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unchained labs Stunner
說明
STUNNER -  2μL, 全波長吸收光譜 & 動態光散射粒徑分析


 


生物製劑定量和質量測量的完美組合


Stunner是兩種身分。它是唯一一個同時可從同一樣品中測量UV/Vis 濃度和動態光散射 (DLS) 大小的系統。通過測量濃度、水合體積(hydrodynamic size)、多分散度和檢測聚合物來測量蛋白質品質。您還可以測量樣品的膠體穩定性(colloidal stability) 或設計自己的自定義應用。


2μL的樣品可以得到什麼資訊?


 STUNNER具有偵測全波長光譜吸收、波長拆解(Unmix)與動態光散射粒徑分析 (DLS) 之功能,每個樣品只需要2μL與約30秒即可獲得蛋白質、病毒顆粒或奈米粒子的濃度、組成、與顆粒大小分布。Unmix 模式可區分實際樣品與不純物之濃度 (如溶劑殘留),並回推成真實的濃度。


粒徑分布可以提供什麼資訊?


有功能性的蛋白質是孤獨的!當蛋白質產生聚集,其親和力與 單位有效濃度便開始下降,最重要的是免疫源性會增加,若注 射進生物體內,產生不良反應的機會便大幅增加。STUNNER內建 B22( particle interaction parameter )與KD測量功能,可以快速簡單地找出不同Buffer條件、儲存狀況與方法、處理後的蛋白質聚集狀況與趨勢


還可以用在基因治療!?


STUNNER 有專為 AAV (Adeno-Associated Virus)測量設計的模式,可定量不同血清型 AAV Titer、Empty Capsid Ratio 與聚集的情形。STUNNER為你的AAV品質把關


法規? 確校? 沒問題


STUNNER 符合USP & Ph. Eur 對於吸收光譜方法學的規範,並提供 NIST 標準品、IOQ文件與支援21 CFR Part11規範的軟 體。Unchained labs的產品已被廣大生物製劑廠採用。


特點


2 µL 樣品體積

微流道樣品槽,沒有樣品蒸發與清潔的困擾

96個樣品,僅需10分鐘測量

SBS 盤式格式

認證表準品 20 – 225 OD @ 280nm

Performance Verification Plate,符合USP & Ph. Eur. UV/Vis 要求

GLP and 21 CFR Part 11

Unmix APP 獨特光譜解析功能,分離 dsDNA, RNA, EDTA與濁度


輸出參數


AAV capsid titer

AAV empty/full ratio

LNP total RNA quant

Aggregation

Concentration

Sizing & polydispersity

B22 & kD


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Description
STUNNER -  2μL, DLS and Full Spectrum Absobance 

 

Combine and conquer

Stunner is the only system that pulls together UV/Vis concentration, Dynamic Light Scattering (DLS) and Static Light Scattering (SLS) data from the same 2 μL sample. Dig in to your AAV to get the total capsid titer and empty/full ratio, or rack up RNA concentration and size data on RNA-LNPs all at once. Nail down your protein quality by knocking concentration, hydrodynamic size, polydispersity, and detection of aggregates off your list in one shot. Without skipping a beat, you’ll know if your AAV, LNP or protein is good to go.

Teeny sample, tons of info

Just load 2 μL of sample in a Stunner plate — don’t bother with sample prep or dilution. Each microfluidic circuit has two fixed pathlengths built into it to cover a wide dynamic range of 0.03-275 OD. If you’re dealing with a full plate, get 96 concentration measurements in 10 minutes — add on DLS sizing and have both done in an hour. For even heavier workflows, hook it up to your favorite robot to add more oomph.

Look your AAV up and down

Drop in your AAV and before you can blink, DLS & SLS figure out how many intact capsids you have or if a bunch of aggregates are screwing things up. See empty/full ratio, total protein and total ssDNA in about a minute with UV/Vis. Don’t worry about extinction coefficients or overlapping spectra – Stunner does all the math for you.

Know your AAV inside out

Get to the numbers you actually want – titers. Stunner bridges DLS and UV/Vis data to tally up how many full and empty capsids are present, and how much extra protein and DNA is left over. Take your cleaned up AAV and sneak a peek down to 1012 vg/mL. In just one assay, Stunner’s dye-free, label-free, standard-free, hassle-free workflow tells the whole titer story.

Titer for any serotype

Every AAV is different, but Stunner figures them all out. Pick a preloaded serotype or feed in the specs for your virus and get answers in seconds. Now you can check capsid titers and empty/full ratio as often as you want.

Aggregates ruin everything

Globs of AAV can stand between you and high-quality data for pretty much every assay. DLS checks if your AAV is monodisperse so the rest of your process doesn’t get tripped up by aggregates.

See through the fog

Cloudy solutions of LNPs hang up other techniques but Stunner’s short pathlengths teamed with DLS and UV/Vis get you the answers you need. Cut through all that turbidity with Unmix and check out just the absorbance signal from RNA without any dyes, reagents or complicated workflow.

Slam through tons of LNP sizing

Stunner’s DLS gives you the high-throughput power to round up size and size distribution data on 96 LNP samples in less than 1 hour. Walk away from one-by-one DLS that requires tons of sample and hefty hands-on time. Beef up your sizing statistics with as many replicates as you want and minimize your time at the bench.

Get the skinny on proteins

Stunner pulls rank on other systems because it’s way, way more than just DLS. It lets you get a grip on what storage, agitation or a change to your process or formulation does to your protein. See if there’s any aggregation, measure the hydrodynamic size, grab polydispersity when you need to check uniformity, and get the exact concentration while you’re at it

Max out your biologic

Stunner is the only system out there that can measure biologics at high-throughput and high concentration. It’s got dynamic range that covers from 0.02 mg/mL to 200 mg/mL (mAb), so run any protein without ever having to dilute again. Stop the madness of running just one protein at a time — and cleaning up afterwards.

Ridiculously good data

Get spot-on precision within 1% and accuracy within 2%. Using two fixed pathlengths, Stunner gets you jaw-dropping data at both low and high protein concentrations and nails the expected concentrations every time. With the smallest sample size, the highest throughput and crazy accurate results, Stunner is hands down the best tool out there for protein quantification.

Double down with B22 and kD

On the fly data tells you if your sample’s in good shape, or if aggregation is in the cards. Because the concentration of each sample in the series is measured in real time with DLS, you get the most accurate values without breaking a sweat.

Brew your own

Pin down what else is going on with your sample, or just check out its other characteristics. Pick a few wavelengths, a background subtraction method, and create your favorite equation. Stunner’s Homebrew tool is wide open, so you can create apps just the way you like them.

Accuracy you can show off

Stunner has shocking accuracy and wants to prove it. Using the Fundamentals tryptophan standards, the accuracy, precision and linearity of the instrument can be proven at any time – at the protein-relevant 280 nm wavelength and OD range of 20-225. Be confident about every sample with data that leaves no room for doubt.

Downstream ready

Smash through the USP & Ph. Eur. UV/Vis requirements for absorbance accuracy, precision, linearity, wavelength accuracy, stray light and resolution with performance verification measurements of independently certified NIST standards. Stunner is ready when you are to get validated and make the move into QC.

Put it on lockdown

GLP labs don’t sweat it. Stunner’s software hooks labs up with 21 CFR Part 11 compliant features. We’re talking password protection, electronic signatures, full audit trail — the whole package.
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