Every diagnostic development project is unique, requiring solutions specifically designed to meet precise scientific and operational goals. However, streamlining a project can be challenging, especially in the rapidly changing field of molecular and immunoassay development.
This eBook showcases real-world examples of how personalized strategies help accelerate diagnostic development while maintaining quality and reliability at every stage.
Download this eBook to discover:
- How tailored diagnostic solutions can streamline complex development projects
- Case studies demonstrating successful collaborative approaches
- How personalized strategies can meet unique technical and scalability demands
Powering
diagnostics
at scale
Large custom projects
eBook
Introduction
Each of your molecular or immunoassay development projects is unique. So, you
need solutions tailored to your specific needs. Cytiva has a proven track record
of delivering innovative diagnostic design and development services. This case
study eBook highlights large, real-world examples of successful custom service
collaborations with diverse clients.
From assay design and optimization to high-throughput production and validation,
our comprehensive capabilities and technologies can help you overcome challenges
and deliver impactful outcomes. Whether you are a scientist or business leader
working on or looking to accelerate your diagnostic assay and kit development,
you can depend on us.
Company size
Indicative of
the number of
employees
Indicative of the
number of units
produced
Indicative of
the time from
project start to
completion
Indicative of
the type of
customization
provided
Project size Time frame Customization
type
Scope and scale of the project
2
Download our small-mid scale projects eBook
Read our
customer
success
stories
Plug and play lyo-stable
beads for disease assays
Project story
• The customer has a point-of-care device that is loaded with cartridges.
• Each cartridge contains all the molecules needed to perform a particular
assay. For end-user convenience, the cartridges are designed to be stored
at room temperature.
• They asked Cytiva to provide lyo-stabilization services to manufacture
the beads that go in the cartridges.
• Our lyo-stable technology allows molecules to be freeze dried without
harming their functionality.
• Soon after the project launched, the COVID-19 pandemic created a
sudden need for shortened timelines and increased production.
• The Cytiva team worked closely with the customer to optimize processes
to meet the pace and manufacturing demands. The customer tried using lyophilization to make room-temperature
stable beads for their assay device. But they couldn’t produce the
beads with high enough quality. So, they turned to Cytiva.
Our working relationship with them was especially good because
we had a local specialist who spoke their native language.
Martina Kahl, Diagnostics Account Manager
Speak to Martina to learn more: martina.kahl@cytiva.com
Company size Project size Time frame Customization type
Medium Large 4 months Service
3
Learn more about Lyophilization
Turning your
idea in to reality
Project story
• The customer had an idea to develop a multiplex lateral flow test that
would test for multiple respiratory tests on one strip.
• The customer provided the reagents to use in the test, and asked Cytiva
to design and build the product itself.
• Cytiva worked closely with the customer with frequent calls to make
sure that the customer was always informed and satisfied.
• Cytiva produced prototypes for the customer’s internal testing and
approval.
• The final product worked, met all the customer’s criteria, and was
delivered within the customer’s timeframe.
Company size Project size Time frame Customization type
Small Large 1 year Product
We met the customer informally at a conference in late 2021
and started working with them in early 2022. We had a close
collaboration and spoke to the customer every week. We even
shared our working documents with them.
Klaus Hochleitner, Global Product Specialist, Diagnostics
Speak to Klaus to learn more: klaus.hochleitner@cytiva.com
4
Learn more about our immunoassay development services
Magnetic beads
for a massive test
Project story
• The customer was developing a blood test that would screen for 50
different, but related, diseases.
• The customer chose to work with Cytiva because of our experience,
flexibility, and wide range of customization options.
• The customer asked for custom magnetic beads packaged for them in a
specific buffer.
• Cytiva produced several iterations to optimize the product.
• Our ability to scale up and provide security of supply made the
customer feel comfortable working with us.
• The customer is asking for a new version of the magnetic beads and is
discussing working with Cytiva on other parts of the project.
Company size Project size Time frame Customization type
Large Large 4 years,
ongoing Product
We dedicated a small team to this customer, but we made sure
that everyone on the team was very knowledgeable, nimble,
and responsive to the needs of the project. They visited our
manufacturing facilities and were impressed at how regimented
and well-documented all their processes were.
Max Hogan, Diagnostics Account Manager
Speak to Max to learn more: max.hogan@cytiva.com
5
Learn more about our magnetic bead conjugation services
Complete, lyo-stable
kits from start to finish
Project story
• The customer has a device that can perform real-time cell analysis. They
needed kits made for the device that their customers could use when they
worked with device.
• Originally, the customer asked Cytiva to make just part of the kit, but once
they learned what we could do, they expanded our role to make the entire kit.
• A key part of Cytiva’s role is making lyophilized beads to go into each kit.
The customer simply tells us what to include, and we make it.
• Cytiva then compiles the complete kit including printing and attaching the
customer’s labels.
• Customer satisfaction was achieved in part because we purchased
equipment specifically for their project and we helped solve their
shipping issues.
• Cytiva and the customer traded visits to one another’s manufacturing
plants to keep up quality and maintain open communication.
This project was large to begin with, but it became even larger over
time. We were originally asked to make five kits. The customer was
so pleased with the first set that they keep asking for new ones.
We’re up to 14 or 15 kits now, and we will continue to keep develop
kits as long as the customer wants.
Steve Nelson, Diagnostics Account Manager
Speak to Steve to learn more: steven.nelson@cytiva.com
Company size Project size Time frame Customization type
Large Large 4 years,
ongoing Product
6
Learn more about our lyophilization services
Company size Project size Time frame Customization type
Large Large 3 years,
ongoing Service
We won this project because we have such great coverage across
different areas of expertise and capabilities. We knew going in that
the project was big, but it turned out to be a lot bigger than we
imagined. We were still able to comfortably manage the size.
Math Davies, Diagnostics Account Manager
Speak to Math to learn more: matthew.davies@cytiva.com
When they said “big,”
they meant it
Project story
• The customer built a new sequencing platform and needed consumable
products to be used with the platform.
• The customer had strict requirements about the qualifications and education
of the people working on the project, and Cytiva met these criteria.
• For the project, Cytiva was asked to lyophilize some reagents and
package them.
• The project is so large that Cytiva built a facility to do the work. We even
purchased our largest freeze dryer for the project.
• The project began in 2020 during the height of the pandemic, so
Cytiva arranged virtual tours of our facilities so that the customer was
comfortable with the progress and quality of work.
• Now, the customer and Cytiva have multiple meetings a week and the
customer has regular on-site tours of the facilities.
• The project is ongoing, and the customer is pleased with our service.
7
Learn more about our contract manufacturing and
kitting services
When we started this project, we thought that it was going to be
small. The customer even thought that it would be short-term.
But the project grew and is still ongoing. Fortunately, we have the
capacity to grow with the customer’s needs.
Math Davies, Diagnostics Account Manager
Speak to Math to learn more: matthew.davies@cytiva.com
A project that doesn’t
end, and that’s great
Project story
• The customer was launching molecular diagnostic tests in
lyophilized format.
• The original request was for Cytiva to lyophilize just a couple of tests,
and the customer thought that would be the end of the project.
• However, the customer was so pleased with what Cytiva provided that
they asked for a few more tests. And then some more.
• The customer is a large company who could make the tests themselves,
but they still chose to work with Cytiva.
• We share working files with the customer, have face-to-face meetings,
trade site visits, and generally have open communication with them.
We also perform regular audits.
• The project is still ongoing. The customer’s product is doing well
commercially, so more tests are expected.
Company size Project size Time frame Customization type
Large Large 4 years,
ongoing Service
8
Learn more about our full range of diagnostic services
More information
Powering
diagnostics
at scale
Small- to mid-size custom projects
eBook
9
Checklist: 10 essentials for choosing a collaborator for diagnostic assay Download our small-mid scale projects eBook
cytiva.com
Cytiva and the Drop logo are trademarks of Life Sciences IP Holdings Corp. or an affiliate doing
business as Cytiva.
© 2023 Cytiva
For local office contact information, visit cytiva.com/contact
CY36360-07Jul23-EB