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Haematologic Technologies, Inc.

6 Orders Completed
Essex Junction, Vermont, US

About Haematologic Technologies, Inc.

Haematologic Technologies, Inc. (HTI), is both a manufacturer and service provider that specializes in the blood coagulation system. HTI purifies proteins involved in the coagulation cascade, as well as the regulation of bone metabolism. The HTI product line consists of over 150 highly purified and... Show more »

Haematologic Technologies, Inc. (HTI), is both a manufacturer and service provider that specializes in the blood coagulation system. HTI purifies proteins involved in the coagulation cascade, as well as the regulation of bone metabolism. The HTI product line consists of over 150 highly purified and well-characterized proteins including zymogens, enzymes, cofactors, and inhibitors as well as a complementary line of monoclonal and polyclonal antibodies intended for in-vitro research use. Also available are factor deficient plasmas and customized, blood collection tubes made-to-order for clinical research.

GMP services available include analytical testing for IVIGs (such as thrombin generation assays), analysis & characterization assays for biotherapeutics, stability & release testing as well as host cell protein evaluation.

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Our Services (35)


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Coagulation Factor Activity Assay

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Batch Release Testing

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ICH Stability Testing

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Thrombin Generation Tests

Price on request

Immune globulin intravenous (IGIV) drugs are sterilized solutions of antibodies made from human plasma, and are used to treat primary immune deficiency and other immune-related conditions. IGIV drugs have, however, been linked to thrombotic events mediated largely by coagulation factor XI(a), which co-purifies with immune globulin... Show more »

Immune globulin intravenous (IGIV) drugs are sterilized solutions of antibodies made from human plasma, and are used to treat primary immune deficiency and other immune-related conditions. IGIV drugs have, however, been linked to thrombotic events mediated largely by coagulation factor XI(a), which co-purifies with immune globulin as a contaminant. As a result, IGIV drug manufactures are recommended to routinely test the thrombogenicity of their IGIV product via detection of XI(a) in a specially designed thrombin generation assay (TGA).

Haemtech Biopharma Services (HBS) can develop, validate and perform thrombogenicity assays on your IGIV drug product. In addition, we can develop and manufacture the appropriate control for these assays. Each test method and control is developed specifically for your product using state-of-the-art concepts, techniques, reagents and instrumentation. HBS will then implement the assays by testing your samples in-house in our European Medicines Agency -certified, cGMP testing facility.

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Host Cell Protein (HCP) Detection

Price on request

With methods to identify and quantify HCPs along with the experience to help remove them from your manufacturing process, we offer an all-under-one-roof solution to your host cell protein challenges.

Methods for HCP detection and quantitation:

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1D/2D SDS-PAGE | SEC-HPLC for HMW impurity detection
IEX-HPLC... Show more »

With methods to identify and quantify HCPs along with the experience to help remove them from your manufacturing process, we offer an all-under-one-roof solution to your host cell protein challenges.

Methods for HCP detection and quantitation:

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1D/2D SDS-PAGE | SEC-HPLC for HMW impurity detection
IEX-HPLC and RP-HPLC for impurity identification | 1D/2D Western blot – for HCPs & product quantitation
Commercial HCP ELISA evaluation and method execution | LC-MS/MS proteomic analysis for HCP identity
LC-MRM targeted quantitative proteomics analysis | Develop, validate, and run ELISAs for specific HCPs in product or process samples
Specialized immunochemical methods for immunogenic HCP identification in cases where patients have developed anti-HCP antibodies |

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Product Stability Testing

Price on request

For Biotherapeutics and IVD/POC reagents

Accelerated and real-time stability studies to determine the shelf-life of your drug product under various temperature and humidity conditions. Lot release testing services when you are ready to go from development to commercialization.

Stability Storage Conditions | Methods &... Show more »

For Biotherapeutics and IVD/POC reagents

Accelerated and real-time stability studies to determine the shelf-life of your drug product under various temperature and humidity conditions. Lot release testing services when you are ready to go from development to commercialization.

Stability Storage Conditions Methods & Compliance Specializing in
-70oC +/- 10oC Compedial IVIG drug products
-20oC +/- 5oC Client transferred Recombinant clotting factors
5oC +/- 3oC Custom developed/validated Plasma-derived proteins
25oC +/- 2oC / 60% +/- 5% RH cGMP, cGLP and cGCP
30oC +/- 2oC / 65% +/- 5% RH ICH, USP and EP
40oC +/- 2oC / 75% +/- 5% RH See methods on Drug Development Services page
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Drug Development

Price on request

Analysis & characterization assays for biotherapeutics

Providing analytical support for your biopharmaceutical from early evaluation of APIs through stability & release of your commercial drug product.

Applications:

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Thrombogenicity | Anti-drug antibody testing | Potency of coagulation... Show more »

Analysis & characterization assays for biotherapeutics

Providing analytical support for your biopharmaceutical from early evaluation of APIs through stability & release of your commercial drug product.

Applications:

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Thrombogenicity | Anti-drug antibody testing | Potency of coagulation proteins | Purity of proteins
Structural characterization | Pharmacokinetic studies | Protein purification methods | Forced degradation studies
Aggregate investigation | Custom assay development | Assay validation |

Methods:

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HPLC (SEC, RPC, IEC, Protein A) | SDS-PAGE (1D & 2D) | Western blot | Clotting assays
ELISA | Chromogenic assays | Thrombin generation assays | Mass spec
pH | Head space vacuum | Residual moisture | Post-translational modification
Refractive index | Total protein | Osmolality | Formulation assessment

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Product Testing Services

Price on request

For IVIG drug products

From R&D through validated assays for lot release, we offer a myriad of analytical methods to assess the identity, purity, and potential safety of your IVIG drug product to meet current regulatory requirements.

Methods for IVIG include:

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Thrombin generation assays |... Show more »

For IVIG drug products

From R&D through validated assays for lot release, we offer a myriad of analytical methods to assess the identity, purity, and potential safety of your IVIG drug product to meet current regulatory requirements.

Methods for IVIG include:

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Thrombin generation assays | Factor XIa | Protein G HPLC | PKA
Total protein | Na-Caprylate | Glycine | Hemagglutination (Anti-A & B)
Plasmin | Plasminogen | Anti-complement | Osmolality
Anti-D antibodies | Fc Function Test | NAPTT | pH
IgM Assay | Fibrinogen | IgG Sub-Class Characterization |
IgA Assay | SDS-PAGE | Size exclusion HPLC |

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Custom Sample Collection Tube Manufacturing

Price on request

Custom blood and sample collection tubes to your specifications

Create customized collection tubes for your clinical research studies. Manufactured to your specifications with contents that are specific to your needs.

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Various tube sizes, styles, and vacuum draws |
Screw-cap vials available |
Liquid or... Show more »

Custom blood and sample collection tubes to your specifications

Create customized collection tubes for your clinical research studies. Manufactured to your specifications with contents that are specific to your needs.

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Various tube sizes, styles, and vacuum draws |
Screw-cap vials available |
Liquid or lyophilized formulations that you create |
Batch sizes as small as one |
Quick turn around |
Non-sterile, research use only |

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Human Plasma and Serum

Price on request

Factor Deficient Plasmas. Without the IVD cost

For research use only, our factor deficient plasmas are immunodepleted, have a normal range of remaining factors, and are calibrated against IVD plasmas to ensure equivalent performance – all for about ½ the cost of IVD deficient plasma.

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Prothrombin deficient... Show more »

Factor Deficient Plasmas. Without the IVD cost

For research use only, our factor deficient plasmas are immunodepleted, have a normal range of remaining factors, and are calibrated against IVD plasmas to ensure equivalent performance – all for about ½ the cost of IVD deficient plasma.

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Prothrombin deficient | Factor X deficient
Factor V deficient | Factor XI deficient
Factor VII deficient | Factor XII deficient
Factor VIII deficient* | Antithrombin deficient
Factor IX deficient | Double deficient plasma**

  • Chemically depleted. CRIM+ ** Custom manufacture only
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Antibody Services

Price on request

For blot, ELISA, purification & more

A full complement of monoclonal and polyclonal antibodies against human and bovine coagulation proteins. Custom conjugated* and affinity purified versions are available.

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Anti Factor V & Va | Anti-Factor XII | Anti-Protein S |... Show more »

For blot, ELISA, purification & more

A full complement of monoclonal and polyclonal antibodies against human and bovine coagulation proteins. Custom conjugated* and affinity purified versions are available.

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Anti Factor V & Va | Anti-Factor XII | Anti-Protein S | Anti-vWF
Anti-Factor VII | Anti-Factor XIII | Anti-Osteonectin | Anti-Tissue Factor
Anti-Factor VIII | Anti-Plasminogen | Anti-Osteocalcin | Anti-Protein Z
Anti-Factor IX & IXa | Anti-Prothrombin | Anti-TAFI | Anti-Heparin Cofactor II
Anti-Factor X | Anti-Thrombin | Anti-TFPI | Anti-Fibrinogen
Anti-Factor XI | Anti-Protein C | Anti-Antithrombin | …and more!

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Protein Production

Price on request

Purified Proteins. Better quality = Better results

95% pure, fully functional and guaranteed.* Multi-species, active site-blocked, and conjugated versions available. Custom purification available upon request.

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Factor VII & VIIa | RVVV/RVVX/E. Carinatus | TAFI | Thrombospondin
Factor IX & IXa |... Show more »

Purified Proteins. Better quality = Better results

95% pure, fully functional and guaranteed.* Multi-species, active site-blocked, and conjugated versions available. Custom purification available upon request.

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Factor VII & VIIa | RVVV/RVVX/E. Carinatus | TAFI | Thrombospondin
Factor IX & IXa | Factor V & Va | Angiostatin | Vitronectin
Factor X & Xa | Fibronectin | Alpha-2-antiplasmin | R. Tissue Factor
Factor XI & XIa | Protein S | Protein Z | Bovine Lactadherin
Factor XII | Thrombomodulin | Fibrinogen Osteocalcin
Factor XIII & XIIIa | vWF & vWF VIII-free | Beta-2-glycoprotein 1 | Phospholipids
Plasminogen & Plasmin | Heparin Cofactor II | Osteonectin | Fluorogenic substrates
Protein C & aPC | Antithrombin III | Platelet factor 4 | CMK-protease inhibitors
Prothrombin & Thrombin | Corn Trypsin Inhibitor** | Beta-thromboglobulin | DAPA

  • Up to the expiration data on the product data sheet ** CTI blood collection tubes available
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Cells and Tissues

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Mammalian Models

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Protein Quantification

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Human Biospecimens

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Clinical Hematology

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Product Development, Testing, and Packaging

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Biology

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Biochemistry & Molecular Biology

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Rodent Models

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Animal Models and Studies

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Protein Services

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Project Management

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Manufacturing Services

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Assay Development

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Factor VIII Deficient Mouse Model

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Factor IX Deficient Mouse Model

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Mouse Models

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Clinical Laboratory Services

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Clinical Research

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Formulation Services

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Drug Discovery & Development

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Model Organisms

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Biospecimens

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Ryan Dorfman

Vice President of Operations

FileType/PDF Created with Sketch. AnalyticalAssays_Biotherapeutics.pdf

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FileType/PDF Created with Sketch. AntiDrugAntibodyTesting.pdf

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FileType/PDF Created with Sketch. HostCellProteinServices.pdf

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  • Positive review for Thrombin Generation Tests:

    July 2017

    "Working with Tom Dudler was a pleasure. The interaction was seamless and enjoyable. Lauren (Science Exchange) did a great job facilitating the interaction."

Haematologic Technologies, Inc. has not received any endorsements.