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Amerikanska National Institute of Standards and Technology (NIST)

har sammanställt de hearings man har genomfört med utvalda Reg Med aktörer i syfte att godkänna standards för "tillverkning" av Reg Med produkter. Ett kompendium på 71 sidor som nu släppts. 
I kompendiet har NIST tagit till sig argument för QPI,framförda av Kersti Alm.

4.4.3. Non-invasive Quantitative Live Cell Imaging 
 Dr. Kersti Alm, Phase Holographic Imaging 

Quantitative phase imaging (QPI) is a technique that allows for label-free and minimally invasive cell phenotypic measurements. 

Dr. Alm discussed how holographic imaging, a form of QPI, can be used to monitor cell health, movement, morphology, viability, and behavior in real-time. 
She argued that QPI is becoming a widely accepted method for cell analysis [8]. 
She also demonstrated their HoloMonitor system, which produces holograms that contain information about cell thickness in each pixel of the image. 
These holograms can be reconstructed to display the sample topography in 3D. 
Various morphological parameters can be extracted from the images. 
The time-lapse imaging does not damage the cells during data acquisition. 
The technology has numerous applications including cell tracking, kinetic cell proliferation, cytotoxicity, and wound healing. 
According to Dr. Alm, QPI techniques have gained recognition as viable approaches for cell quality analysis.

Hela kompendiet hittas på nedanstående länk

NIST Special Publication 1500 NIST SP 1500-23 

Measurement Needs for Biofabrication of Tissue Engineered Medical Products Workshop Report 

NIST SP 1500-23 
 April 2024 

 Abstract 

 Biofabricated tissue-engineered constructs have the potential to transform personalized medicine. However, characterizing these constructs post-fabrication and throughout preclinical use remains challenging. On December 1, 2022, the National Institute of Standards and Technology (NIST) held a one-day, virtual workshop on measurement needs for biofabricated constructs that contain cells. The workshop focused on metrology for the structure of the constructs, cell viability in the constructs, and functional capacity of the constructs, with the aim of enabling future research directions, standards development, and the adoption of these constructs for clinical use. The workshop convened over 180 participants and represented academia (28%), government (37%), industry (25%) and non-profit (10%) sectors. The attendees focused on discussing and identifying measurement needs for characterizing biofabricated, tissue engineered medical products (TEMPs) for clinical applications. Expertise of participants included tissue engineering (34%), biomaterials (18%), additive manufacturing (16%) and sensors (11%), among others (22%). The cells and tissues being targeted by participants included musculoskeletal (29%), mesenchymal stem cells (14%), cardiac (9%), fat (8%) and endothelial cells (8%), among others (34%). A survey to query participants about which measurements were most in need of improvement yielded the following results: potency (18%), cell viability (14%), structure (13%), pH-O2-metabolites (10%), and mechanical properties (8%), among others (39%). The workshop revealed that the field of biomanufacturing finds itself in a nascent stage characterized by destructive, labor-intensive methods. The unanimous call for non-destructive, accurate viability and functionality characterization highlights a pivotal need for innovation. Simultaneously, there is a mounting demand for standardized testing, manufacturing parameters, and reference materials, coupled with application-specific standards for different cell types and manufacturing processes. The establishment of collaborative consortia is advocated to foster knowledge sharing and effective integration of technologies. The identified challenges in manufacturing consistency underscore the pressing need for repeatable, reproducible, robust measurement techniques, and interdisciplinary collaborations in biomanufacturing. Additionally, the pivotal role of systems capturing diverse measurements, the preference for minimally invasive sensors, and efforts towards miniaturization of clinical technologies for lab use collectively propel the field towards a progressive and multimodal approach for tissue characterization. The unanimous support for the collection, validation, and standardization of reference data, with the proposal of a central data portal, signifies a concerted effort towards enhancing the reliability and accessibility of crucial information in the field. The insight from the workshop documented in this report can help guide future work on the development of measurements and reference materials to facilitate the biofabrication of tissue engineered medical products.

I kompendiet presenteras Kersti Alm enligt följande (sid 37)

NIST har lagt ut Kersti Alms framträdande på sin hemsida.

Non-invasive quantitative live cell imaging by Kersti Alm, Phase Holographic Imaging

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Innebär det här att HoloMonitor fått en amerikansk godkännande stämpel,frågar Bill

Nej,men det är nära nu,svarar Bull