ma-tek - world leader in nano bio analysis the …...

World Leader in Nano Bio Analysis

The Best RD Partner for Your Success

www.bioma-tek.com

Nano Bio material Characterization Service

Bio Material Analysis Technology Inc.

Comprehensive Physicochemical characterizations

Advanced Bio-EM sample preparation and image analysis

Proficient and Adequate Services.

紀弘泰 Hong- Tai Ji：(03) 611-8611 ext. 3285；[email protected] 陳玉菁 Yu-Ching Chen：(03) 611-8611 ext. 3265；[email protected]

閤康生物科技成立於2014年3月21日，秉持閎康母公司『科技產業研發夥伴』的理念，因

應產、學、研各界對於「奈米」與「生物」技術日益精進的分析需求，以專業的團隊、

先進的技術，依循 TR13014 (奈米生物安全技術報告) 的建議，建構完整的物理化學特性

分析服務，並且以各類型的生物樣品製備技術，提供全方位的生物電顯樣品製備與影像

觀察分析服務。

Established on 3/21/2014, Bio Materials Analysis Technology Inc. (Bio Ma-tek) carries the “R&D

partner for high-tech industry” spirit in its sole investor Ma-tek. To address the ever demanding

needs on the physical and chemical characterization of nano materials in biological systems,

Bio Ma-tek rolls out an array of bio-EM sample preparation and image analysis services and a

comprehensive list of analytical services following the recommendations in TR13014.

願景：成為奈米生物樣品製備與分析的領導品牌

Vision: To become a leading brand in nano- bio- sample preparation and analysis

營運模式：專注核心技術、整合內外資源、提供客戶專業、適切的服務

Business model: Focus on core technology, Leverage external resources, Deliver proficient and

adequate services.

定位：奈米生物樣品分析服務的設計師

Positioning: Solution provider for nano- biomaterial characterization and analysis

服務範圍：食品、化妝品、醫材、藥劑、疫苗、生物組織等等各方面的奈米生物樣品；

提供專業適切的樣品製備與分析服務、顧問諮詢、與委案合作。

Service scope: Nano- Biomaterials in Foods, Cosmetics, Medical materials, Drugs, Vaccines,

Biological tissues and etc.; Provide proficient and adequate sample preparation,

analysis, consultation and contract services.

閤康生物科技股份有限公司

•總公司：302 新竹縣竹北市台元街 26-2 號 1 樓

•實驗室：300 新竹市科學工業園區力行一路 1 號 1A4

Tel: +886-3-611-8611

Fax: +886-3-563-0777

www.bioma-tek.com

• Office: 1F, No. 26-2, Tai-Yuen St., Jubei City, Hsinchu County, 302, Taiwan

• Lab: 1A4, No. 1, Li-Hsin Rd. 1, Science-Based Industrial Park, Hsinchu City, 300, Taiwan

Bio Materials Analysis Technology Inc.

Nanomaterial Characterization Service

Liquid Sample TEM

Physicochemical parameters K-kit Conventional

1. Composition

2. Size

3. Shape

4. Size distribution

5. Aggregation/agglomeration state in relevant media

6. Particle concentration

7. Liquid TEM observation

Good Case dependent Not available

K-kit vs. Conventional

Wet

Thin Layer

The loaded liquid sample is sealed and imaged by TEM in the native liquid environment.

A proprietary sample preparation protocol preserves the original morphology and physical state with improved imaging resolution.

Our Technology (K-kit)

Picture shown: Undiluted CMP-slurry directly loaded into K-kit to observe the primary and secondary abrasives by TEM.

US 7,807,979 B2

PCT/US2013/049595

Anal. Chem. 2012, 84: 6312-6316

Specimen kit for observing the original morphology and physical state of nanomaterials in liquid sample by TEM

Characterize Nano-objects, Aggregates, and Agglomerates (NOAAs) in Product’s Final Form or Relevant Media

Definitive: Direct observation in product’s final form or relevant media, minimizing artifacts.

Quantitative: Image-based statistical analysis of aggregation/agglomeration and particle concentration.

Comprehensive: All physicochemical characterization requirements can be addressed.


Proprietary, DO NOT COPY WITHOUT PERMISSON. All Rights Reserved. 凡本著作任何圖片、文字及其他內容，未經本公司同意授權者，均不得擅自重製、仿製


Nano in Products Characterize Nano-objects, Aggregates, and Agglomerates (NOAAs) in Electronics, Cosmetics, Foods, Medical Devices, Drugs and etc…

Reference: 1. US FDA 2012, Guidance for Industry – Safety of Nanomaterials in Cosmetic Products 2. EU/JRC July 2012, Requirements on Measurements for the Implementation of the European Commission Definition of the Term

“Nanomaterials”. 3. ISO/TR13014: 2012, Nanotechnologies -- Guidance on physico-chemical characterization of engineered nanoscale materials for

toxicologic assessment. 4. ICCR 2012, Characterization of Nanomaterials II - Insolubility, Biopersistence and Size Measurement in Complex Media.

For Regulatory, Manufacturing, and R & D Purposes.

Goes with the Emerging Trend

Lotion - TiO2 and ZnO Nanoparticles in Sunscreen

Milk - CaCO3 Nanoparticles in milk

Bio Tissue - Au nanoparticles in blood

Slurry - SiO2 Nanoparticles in CMP Slurry

Electronics Cosmetics

Food Bio-Med

ZnO TiO2

Aggregation/agglomeration Particle concentration




Nano Characterization Comprehensive Nanomaterial Characterization Service for Functionality Study, Safety Assessment, and Final Product Labeling






Bio Ma-tek service, based on recommendations in ISO/TR 13014

Dynamic light scattering Analysis of SEM, TEM or SPM images Size exclusion chromatography

X-ray diffraction (XRD) X-ray photoelectron spectroscopy (XPS) Raman and other molecular spectroscopies Thermogravimetric analysis Auger electron spectroscopy (AES) Electron microscopy Inductively Coupled Plasma Mass Spectrometer (ICP-MS) Inductively Coupled Plasma Optical Emission Spectrometer (ICP-OES)

Analysis of Cryo-SEM, or Cryo-TEM image Centrifugal liquid sedimentation

X-ray diffraction (XRD) X-ray photoelectron spectroscopy (XPS) Auger electron spectroscopy (AES) Scanning auger electron microscopy Secondary ion mass spectroscopy (SIMS) Energy dispersive x-ray spectrometry Electron energy loss spectroscopy (EELS) Roman and other molecular spectroscopies

Analysis shape of SEM, TEM, or SPM images

Methods based on gas or liquid adsorption isotherms

Isoelectric point Electrophoretic light scattering

Electrophoresis Liquid Sample TEM (K-kit) *

Liquid Sample TEM (K-kit) * Inductively Coupled Plasma Mass Spectrometer (ICP-MS)

*Liquid sample TEM (K-kit)

Specimen Kit for observing the original morphology and physical state of nanomaterials in liquid sample by TEM. (US 7,807,979; PCT/US2013/049595)




Nano Characterization



Example – CaCO3 particles as food additives:

Comprehensive physicochemical characterization

Material

Product Size/size distribution of CaCO3 NOAAs in milk

Size/size distribution

0 100 200 300 400 500 6000

10

20

Diameter (nm)

Aggregates/Agglomerates

0

10

20

Part

icle

num

ber

%

Nano-objects

0

10

20 NOAAs

Ingredients and Additives in Final Product




Nano in Cosmetics


International Cooperation on Cosmetic Regulation Report (ICCR) 2012 Characterization of Nanomaterials II – Insolubility, Biopersistence and Size Measurement in Complex Media.

European Union (EU) Cosmetics Regulatory (EC) No. 1223/2009 Mandatory labeling of Nanomaterials as ingredients in Cosmetics (effective 2013/07/11)

Unites States Food and Drug Administration Guidance (US FDA) 2012 Guidance for Industry - Safety of Nanomaterials in Cosmetic Products

Characterize Nano-Objects, Aggregates, and Agglomerates (NOAAs) in Product’s Final Form by TEM








Nano in Cosmetics Characterize Nano-Objects, Aggregates, and Agglomerates (NOAAs) in Product’s Final Form - Lotion, Cream and Powder

Lotion ZnO NOAAs in Sunscreen

TEM images Size/size distribution

Cream TiO2 NOAAs in Sunscreen

Powder NOAAs in Foundation



* Particle 1, 2 & 3 are constituted by nanomaterials.






Nano in Foods


European Food Safety Authority Guidance (ESFA) 2011 Guidance on the Risk Assessment of the Application of Nanoscience and Nanotechnologies in Food and Feed Chain.

European Union (EU) Food Regulatory (EC) No. 1169/2011 Mandatory labeling of Nanomaterials as ingredients in Foods (effective 2014/12/13).

Unites States Food and Drug Administration Guidance (US FDA) 2012 Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes, Including Emerging Technologies, on the Safety and Regulatory Status of Food Ingredients and Food Contact Substances, Including Food Ingredients that are Color Additives.





As Additive In Product

v.s.

Characterize Nanomaterials in Food Additives & Product’s Final Form




Nano in Foods



Example – CaCO3 particles as milk additives:

Comprehensive physicochemical characterization

Material

Product Size/size distribution of CaCO3 NOAAs in milk

Size/size distribution

0 100 200 300 400 500 6000

10

20

Diameter (nm)

Aggregates/Agglomerates

0

10

20

Part

icle

num

ber

%

Nano-objects

0

10

20 NOAAs

*Liquid sample TEM (K-kit) Specimen Kit for observing the original morphology and physical state of nanomaterials

in liquid sample by TEM. (US 7,807,979; PCT/US2013/049595)

Characterize Nanomaterials in Food Additives & Product’s Final Form

*

*



100 nm 100 nm


Nano in Pharmaceuticals Comprehensive Physicochemical Characterization of Materials in Relevant Media - in vitro and in vivo by TEM






Regular ( Vacuum, Dry)

Stained ( Vacuum, Dry)

Cryo ( Vacuum, Freeze)

K-kit ( Aqueous, Original)

Microtome ( Vacuum, Freeze or Plastic)

MSNs in liver Resovist® in blood Liposomes Influenza virus PLGA particles

*Liquid sample TEM (K-kit) Enclosed specimen holder for observing liquid sample in TEM, preserving the original morphology

and physical state of nanomaterials under TEM observation. ** PLGA: poly(lactic-co-glycolic acid); MSNs: mesoporous silica nanoparticles

Direct Observation in Relevant Media

In vivo In vitro Material

Test tube Cell culture Blood Tissue

With Advanced Sample Preparation Techniques



Cryo-TEM Service

冷凍電子顯微鏡病毒、蛋白質及奈米材料之冷凍試片製備與分析服務

微脂體 Liposome

病毒 Virus

研磨液 Slurry

冷凍樣品製備技術能將樣品急速冷凍於玻璃態冰層中，並進入穿透式電子顯微鏡觀察，進一步提供關於各種生物樣品及奈米材料接近於液態環境中之樣貌、尺寸與聚集分佈的分析服務

冷凍微脂體 (Cryo-liposome) 可觀察微脂體原始含水樣貌，並清楚分辨雙層至多層膜結構

冷凍病毒顆粒 (Cryo-viral particle) 可觀察病毒於溶液中的原始形貌，表面醣蛋白結構明顯

冷凍研磨液 (Cryo-slurry) 可製備出研磨顆粒於原始研磨液中的自然分散狀態，並分析計算顆粒之尺寸與分布




Biological Morphology Service

樹酯包埋與

超薄切片

臨界點乾燥

負染

電子顯微鏡設備穿透式電子顯微鏡 (TEM)，掃描式電子顯微鏡 (SEM) 冷凍與常溫超薄切片機 (Cryo-ultramicrotome)，臨界點乾燥機 (CPD)

生物電子顯微鏡各類生物樣品之型態結構觀察與分析服務

細胞、生物組織與細菌等樣品可經由前置處理及超薄切片，於穿透式電子顯微鏡 (TEM) 中進行觀察分析

細胞切片，可清楚觀察細胞核與內質網等胞器結構

肌肉組織切片，可清楚觀察肌肉纖維排列與粒線體結構

細菌切片，可清楚觀察細菌及細胞壁厚度

生物器官與組織、細胞等樣品可經由前置處理與臨界點乾燥，於掃描式電子顯微鏡 (SEM) 中進行觀察分析

利用 SEM 觀察奈米顆粒結合於細胞表面的狀況

生物與有機樣品可經由負染增加對比,於穿透式電子顯微鏡 (TEM) 中觀察型態與細部結構

感冒病毒顆粒負染後於 TEM 觀察表面雙層結構

微脂體 (Liposomes) 負染後於 TEM 觀察尺寸與型態




Biomaterials and Relevant Products Service

生醫材料電子顯微鏡各類奈米生醫材料及產品應用之觀察與分析服務

電子顯微鏡設備穿透式電子顯微鏡 (TEM)，掃描式電子顯微鏡 (SEM) 冷凍與常溫超薄切片機 (Cryo-ultramicrotome)，臨界點乾燥機 (CPD)

粉餅與乳霜 - 化妝品原料及產品中各種奈米顆粒及乳化型態

製劑 - 病毒顆粒與疫苗製劑型態觀察

奈米劑型 - 各類奈米劑型合成與生物應用之觀察

敷料 - 織布纖維表面奈米金顆粒 (AuNP) 分布

醫材化妝品

疫苗醫藥

TiO2 粉餅超薄切片，可分析氧化鈦 (TiO2) 與二氧化矽 (SiO2)等奈米顆粒的尺寸大小，及在產品中的乳化團聚型態

以 SEM 觀察織布纖維型態 (左圖) 以 TEM 觀察織布纖維之橫截面超薄切片，分析纖維表面奈米金顆粒之大小與分布 (下圖)

觀察奈米金顆粒合成型態 (右下)，觀察奈米金顆粒於細胞中的分布位置 (左下)

分析病毒顆粒型態與疫苗製劑內容物之尺寸與佐劑成份




ma-tek - world leader in nano bio analysis the …...

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