Sample Storage Quality & Identification Tracking Trends 2016
Published By : HTStec Ltd Published Date : 2016-11-03 Category : Medical Devices Sub Category : Medical Equipment No. of Pages : 52

This market report summarizes the results of HTStec's industry-wide global web-based benchmarking survey on the emerging requirements for identification tracking and maintaining the quality of stored samples.

The survey covered both biospecimens and drug compounds stored under frozen and/or ambient conditions.

The survey was carried out in October 2016.

The survey was initiated by HTStec on behalf of a client who plans to introduce a new technology that provides both sample identification and quality tracking.

The objectives of the survey were to understand current methods used for identification (ID) tracking of stored samples, the importance of sample quality and of approaches used to maintain quality, and to establish potential interest in a new sample ID and quality tracking technology.

The survey looked at the following aspects of sample storage quality & ID tracking trends as practiced today (2016) and in a few cases as predicted for the future (2018):

  • groupings where involvement with stored samples predominantly reside; main applications or intended uses of stored samples; how samples are tracked today;
  • how the quality of stored samples is verified; level of satisfaction with a list of quality and chain of custody tracking technologies; types of consumables used for sample storage;
  • types of materials used for sample/specimen containers;
  • importance of environmental sustainability factors when purchasing storage consumables;
  • number of samples stored in respondent's sample inventory;
  • main obstacles that prevent maximizing the use of stored samples today;
  • relative rating of obstacles that may limit the use of stored samples;
  • average cost to replace a poor quality sample;
  • what is most damaging to the expected use of stored samples;
  • how many times samples are exposed to a significant temperature change per day;
  • current use protocol for stored samples;
  • value placed on a continuous audit trail of sample ID and the temperature exposure;
  • whether stored samples are subject to standardized SOPs prior to storage;
  • aspects of sample deposition and the storage process that are most critical to success;
  • what storage temperatures apply to respondent's stored samples;
  • features most wanted in any new sample ID and quality tracking technology;
  • perceived advantages of using a new ID and quality tracking system;
  • acceptable price for a sample ID and quality tracking device;
  • respondents who would consider using a new ID and quality tracking system fitted to their consumables;
  • number of tagged standard 2mL cryovials that might be purchased per year;
  • likelihood of investing in any new sample storage consumable technologies that improve and or extend the life of stored samples;
  • main reasons for not using an ID and quality tracking system;
  • sample storage consumables budget;
  • preferred vendors of the majority of sample storage consumables purchased;
  • possible added value application opportunities for a new ID and quality tracking system;
  • feedback on the usefulness of a new ID and quality tracking system;
  • any unmet needs in the current products that support sample storage ID tracking and quality validation;
  • and respondents who are willing to be contacted to discuss their sample storage tracking and quality requirements further.

The main questionnaire consisted of 30 mainly multi-choice questions. In addition, there were 7 questions related solely to administration/survey demographics.

The survey collected 51 validated responses, of these 85% provided comprehensive input.

Survey responses were geographically split: 47% North America; 27% Europe; 14% Asia (excluding Japan & China); 6% Rest of World; 4% China; and 2% Japan.

Respondents represented 14 University/Research Institute/Not-for-Profit; 10 Pharmaceuticals; 9 Biobank/ Biorepository; 8 Biotech; 3 Hospital/Clinic/Medical School; 2% Diagnostics; 2 CRO; 1 Agrochemical; 1 Government/Military/Defense; and 1 Commercial Organisation (Vendor).

Most survey respondents had a senior job role or position which was in descending order: 9 directors; 7 research scientists; 7 cryo stores/laboratory managers; 7 senior scientists/researchers; 3 post-docs; 3 project managers; 3 principal investigators; 3 other job roles; 2 section/group leaders; 2 professors/ assistant professors; 2 department heads; 2 presidents/VP's; and 1 buyer or procurement officer.

Survey results were expressed as an average of all survey respondents. In addition, where appropriate the data was reanalyzed after sub-division into the following 6 survey groups: 1) Industry; 2) Academia; 3) End-Users; 4) Management; 5) Biospecimen Focus; and 6) Compound Focus.

The majority of respondents were currently collecting, storing and utilizing stored samples.

The majority were involved in storing biological samples, biologics, biospecimens, cells or tissues.

The majority of respondents were sample management or staff responsible for funding, procurement, operation and/or the logistics around the supply of biospecimens or compound samples.

The main application or intended use of stored samples was biomarker research or drug discovery.

Human readable printed labels were still used by the majority of respondents to track samples today.

With respect to verifying the quality of stored samples most either performed an incoming quality audit prior to sample storage or performed a quality audit when the sample is requested from the store.

The level of satisfaction with quality and chain of custody tracking technologies was rated highest (most satisfied) with scanning of 2D and linear 1D barcodes.

The most used type of consumable for sample storage today (2016) was vials or tubes.

The main type of materials used in sample/specimen storage was polypropylene storage tubes.

Environmentally sustainable factors were viewed somewhat important when purchasing consumables as long as the cost remains consistent with comparable products.

A median of 10K-100K samples (including replicates) were stored in respondent's sample inventory.

Feedback on the main obstacles that prevent respondents maximizing the use of their stored samples today were documented.

Freeze/thaw cycles causing a sacrifice in sample quality was rated the main obstacle that most limits use of stored samples.

The median average estimated cost to replace a poor quality sample was $51-$100.

The majority reported that poor sample quality causing erroneous downstream analytical results was the most damaging problem to their expected use of stored samples.

Stored samples were exposed to a median of 1 (one) significant temperature change per day.

The current use protocol most adopted for stored samples was single use aliquots in vials, tubes or straws with any remaining sample discarded.

Most placed moderate value (to flag samples exposed to temperature variation) on a continuous audit trail of sample ID and the temperature excursions a sample has been exposed to during its life cycle.

Most of respondent's stored samples were either prepared off-site or on-site according to strict SOPs to minimize pre-analytical variables.

Strict adherence to protocol was ranked the aspect of the sample deposition and sample storage process most critical to success.

The storage temperature range most applied to respondent's stored samples was -20°C to -80°C.

Operates across the widest possible storage temperature range was rated the most valuable feature wanted in any new sample ID and quality tracking technology.

Survey respondents were introduced to and asked for provide feedback on chip-based micro-electro-mechanical system (MEMS) ID and quality tracking system attached to sample storage consumables that offers instantaneous recognition of sample ID and sensing of other quality parameters.

Improves end-user confidence in samples was rated as the most important advantage of using a MEMS ID and quality tracking system.

The median acceptable price for a MEMS ID and quality tracking device was $0.10-$0.50 per chip.

The majority would consider using a MEMS ID and quality tracking device if the price was reasonable.

A median of 1K-5K MEMS chips fitted to 2mL cryovials might be purchased per year.

The median likelihood of investing in any new sample storage consumable technologies over the coming years was possible (26-50%).

The main reason for not using a MEMS ID and quality tracking device fitted to storage consumables was if it added significant extra operational cost.

The median current budget available today to purchase sample storage consumables was $10K-$25K.

The most preferred vendors of sample storage consumables were Thermo Scientific and Corning.

To capture potential damage incurred to biobanking samples due to multiple freeze/thaw cycles was rated the most value adding application of a MEMS ID and quality tracking device.

A bottom up model developed to estimate the market potential of a MEMS ID and quality tracking device fitted to 2mL cryovials valued the market at around $40million per year.

Some feedback on the potential usefulness of the MEMS ID and quality tracking device was documented.

Some feedback on the unmet needs or gaps in the current products that support sample storage tracking ID and their associated quality validation protocols was documented.

22 All Respondents were willing to be contacted to discuss their sample storage tracking and quality requirement requirements further.

The full report provides the data, details of the breakdown of the responses to each question, its segmentation and estimates for the future (2018). It also highlights some interesting differences between the survey groups.

  • Executive Summary
  • Table Of Contents
  • Survey Methodology
  • Respondent's Organisation & Response To Survey
  • Respondent's Geographic Origin.
  • Respondent's Company Or Organisational Origin
  • Respondent's Job Role
  • Respondents Currently Collecting, Storing And Utilizing Biospecimens, Biologics & Compound Samples
  • Grouping That Best Describes Respondent's Involvement In Stored Samples (1)
  • Grouping That Best Describes Respondent's Involvement In Stored Samples (2)
  • Main Applications Or Intended Uses Of Stored Samples.
  • How Respondents Track Their Samples Today
  • How Respondents Verify The Quality Of Their Stored Samples
  • Level Of Satisfaction With Quality & Chain Of Custody Tracking Technologies
  • Summary Of Survey Findings (1)
  • Types Of Consumables Used For Sample Storage
  • Types Of Materials Used In Sample/Specimen Container
  • Importance Of Environmental Sustainability Factors When Purchasing Consumables
  • Total Number Of Samples In Respondents Sample Inventory
  • Main Obstacles That Prevent Respondent's Maximizing Use Of Their Stored Samples Today
  • Extent To Which Obstacles Limit Respondent's Use Of Stored Samples
  • Average Cost To Respondents To Replace A Poor Quality Sample
  • Problem Most Damaging To Respondents Expected Use Of Stored Samples
  • Number Of Times Samples Are Exposed To A Significant Temperature Change Per Day
  • Current Use Protocol For Stored Samples Adopted In Respondent's Facility
  • Value Placed On A Continuous Audit Trail Of Sample ID & Temperature Exposed To Over The
  • Sample Life Cycle
  • Whether Stored Samples Were Subject To Standardized SOPs Prior To Storage
  • Aspects Of The Sample Deposition & Storage Process Most Critical To Respondents Group's Success
  • Storage Temperatures That Apply To Stored Samples In Respondent's Organisation
  • Most Valuable Features Wanted In Any New Sample ID & Quality Tracking Technology
  • MEMS Sample Identification & Quality Tracking System
  • Most Important Advantages Of Using A MEMS Sample ID & Quality Tracking System
  • Summary Of Survey Findings (2)
  • Acceptable Price For A Sample ID And Quality Tracking Device
  • Respondents Who Would Consider Using A MEMS Sample ID & Quality Tracking System
  • Number Of MEMS Fitted To A Standard 2mL Cryovial That Might be Purchased Per Year
  • Likelihood Of Investing In Any New Sample Storage Consumable Technologies
  • Main Reason Would Not Use A MEMS Sample ID & Quality Tracking Device
  • Budget Available To Purchase Sample Storage Consumables
  • Preferred Vendors Of Sample Storage Consumables (1)
  • Preferred Vendors Of Sample Storage Consumables (2)
  • Likely Future Change In Vendor Preference For Sample Storage Consumables
  • Possible Added Value Of MEMS In Applications In Respondent's Organisation
  • Market Potential For A MEMS Sample ID & Quality Tracking Device
  • Comments On The Usefulness Of MEMS Sample ID And Tracking System In Improving Sample Quality
  • Awareness Of Any Unmet Needs In Sample Storage Tracking ID & Quality Validation
  • Interest In Being Contacted To Discuss Sample Storage Tracking & Quality Requirements Further
  • Summary Of Survey Findings (3)
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