Need

The Seeker for this Innocentive Challenge is looking for root causes and mechanisms of reversible post-thaw decrease in calcium concentration in a ready-to-use, liquid, human-serum-based quality control (QC) standard for laboratory testing, and interventions to neutralize this observed decrease in calcium concentration post-thaw.

Clinical labs routinely use quality control (QC) standards to verify the ongoing performance and precision of automated analyzers performing routine laboratory testing. In some samples of a QC standard manufactured by the Seeker, the Seeker noticed a decrease in post-thaw calcium concentration: in a freshly thawed sample, the effective concentration of calcium is lower than the added amount. The decrease, which is batch-to-batch and vial-to-vial dependent, is also reversible with additional mixing of the sample.

The objective of this Challenge is to understand the root cause(s) and mechanisms of this reversible post-thaw decrease in calcium concentration and to design approaches to prevent it from happening.

Prize/IP

The Seeker has allocated a potential total award pool of $40,000 for this Prize Challenge and guarantees making total award payments of at least $15,000, with the best solution(s) having the opportunity to win awards from $2,500 to $15,000. Determination of the best solution(s) is at Seeker's sole discretion.

By taking part in and submitting to this Challenge, there is no assignment of IP rights, but you are granting the Seeker an irrevocable, fully paid-up right and license to use (but not own) your submitted written solution and the ideas contained in the written solution for any purpose, provided that the Seeker (a) pays at least a total of $15,000 in awards (to one Solver or split among multiple Solvers) and (b) selects the award-winning Solver(s) within 45 days from the start of the evaluation period. You are granting Seeker the right and license in this paragraph, whether or not you are selected as an award-winning Solver.

Submissions to this Challenge must be received by 11:59 PM (US Eastern Time) on June 1st, 2026.

Please review the later Participation Guidance section before submitting a proposal.

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Challenge

Background

Clinical labs rely on automated analyzers to perform routine laboratory testing. To function properly and assess precision, the analyzers need to be routinely tested against a proper quality control (QC) standard, such as a commercially available product.

One of our products is a QC standard for laboratory testing. The standard is a ready-to-use, liquid, human-serum-based formulation containing a precise, known amount of various blood components, called analytes.

The product is composed primarily of human serum, with electrolytes (Ca, Mg, Zn, carbonates, phosphates, etc.), metabolites, proteins, enzymes, and lipids added at concentrations to approximate patient specimens across a range of analytes. The formulation includes stabilizers, preservatives, buffering agents, and surfactants to support analyte stability and microbiological integrity.

For more details, see the table below.

The QC samples are kept frozen at -20 °C in amber glass vials filled at varying volumes (< 10mL) (>10,000 vials per batch). To prevent the formation of ice crystals, cryoprotectants are added to the formulation.

Before use, the QC samples are removed from frozen storage and allowed to thaw at ambient temperature for <60 min.

We have noticed that in some of the samples, after being stored at -20°C for 6 months or more, a reversible post-thaw decrease in calcium concentration takes place. That means that in a freshly thawed sample, the effective concentration of calcium is 4% or more lower than the expected amount.

The decrease in calcium concentration is batch-to-batch and, even more surprisingly, vial-to-vial dependent.

This post-thaw decrease doesn’t happen in the samples stored at -20°C for less than 6 months.

The decrease in calcium concentration is also reversible with additional mixing of the sample or equilibration (increasing the thaw time to 24-48 hrs at 2-8°C).

The Challenge

The goal of this Challenge is to understand the root cause(s) of reversible post-thaw decrease in calcium concentration and to design approaches to prevent it from happening.

We expect submissions to this Challenge to be composed of two parts.

In Part 1, the Solvers should thoroughly investigate the mechanisms (root causes) of reversible post-thaw decrease in calcium concentration.

Our preliminary studies indicate that the decrease in calcium recovery may be due to calcium salts. The following factors have not been excluded for potential explanation: protein binding, effects of surfactants, pH/ionic-strength shifts, micro-precipitation/phase separation, and others.

The proposed mechanism(s) should be able to account for:

• Affected samples showing a decrease in calcium concentration after being stored at -20°C for 6 months or more
• Reversibility with additional mixing/equilibration
• Batch-to-batch and vial-to-vial variability

In addition – and this is very important! – the proposed mechanism(s) should be accompanied by 2-3 experimental tests to prove or disprove the mechanism(s) (what to measure and predicted outcomes if the hypothesis is true/false).

In Part 2, the Solvers are expected to propose intervention(s) that would mitigate or neutralize the mechanism(s) they outlined in Part 1. By mitigation, we mean the decrease of calcium concentration by less than 4%.

The proposed intervention(s) must meet the following criteria:

• Mitigate or eliminate observed decrease in calcium concentration, that is, to reduce the decrease in calcium concentration to less than 4%
• Avoid changes to routine laboratory use
• Include risk assessment of potential effects of the proposed intervention on the following factors:
  • pH/ionic-strength shifts
  • Metal balance
  • Osmolality

Important! The use of QC standards is regulated by ISO 13485, so any successful intervention (in Part 2) should comply with ISO 13485. In practice, that means that the intervention must be formulation-neutral, that is, not changing, in any meaningful way, the chemical composition of the formulation. It also means, no deviations from the standard protocol of preparing and using the samples, except for the sample initial freezing and degassing and precise protocol of sample thawing.

Equally important, the proposed interventions must comply with REACH and PFAS regulations.

Solution Requirements

We’re open to any innovative solution to the reversible post-thaw decrease in calcium concentration problem as long as the proposed submissions meet the following Solution Requirements:

1. The proposed solution is arranged in two parts:
   1. Part 1 proposes the mechanisms (root causes) of the decrease in calcium concentration post-thaw. The mechanisms should take into account the most salient features of the phenomenon, such as reversibility with mixing/equilibration and batch-to-batch and vial-to-vial variability. Part 1 should also articulate 2-3 experimental tests to prove or disprove the proposed mechanisms (what to measure and predicted outcomes if the hypothesis is true/false).
   2. Part 2 proposes intervention(s) that would mitigate or neutralize the mechanism(s) outlined in Part 1. This part should also include a detailed intervention protocol.
2. The proposed intervention(s) should meet the following criteria:
   1. Mitigate or eliminate observed decrease in calcium concentration, that is, to reduce the decrease in calcium concentration to less than 4%
   2. Avoid changes to routine laboratory use
   3. Include risk assessment of potential effects of the proposed intervention on the following factors:
      1. pH/ionic-strength shifts
      2. Metal balance
      3. Osmolality

The proposed intervention should fully comply with ISO 13485, as well as REACH and PFAS regulations. In practice, that means that the proposed intervention should be formulation-neutral and not to deviate from the standard protocol of preparing and using QC samples.

Important! We are not interested in solutions that provide no more than a literature review on the topic. The proposed explanation must be thorough, data-driven, and solidly supported by the available literature. The proposed interventions must be practical, that is, provide us with an actionable roadmap to speedy implementation. A discussion of potential trade-offs and perceived implementation risks is a must.

Solutions with Technology Readiness Levels (TRLs) 3-5 are invited.

This Prize Challenge has the following features:

1. There is no assignment of IP rights with this Challenge.
2. The Seeker has allocated a potential total award pool of $40,000 and guarantees making total award payments of at least $15,000.
3. Although you are not assigning IP rights, by taking part in and submitting, you are granting the Seeker an irrevocable, fully paid-up right and license to use (but not own) your submitted written information and the ideas contained in the written information for any purpose, provided that the Seeker (a) pays at least a total of $15,000 in awards (to one Solver or split among multiple Solvers) and (b) selects the award-winning Solver(s) within 45 days from the start of the evaluation period. To reiterate, you are granting Seeker the right and license in this paragraph whether or not you are selected as an award-winning Solver.
4. The best solution(s) have the opportunity to win awards from $2,500 to $15,000. Determination of the best solution(s) is at Seeker’s sole discretion.
5. The Challenge requires a written solution to be submitted, and Awards will be based on the theoretical evaluation of your proposal by the Seeker.
6. The Seeker may issue “Honourable Mention” recognitions for notable submissions that are not selected for monetary awards.
7. The Seeker may wish to partner with the Solver at the conclusion of the Challenge. Please indicate your interest in potentially partnering.

Your Submission

Please login and register your interest, to complete the submission form.

In order to be considered, your completion of the Solution Overview, Feasibility and Risks sections must include your responses to Solution Requirements 1 and 2; the explanation must be thorough, data-driven, and solidly supported by literature; the proposed interventions must be practical with an actionable roadmap to speedy implementation. A discussion of potential trade-offs and perceived implementation risks is a must.

The submitted proposals must be written in English and can include:

1. Participation type – you will first be asked to inform us how you are participating in this challenge, as a Solver (Individual) or Solver (Organization).
2. Solution Level - the Technology Readiness Level (TRL) of your solution.
3. Problem & Opportunity - highlight the innovation in your approach to the Problem, its point of difference, and the specific advantages/benefits this brings (up to 500 words).
4. Solution Overview - detail the features of your solution and how they address the SOLUTION REQUIREMENTS (500 words, there is space to add more in the summary field, and attach supporting data, diagrams, etc.).
5. Solution Feasibility – Supporting Information and Rationale, such as references and precedents, that will help the Seeker evaluate and validate the feasibility of the solution (up to 500 words).
6. Experience - Direct or adjacent expertise and real-world use cases you or your organization have in relation to the challenge need (up to 500 words).
7. Partnering - there may be an opportunity to partner at the conclusion of this Challenge. Please indicate if potential partnering is of interest to you.
8. Solution Risks - any risks you see with your solution and how you would plan for this (up to 500 words).
9. Timeline, capability, and costs - describe what you think is required to deliver the solution, estimated time and cost (up to 500 words).
10. Online References - provide links to any publications, articles or press releases of relevance (up to 500 words).

Participation Guidance

1. Submission Close Date: Submissions to this Challenge must be received by 11:59 PM (US Eastern Time) on June 1st, 2026.
2. Late submissions: Late submissions will not be considered.
3. Multiple submissions, 3 Maximum: In case of multiple submissions by the same Solver, only 3 submissions – the final 3 submitted – will be considered. Any other submissions will be deleted prior to evaluation.
4. Submission form and attachments: Your submission will be evaluated by the evaluation team first reviewing the information and content you have submitted at the submission form, with attachments used as additional context to your form submission. Submissions relying solely on attachments will receive less attention from the evaluation team.
5. Evaluation notification steps: After the Challenge submission close date, the Seeker will review and select the winning ideas/solutions according to the timeline in the Challenge header. Everyone who submits a proposal will be notified about the status of their submissions.
6. Use of AI: Please note that any submissions produced solely with generative AI are not of interest.
7. Learn more: Find out more about participation in Innocentive Challenges.