From Pilot to Scale: Addressing Laboratory Challenges in IVD and Biopharma Development

October 7, 2026

“Talk to your laboratory early. You don't need to wait until the protocol is finalized or until you're ready to ship samples.”

Early collaboration can help teams identify potential challenges while there is still time to address them—and can create a clearer path from initial testing to larger-scale laboratory programs.

Why can a laboratory project become more complicated than expected?

One of the biggest variables is often the specimen itself.
A requirement for 500 specimens, for example, is very different from a requirement for 500 specimens that must meet specific disease states, positivity criteria, concentration ranges, demographic characteristics, or other parameters while also providing sufficient volume for all required testing.

Once testing begins, additional considerations can emerge, including:

- Reagent availability and stability
- Calibration and quality control requirements
- Instrument throughput and capacity
- Repeat and invalid testing
- Discordant results and comparator testing
- Sample shipping and storage requirements
- Freeze-thaw limitations
- Data and documentation requirements

A requirement that appears minor during protocol development can become much more significant when multiplied across hundreds or thousands of specimens.
This is why laboratory feasibility should be considered alongside scientific objectives from the beginning.

What should happen before the first sample arrives?

When Boca Bio evaluates a new laboratory project, the first question is simple:

What is the client trying to accomplish?

From there, the laboratory team can work backward from the study objective to determine what will be required operationally.

That includes evaluating the number and type of specimens required, available sample volume, platforms and assays, comparator testing, expected timelines, storage and stability requirements, and the data and documentation that must ultimately be delivered.

Planning should also account for what happens when testing does not proceed exactly as expected.
Is sufficient specimen volume available for repeats? How will invalid or discordant results be handled? Are adequate reagents and controls available? Does the testing sequence need to preserve limited sample material for subsequent analysis?

As Boca Bio's Laboratory Director explains:

“Those conversations before the first sample arrives can prevent a lot of problems later.”

Why involve the laboratory earlier in study planning?

Laboratories are sometimes brought into a project after the protocol and many operational decisions have already been established.

Earlier involvement gives the laboratory an opportunity to provide practical input on considerations such as sample volume, aliquoting strategy, storage conditions, freeze-thaw limitations, testing sequence, comparator methods, reagent requirements, instrument capacity, and realistic timelines.

For IVD developers, this can be particularly valuable when a study involves limited specimens, multiple testing platforms, comparator methods, or highly specific specimen requirements.

For biopharma teams, similar considerations can affect biomarker testing, sample management, exploratory analyses, and other laboratory-supported research workflows.

The objective is not simply to identify whether a laboratory can perform a test. It is to determine whether the overall study can be executed efficiently while protecting specimen integrity and generating the required data.

Can a pilot help reduce risk before a larger laboratory project?

For appropriate projects, a pilot can provide an opportunity to test the proposed workflow before committing a larger number of valuable specimens and resources.

Even a relatively small sample set can provide information about sample handling, assay performance, testing workflow, data collection, turnaround expectations, and whether assumptions made during planning translate effectively into the laboratory environment.

As Boca Bio's Laboratory Director puts it:

“It is much easier to make an adjustment after testing 20 or 50 samples than after testing 1,000.”

A pilot may reveal that additional sample volume is required, repeat or invalid rates differ from expectations, a specimen type behaves differently on the assay, or part of the laboratory workflow should be modified.

Finding those issues early creates an opportunity to investigate and adjust the approach before substantially more specimens are committed.
That can be especially important when working with rare, difficult-to-source, or limited-volume specimens.

Why does an integrated specimen and laboratory workflow matter?

When specimen sourcing and laboratory testing are handled independently, a specimen can technically meet the sourcing criteria while still creating challenges downstream.

For example, the laboratory may discover that there is insufficient volume for all required testing, processing was performed differently than expected, freeze-thaw limits have already been reached, storage conditions are not appropriate for the assay, or labeling does not align with the laboratory workflow.

If those issues are discovered only after specimens have been collected and shipped, the options for correcting them may be limited.

Coordinating specimen sourcing, processing, aliquoting, storage, testing, and data can provide greater visibility across the specimen journey.

It can also reduce handoffs between organizations and simplify traceability when unexpected results require investigation.

Understanding how a specimen was collected, processed, stored, and handled can provide important context when laboratory teams investigate unexpected assay behavior, invalid results, or other testing questions.

More than running a test

A laboratory partner's role can extend well beyond placing a specimen on an instrument.

Depending on project requirements, Boca Bio's laboratory team can support areas including study planning, assay validation and verification, comparator and discordant testing, specimen processing and aliquoting, frozen storage, data management, and laboratory documentation.

Experience across multiple laboratory platforms can also support IVD programs requiring different testing methodologies.

For existing clients, consolidating additional laboratory work may make sense when doing so improves the scientific or operational workflow.

For example, when a laboratory is already conducting primary testing and can also support comparator or discordant testing, keeping those activities together can reduce specimen shipments and handoffs while simplifying data reconciliation.

The laboratory already understands the study, the specimens, and the client's documentation and data requirements.

Protecting the study—not simply completing the testing

Laboratory efficiency is important, but speed should not come at the expense of study integrity.

Early testing can occasionally reveal unexpected assay behavior, higher-than-anticipated invalid rates, or other results that warrant investigation.

In those situations, the appropriate response may be to stop, investigate the workflow, review the specimens, communicate with the manufacturer when necessary, or perform comparator testing before continuing.

As Boca Bio's Laboratory Director explains:

“For me, protecting the integrity of the study is more important than simply completing testing as quickly as possible.”

That philosophy is also one of the ideas behind a new initiative from Boca Bio designed to make it easier for organizations to begin, evaluate, and expand their laboratory relationship.

Introducing the Boca Bio Lab Advantage Program

The Boca Bio Lab Advantage Program is designed to give new and existing clients more flexibility when evaluating or expanding their use of Boca Bio's laboratory services.
Rather than requiring every relationship to begin with a large laboratory commitment, the program provides opportunities to start with a pilot, expand into larger projects, explore additional laboratory services, or integrate biospecimen sourcing and laboratory testing.

New Client Advantage

Organizations interested in evaluating Boca Bio's laboratory services can begin with an eligible pilot project and receive a 15% discount on their first pilot, up to $2,500.

If the pilot progresses into a qualifying larger project within 60 days, the discount can extend to the expanded project.

The goal is to give teams an opportunity to experience the laboratory workflow and evaluate the partnership before scaling.

Existing Client Advantage

Existing clients can receive additional value when expanding their laboratory relationship with Boca Bio.

Clients launching a qualifying new laboratory project valued above $100,000 can receive an additional 10% discount, while clients introducing a new laboratory service into their workflow may qualify for a one-time bonus credit.

Biospecimen + Lab Bundle Advantage

For studies requiring both specimens and laboratory services, Boca Bio can integrate the two workflows.
Clients purchasing qualifying biospecimens from Boca Bio's repository or through prospective collection together with laboratory testing or validation work can receive 10% off both eligible components.

Beyond the financial benefit, an integrated model can help align specimen requirements with downstream laboratory needs from the beginning—connecting sourcing, processing, testing, storage, and data within a coordinated workflow.

Start the laboratory conversation earlier

Perhaps the most important takeaway for an IVD or biopharma team planning its next laboratory program is also the simplest:

Talk to the laboratory before everything is finalized.

Share the scientific objective. Discuss the specimens. Review the proposed testing strategy. Identify potential limitations. Determine what happens when results do not behave as expected.

One conversation during planning may uncover an issue that would otherwise become significantly more difficult to address after hundreds of specimens have been sourced or testing has begun.

Whether you're considering a small pilot, planning a large validation program, exploring a new laboratory service, or looking to integrate biospecimen sourcing and testing, Boca Bio's laboratory team can review your project requirements and help determine an appropriate path forward.

Have an upcoming laboratory project? Talk with our laboratory team about your study and learn whether the Boca Bio Lab Advantage Program may apply.

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