Haematologic Technologies, LLC. (HT), is a large molecule contract research organization (CRO) with a focus on pre-clinical through clinical programs. In addition to a wide range of services such as orthogonal host cell protein analysis using High-Resolution Mass Spectrometry and ELISA assays, HT provides capabilities across the ligan binding assay spectrum, including assay development using ELISA, quantitative Western Blot, through validation and verification of cGMP assays for release and stability testing of large molecule therapeutics.
HT provides purified protein products involved in the coagulation cascade and the regulation of bone metabolism. The HT 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, and host cell protein evaluation.
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.
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:
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 |
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|
Analysis & characterization assays for biotherapeutics
Providing analytical support for your biopharmaceutical from early evaluation of APIs through stability & release of your commercial drug product.
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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 |
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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
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 |
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.
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 |
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.
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**
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!
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
"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, LLC. has not received any endorsements.