奈米產業應用方案

奈米產業應用方案 Bio MA tek

Bio Material Analysis Technology Inc.
  • Comprehensive Physicochemical characterizations
  • Advanced Bio-EM sample preparation and image analysis
  • Proficient and Adequate Services.

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.

Liquid Sample TEM

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

Our Technology (K-kit)

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

圖-1
圖-2 (a)The loaded liquid sample is sealed and imaged by TEM in the native liquid environment.
(b)A proprietary sample preparation protocol preserves the original morphology and physical state with improved imaging resolution.

K-kit vs. Conventional

圖-3

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.

Nano in Products

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

Goes with the Emerging Trend
For Regulatory, Manufacturing, and R & D Purposes.

圖-4
Nano in Products

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.
Nano Characterization

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

Goes with the Emerging Trend
For Regulatory, Manufacturing, and R & D Purposes.

圖-5 Bio Ma-tek service, based on recommendations in ISO/TR 13014
Characterization

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.

Nano Characterization

Ingredients and Additives in Final Product

Goes with the Emerging Trend
For Regulatory, Manufacturing, and R & D Purposes.

Example – CaCO3 particles as food additives:

圖-6 Material,Comprehensive physicochemical characterization
Material
圖-7 Product,Size/size distribution of CaCO3 NOAAs in milk
Product
Nano in Cosmetics

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

Goes with the Emerging Trend
For Regulatory, Manufacturing, and R & D Purposes.

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)

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

圖-8 (a)Lotion; (b)Cream; (c)Powder

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.

Nano in Cosmetics

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

Goes with the Emerging Trend
For Regulatory, Manufacturing, and R & D Purposes.

圖-9 Lotion,ZnO NOAAs in Sunscreen
圖-10 (a)TEM images;(b)Size/size distribution
圖-11 Cream,TiO2 NOAAs in Sunscreen
圖-12 (a)TEM images;(b)Size/size distribution
圖-13 Powder,NOAAs in Foundation
圖-14 (a)TEM images;(b)Size/size distribution
Nano in Foods

Characterize Nanomaterials in Food Additives & Product’s Final Form

Goes with the Emerging Trend
For Regulatory, Manufacturing, and R & D Purposes.

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).

United 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.

圖-15 (a)As Additive V.S. (b)In Product

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.

Nano in Foods

Characterize Nanomaterials in Food Additives & Product’s Final Form

Goes with the Emerging Trend
For Regulatory, Manufacturing, and R & D Purposes.

Example – CaCO3 particles as milk additives

圖-16 Material,Comprehensive physicochemical characterization
Material
圖-17 Product,Size/size distribution of CaCO3 NOAAs in milk
Product

*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 in Pharmaceuticals

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

Goes with the Emerging Trend
For Regulatory, Manufacturing, and R & D Purposes.

Direct Observation in Relevant Media

圖-18
Direct Observation

With Advanced Sample Preparation Techniques

圖-19
With Advanced Sample Preparation Techniques

*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

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.

Bio-EM

Sample Preparation and Imaging Services of Biological Tissues on Electron Microscopes.

Equipment
Transmission Electron Microscope (TEM), Scanning Electron Microscope (SEM), Cryo- ultramicrotome, Critical Point Drying (CPD)

圖-20 Resin Embedded and Ultra-microtome
Resin Embedded
圖-21 Critical Point Drying
Critical Point Drying
圖-22 Negative Stain
Negative Stain
Bio-medical Materials

Nano- Bio- Medical materials EM imaging and analysis services

Equipment
Transmission Electron Microscope (TEM), Scanning Electron Microscope (SEM),Cryo- ultramicrotome, Critical Point Drying (CPD)

圖-23
Bio-medical Materials
Cryo-TEM

Cryo-Specimen Preparation and Analysis Service of Virus, Protein and the other Nano-material

Cryo-Specimen Preparation
The sample is preserved in a frozen-hydrated state by rapid freezing. To provide the Morphology, Size/Size distribution, and Aggregates/Agglomerates of Bio-Sample and Nano-material in Final Form or Relevant Media.

圖-24 Liposome:Cryo-Liposome could observe the hydrated appearance of Liposome and clearly define lipid bilayer and multilayer structure
圖-25 Virus:Cryo-Viral Particle could observe the native appearance of Virus in relevant media and clearly define surface glycoprotein structure
圖-26 Slurry:Cryo-slurry could prepare the native distribution state of Slurry in Final Form and analysis the size and size distribution of particle