanical properties for easy reel to reel treatment.

We offer a wide range of fibers composition material to provide

wide compatibility and efficient filtration of samples. Our

sample pads ensure consistent absorbency and good

wicking rate to reach an uniform distribution of the

analyte onto the conjugate pad.

Our CytoSep® plasma separation pads

are designed to quickly separate

diverse volumes of whole

blood without hemolysis to

achieve increased line

sensitivity.

Ahlstrom-Munksjö absorbent pads

offer consistent absorbency for test

reproducibility. Our absorbent pads

made of a mix of cotton and glass

fibers allow quick clearing of the

membrane by absorbing higher

volumes of liquid and access

the read-out in a shorter

time.

Sample Pad

Conjugate Pad

Absorbent Pad

Our improved solutions for global diagnostics

Glass

8950, 8951, 8964

µGlass

121, 141, 142

Cotton

Polyester fibers

601, 319

6613, 6613H, 6614, 6615, ReliaFlowTM

319, 222, 270, 320

Blend

Glass

Cytosep® 1660, 1662, 1663, 1667, 1668 8950, 8951,

8964, 8914, 8917, 8980

440

Cotton Cotton/Glass

Lateral flow assays provide rapid diagnosis for a wide variety of medical conditions.

The growing range of rapid tests offers incredible advantages: tests can be performed by patients in resource-limited settings, the

diagnosis is obtained within minutes, results are highly reliable and the cost is affordable.

We manufacture the fiber-based materials at

our facilities

Our customers assemble the rapid test kits

The test can be performed by patients at home

Test outcome is available after a few minutes

Patients can take any necessary action

Simple and sustainable access to diagnosis

We innovateWe know the importance of efficiency and accuracy when it comes to improving qualitative and quantitative test methods,

this is the reason for which we are committed to continuously improve our offering and develop innovative materials.

We customizeWe try to better meet the requirements of our customers by providing tailored chemical treatment, cutting, converted design

and packaging.

We offer unique expertiseDuring our growth as a global leader in manufacturing high-performance fiber-based materials we developed expertise in

chemical treatment technologies.

High Quality ManagementOur manufacturing sites are ISO certified to ensure consistency

and lot-to-lot reliability are key. Audits of our sites are welcome,

with prior notice.

Continuous InnovationWe aim to provide scientific capabilities and analytical

expertise for enhanced customer benefits. You’re welcome in

our R&D center for new developments and brainstorming.

Production and ConvertingProduction complies with governing bodies that oversee

rigorous labor control and quality. Our converting capabilities

are selected to achieve the best performance.

Technical Customer SupportAhlstrom-Munksjö offers access to an expert technical support

staff. Through various in-house testing we have compiled data

that allows us to recommend comparable competitive grades.

Customized OptionsWe offer specialized products that can be chemically

pretreated, slit and customized in terms of designs, color

coding, bar coding and packaging to better meet your

requirements.

Ahlstrom-Munksjö: make the right choice!We want our customers to be successful and competitive thanks to our products. At Ahlstrom-Munksjö we develop and offer

custom made specialized fiber-based materials and supply our customers with innovative and sustainable solutions.