Challenges with Single- Vendor Technologies
Challenges with SingleVendor Technologies Yuanxin Xu, Ph.D. AAPS NBC Boston May 16, 2016 1
Introduction New technology advancement provides better assay solutions • Improved assay performance ◦ Better sensitivity, specificity, broader dynamic range, assay reproducibility, tolerance to matrix interference, etc.
• Better lab efficiency ◦ Shorter assay time, higher throughput, less sample volume, automation (walk away), etc. ◦ Lower instrument cost and smaller in size
Use of single-vendor new technologies have challenges. The goal of this session is: • Establish better understanding between vendors (MSD, qPCR, and massspec) and users (Pharma/Biotech and CRO) for each other’s challenges
• Have an open discussion on how to manage instrument long term use (Life-cycle management) and replacement 2
Intended discussion topics Challenges when using one of a kind instruments and associated instrument parts, consumables, reagents, and software -Manufacturer tech support -Impact on sample analysis when instrument is down -User cost (time, $, FTE) -Availability of replacement parts, reagent, and consumables -Lack of back-up instrument -Compliance 3
Assay failure… Failures due to “bad assay”, “poorly trained analyst”, “lousy reagent”, specialty plates, serum lot, or instrument? • Confirmation of instrument as the root cause is challenging
Limited technical support or parts back-ordered • User frustration vs. vendor challenges? • Vendor priority (big user vs. small user) when there is limited supply for specialty consumables or instrument parts?
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Single vendor consumables and reagent Specialty plate lot (column, reagent, etc.) variability • New lot is not comparable to the current lot, resulting in assay failures?
• How to best mitigate this issue?
Vendor has limited lot for pre-screen prior to commitment to buy • Risk of buying a non-comparable lot? • Cost?
5
Plan for instrument replacement Time required for instrument replacement in a compliant lab environment? What users can do to help vendor plan the instrument advancement to the next generation?
6
Vendor going out of business or discontinuing tech support of older platforms Demonstrate instrument comparability between old and new • Perform side by side comparability in cross-validation study?
◦ (Assume no capital budget and space limitations) ◦ Validate representative assays for each type (PK, PD, ADA, multiplex) or surrogate assays? ◦ Use “proficiency samples” (or incurred samples) for cross-validation?
• Full or partial assay validation on new instrument only? ◦ Compare new instrument data with historical data? ◦ Re-test subset of samples or all samples? ◦ What if data between new and old are not comparable?
• Impact on historical data?
What criteria to use to demonstrate software comparability between old and new? • • • •
Side by side assessment between old vs. new software? Select representative data set? Compatibility with the operating system (Windows)? LIMS with instrument interface, ELN, etc.? 7
Summary Discussion from this session will be shared on the AAPS website Thank you: • Our vendor panelists • Pharma/Biotech and CRO panelists • Participants, and the audience for an active discussion.
My personal thanks to Alnylam management support This session was supported by AAPS LBABFG
8
Thank You
9
Introduction New technology advancement provides better assay solutions • Improved assay performance ◦ Better sensitivity, specificity, broader dynamic range, assay reproducibility, tolerance to matrix interference, etc.
• Better lab efficiency ◦ Shorter assay time, higher throughput, less sample volume, automation (walk away), etc. ◦ Lower instrument cost and smaller in size
Use of single-vendor new technologies have challenges. The goal of this session is: • Establish better understanding between vendors (MSD, qPCR, and massspec) and users (Pharma/Biotech and CRO) for each other’s challenges
• Have an open discussion on how to manage instrument long term use (Life-cycle management) and replacement 2
Intended discussion topics Challenges when using one of a kind instruments and associated instrument parts, consumables, reagents, and software -Manufacturer tech support -Impact on sample analysis when instrument is down -User cost (time, $, FTE) -Availability of replacement parts, reagent, and consumables -Lack of back-up instrument -Compliance 3
Assay failure… Failures due to “bad assay”, “poorly trained analyst”, “lousy reagent”, specialty plates, serum lot, or instrument? • Confirmation of instrument as the root cause is challenging
Limited technical support or parts back-ordered • User frustration vs. vendor challenges? • Vendor priority (big user vs. small user) when there is limited supply for specialty consumables or instrument parts?
4
Single vendor consumables and reagent Specialty plate lot (column, reagent, etc.) variability • New lot is not comparable to the current lot, resulting in assay failures?
• How to best mitigate this issue?
Vendor has limited lot for pre-screen prior to commitment to buy • Risk of buying a non-comparable lot? • Cost?
5
Plan for instrument replacement Time required for instrument replacement in a compliant lab environment? What users can do to help vendor plan the instrument advancement to the next generation?
6
Vendor going out of business or discontinuing tech support of older platforms Demonstrate instrument comparability between old and new • Perform side by side comparability in cross-validation study?
◦ (Assume no capital budget and space limitations) ◦ Validate representative assays for each type (PK, PD, ADA, multiplex) or surrogate assays? ◦ Use “proficiency samples” (or incurred samples) for cross-validation?
• Full or partial assay validation on new instrument only? ◦ Compare new instrument data with historical data? ◦ Re-test subset of samples or all samples? ◦ What if data between new and old are not comparable?
• Impact on historical data?
What criteria to use to demonstrate software comparability between old and new? • • • •
Side by side assessment between old vs. new software? Select representative data set? Compatibility with the operating system (Windows)? LIMS with instrument interface, ELN, etc.? 7
Summary Discussion from this session will be shared on the AAPS website Thank you: • Our vendor panelists • Pharma/Biotech and CRO panelists • Participants, and the audience for an active discussion.
My personal thanks to Alnylam management support This session was supported by AAPS LBABFG
8
Thank You
9
