Antihemophilic Products
|
|
- Garey Rose
- 6 years ago
- Views:
Transcription
1 Antihemophilic Products Factor VIII Only Advate Alphanate Eloctate Helixate FS Hemofil M Humate - P Koate - DVI Kogenate FS with Vial Adapter Kogenate FS with Bioset Monoclate - P NovoEight Recombinate Wilate Xyntha Xyntha Solofuse
2 Antihemophilic Products - Factor VIII Only asdhealthcare.com Product Advate Antihemophilic Factor Alphanate Contains von Willebrand Factor Eloctate Manufacturer Baxalta Inc. (800) baxalta.com advate.com Grifols (800) grifolsusa.com alphanate.com Biogen (855) eloctate.com myeloctate.com Indications Contraindications In adults and children with Hemophilia A: control and prevention of bleeding episodes; perioperative management; routine prophylaxis to prevent or reduce the frequency of bleeding. Advate is not indicated for the treatment of von Willebrand disease. Life-threatening hypersensitivity reactions, including anaphylaxis, to mouse or hamster protein or other constituents of the product (mannitol, trehalose, sodium chloride, histidine, Tris, calcium chloride, polysorbate 80, and/or glutathione) Control and prevention of bleeding episodes and perioperative management in adult and pediatric patients with Factor VIII (FVIII) deficiency due to hemophilia A. Surgical and/or invasive procedures in adult and pediatric patients with von Willebrand Disease (VWD) in whom desmopressin (DDAVP) is either ineffective or contraindicated. It is not indicated for patients with severe VWD (Type 3) undergoing major surgery Life threatening immediate hypersensitivity reactions, including anaphylaxis, to the product or its components Adults and children with Hemophilia A (congential Factor VIII deficiency) for: control and prevention of bleeding episodes, perioperative management, routine prophylaxis to prevent or reduce frequency of bleeding episodes; Eloctate is not indicated for the treament of von Willebrand disease Do not use in patients who have had life-threatening hypersensitivity reactions, including anaphylaxis, to ELOCTATE Product Source Recombinant Plasma Recombinant rfviiifc Labelling for Removal of Pathogenic Prions Viral Removal Half-Life Recovery Packaged Product Storage Storage After Reconstitution Stabilizer N / A Solvent-detergent treatment; immunoaffinity chromatography; cation exchange chromatography In patients >16 yrs: ± 4.15 hours; infants (1 month to <2 yrs): 8.86 ± 1.78; 2 to 5 yrs old: ± 1.94; 5 to 12 yrs old: ± 1.60; 12 to 16 yrs old: ± 3.72 hours In patients >16 yrs: 2.57 ± 0.53 IU / dl / IU / kg; infants (1 month <2 yrs): 1.96 ± 0.21; 2 to 5 yrs old: 2.05 ± 0.62; 5 to 12 yrs old: 2.21 ± 0.44; 12 to 16 yrs old: 2.26 ± 0.42 IU / dl / IU / kg Refrigerate at 2 8 C (36 46 F); RT 30 C (86 F) for 6 months; do not return to refrigerated temperature; Yes; manufacturing process includes steps that provide a reasonable assurance that low levels of a vcjd model agent, if present in the starting material, would be removed PEG fractionation, Affinity Chromatography and Salt precipitation 17.9 ± 9.6 hours in hemophilia A patients; 7.67 ± 3.3 hours for VWF: RCo in VWD patients; 21.6 ± 7.8 hours for FVIII: C in VWD patients 96.7 ± 14.5% (mean ± SD) hours in hemophilia A patients; 3.3 ± 1.5 (IU / dl) / (IU / kg) for VWF:RCo in VWD patients; 2.1 ± 0.6 (IU / dl) / (IU / kg) for FVIII:C in VWD patients 36 months, up to printed expiration date at 25 C (77 F); N / A Detergent treatment; 15 nm filtration Adults: 19.7 ± 2.3 hours; yrs: 16.4 ± 2.3 hours; 6-11 yrs: 14.6 ± 3.1 hours; 2-5 yrs: 12 ± 2.45 hours 2.26 IU / dl / IU / kg 2 8 C (36 F 46 F) refrigerate; RT 30 C (86 F) for 6 months; ; protect from light Use within 3 hours; do not store or refrigerate RT; use within 3 hours RT < 30 C; use within 3 hours In 5 ml reconstituted vial: Tris 10 mm, calcium chloride 1.7 mm, mannitol 3.2% (w / v), sodium chloride 90 mm, α, α-trehalose 0.8% (w / v), histidine 10 mm, glutathione (reduced) 0.08 mg / ml, polysorbate % (w / v); In 2 ml reconstituted vial: Tris 25 mm, calcium chloride 4.2 mm, mannitol 8% (w / v), sodium chloride 225 mm, α, α-trehalose 2% (w / v), histidine 25 mm, glutathione (reduced) 0.2 mg / ml, polysorbate % (w / v); the final product contains no more than 2 ng VWF / IU rahf, which will not have any clinically relevant effect in patients with von Willebrand disease Albumin added Diluent Volume 2 ml / 5 ml 5 ml / 10 ml 3 ml Sucrose, sodium chloride, L-histidine, calcium chloride and polysorbate 20 Available Sizes 250 / 500 / 1000 / 1500 / 2000 / 3000 / 4000 IU 250 / 500 / 1000 / 1500 / 2000 IU FVIII 250 / 500 / 750 / 1000 / 1500 / 2000 / 3000 IU Some products may be stored ambient. To help maintain product integrity, products will only be accepted for return when they are shipped according to the return guidelines of ASD Healthcare and the product s manufacturer.
3 Helixate FS CSL Behring (800) cslbehring-us.com helixatefs.com Control and prevention of bleeding episodes and peri-operative management in adults and children (0 16 years) with Hemophilia A; routine prophylaxis to reduce the frequency of bleeding episodes and the risk of joint damage in children with Hemophilia A without pre-existing damage Hemofil M Antihemophilic Factor ( Human ), Method M, Monoclonal Purified Baxalta Inc. (800) baxalta.com Hemophilia A for the prevention and control of hemorrhagic episodes Humate-P Contains von Willebrand Factor CSL Behring (800) cslbehring-us.com humate-p.com Hemophilia A for treatment and prevention of bleeding in adult patients; von Willebrand disease for the treatment of spontaneous and trauma-induced bleeding episodes and prevention of excessive bleeding during and after surgery; not indicated for the prophylaxis of spontaneous bleeding episodes in VWD Life-threatening hypersensitivity reactions, including anaphylaxis to mouse or hamster protein or other constituents of the product Hypersensitivity to the active substance, to excipients, or to mouse proteins Anaphylactic or severe systemic reaction to antihemophilic factor or VWF preparations Recombinant Plasma Plasma N / A N / A N / A Solvent detergent; ion exchange chromatography; monoclonal antibody immunoaffinity chromatography Solvent-detergent treatment; immunoaffinity chromatography; nanofiltration Cryoprecipitation; Al(OH)3 adsorption, glycine precipitation, NaCl precipitation studied in combination; heat treatment at 60 C for 10 hours in aqueous solution; lyophilization ± 1.82 hours (adult); 10.7 hours (children) 14.8 ± 3 hours 12.2 hours; 10.3 hours von Willebrand disease 2.2 ± 0.34 IU / dl / IU/kg (adult); 1.9 IU / dl / IU / kg (children) 2.0 IU / dl / IU / kg 2 IU / dl / IU / kg von Willebrand disease RT 25 C (77 F) for 12 months; ; protect from light 2 C 8 C (36 F to 46 F); RT < 30 C (86 F), until expiration date noted on the package; Up to 36 months at 25 C (77 F); RT; use within 3 hours RT; use within 3 hours Use within 3 hours Sucrose; glycine; histidine Contains a maximum of 12.5 mg / ml Albumin and per AHF International Unit; 0.07 mg polyethylene glycol (3350) and 0.39 mg histidine Albumin added 2.5 ml / 5 ml 10 ml 5 ml / 10 ml / 15 ml 250 / 500 / 1000 / 2000 / 3000 IU approximate F VIII activity 250 / 500 / 1000 / 1700 IU 600:250 / 1200:500 / 2400:1000 RCoF:FVIII While every effort has been made to ensure the accuracy and completeness of the information presented, the author, editor, or publisher cannot be responsible for any errors or omissions. All provided information is obtained from FDA approved product information ASD Healthcare. Chart updated November 2015.
4 Antihemophilic Products - Factor VIII Only asdhealthcare.com Product Koate -DVI Kogenate FS with Bioset Kogenate FS with Vial Adapter Monoclate-P Manufacturer Kedrion BioPharma, Inc. (855) kedrion.com koate-dviusa.com Bayer Healthcare (888) bayerhealthcare.com kogenatefs.com Bayer Healthcare (888) bayerhealthcare.com kogenatefs.com CSL Behring (800) cslbehring-us.com Indications Hemophilia A, for temporarily replacing the missing clotting factor in order to control or prevent bleeding episodes, or to perform emergency and elective surgery for patients with Hemophilia A Contraindications None Hypersensitivity to any components, mouse or hamster proteins Hemophilia A Hemophilia A Hemophilia A Hypersensitivity to any components, mouse or hamster proteins Hypersensitivity to mouse protein Product Source Plasma Recombinant Recombinant Plasma Viral Removal TNBP / polysorbate 80 treatment and dry heat Solvent detergent; ion exchange chromatography; monoclonal antibody immunaffinity chromatography Solvent detergent; ion exchange chromatography; monoclonal antibody immunaffinity chromatography Pasteurization; heat; precipitation Half-Life hours ± 2.62 hours ± 4.38 hours 17.5 hours Recovery 1.9% IU / kg 2.43 ± 0.60 IU / kg 2.11 ± 0.37 IU / kg 1.9 IU / dl / IU / kg Packaged Product Storage Storage After Reconstitution RT 25 C (77 F) for 6 months; RT 25 C for 12 months; ; protect from light 2 8 C (36 46 F) refrigerate for up to 30 months or expiration date; RT 25 C for 12 months or expiration date; ; protect from light; once stored at RT do not return to refrigeration RT 25 C (77 F) for 6 months; RT; use within 3 hours RT; use within 3 hours RT; use within 3 hours RT 37 C; use within 3 hours Stabilizer Glycine Sucrose; glycine; histidine Sucrose; glycine; histidine Albumin; no von Willebrand Factor Diluent Volume 5 ml / 10 ml 2.5 ml / 5 ml 2.5 ml / 5 ml 2.5 ml / 5 ml / 10 ml Available Sizes 250 / 500 / 1000 IU 250 / 500 / 1000 / 2000 / 3000 IU 250 / 500 / 1000 / 2000 / 3000 IU 250 / 500 / 1000 / 1500 IU approximate FVIII activity Some products may be stored ambient. To help maintain product integrity, products will only be accepted for return when they are shipped according to the return guidelines of ASD Healthcare and the product s manufacturer.
5 NovoEight Recombinate Antihemophilic Factor Wilate Contains von Willebrand Factor Xyntha Xyntha Solofuse Novo Nordisk (800) novonordisk-us.com novoeight.com Baxalta Inc. (800) baxalta.com recombinate.com Octapharma (888) octapharma.com wilateusa.com Pfizer Inc. (800) pfizer.com xyntha.com/solofuse Hemophilia A Hemophilia A for the prevention and control of hemorrhagic episodes; perioperative management von Willebrand disease in adult and pediatric patients for on-demand treatment and control of bleeding, and perioperative management of bleeding Hemophilia A Life-threatening hypersensitivity reactions, including anaphylaxis, to NovoEight or its components, including hamster proteins Life-threatening immediate hypersensitivity reactions, including anaphylaxis, to the product or its components, including bovine, mouse or hamster proteins Hypersensitivity with known anaphylaxis or severe systemic reaction to human plasma-derived products, any ingredient in the formulation or components of the container Life-threatening hypersensitivity, including anaphylaxis, to the product or its components, including hamster proteins Recombinant Recombinant; human albumin added as a stabilizer & excipient, is from plasma Plasma Recombinant Detergent treatment; nanofiltration Immunoaffinity column chromatography; ion exchange chromatography Solvent detergent treatment; terminal dry heat 100 C for 120 minutes; ion exchange chromatography Affinity chromotography; solvent detergent viral inactivation step; virus-retaining nanofiltration step hours in adults 14.6 ± 4.9 hours VWF: 15.8 ± 11 hours; FVIII: 19.6 ± 6.9 hours (IU / ml) / (IU / kg) in adults ~2.0 IU / dl / IU / kg VWF: RCo: 1.9 ± 0.4% IU / kg; FVIII: C: 2.2 ± 0.5 IU / kg 2 8 C (36 F 46 F) refrigerate for up to 30 months from the date of manufacture until the expiration date; RT 30 C (86 F) for 12 months; ; store in original package to protect from light RT; use within 4 hours; store the reconsituted product in the vial Sodium chloride; sucrose; calcium chloride dihydrate RT 30 C (86 F); 2 8 C (36 F 46 F) for 36 months; RT<25 C (77 F) for 6 months; once stored at room temperature, the product must not be returned to the refrigerator; 11.8 ± 6.2 hours 2.47 ± 0.84 IU / dl / IU / kg RT 25 C for 3 months; ; protect from light RT; use within 3 hours Use immediately RT; use within 3 hours In 5 ml reconstituted vial: 25 mg / ml Albumin (human), 0.40 mg / ml calcium, 3 mg / ml polyethylene glycol (3350), 360 meq / L sodium, 110 mm histidine, 1.5 μg / Factor VIII IU polysorbate-80 In 10 ml reconstituted vial: 12.5 mg / ml Albumin (human), 0.20 mg / ml calcium, 1.5 mg / ml polyethylene glycol (3350), 180 meq / L sodium, 55 mm histidine, 1.5 μg / Factor VIII (IU) polysorbate-80; the final product for both diluent sizes contains not more than 2 ng rvwf / IU rfviii, which will not have any clinically relevant effect in patients with von Willebrand disease 4 ml sodium chloride diluent 5 ml / 10 ml 5 ml / 10 ml 4 ml N / A Sucrose; sodium chloride; L-histadine; calcium; polysorbate / 500 / 1000 / 1500 / 2000 / 3000 IU 250 / 500 / 1000 / 1500 / 2000 IU 500 / 1000 IU R2 Kit: 250 / 500 / 1000 / 2000 IU; Xyntha Solofuse: (dual chamber syringe) 250 / 500 / 1000 / 2000 / 3000 IU While every effort has been made to ensure the accuracy and completeness of the information presented, the author, editor, or publisher cannot be responsible for any errors or omissions. All provided information is obtained from FDA approved product information ASD Healthcare. Chart updated November 2015.
6 Antihemophilic Products - Factor VIII Only Others asdhealthcare.com aspire. ASD Healthcare delivers. When you re in the business of saving lives, you depend on exceptional customer service from your healthcare partners. So when you want a life-saving medication within hours, or need an extensive range of plasma-derived and recombinant therapeutics, connect with ASD Healthcare. Our people are here to help you get the products you need, when you need them. That s standard business for us, a part of our True Blue culture that makes going the extra mile an ordinary part of our day. Others aspire to meet our exceptional service. ASD Healthcare simply delivers. Convenient Connection ASD Healthcare makes it easy to order and reorder your inventory any time, any day, anywhere. Connect at Customer Service Emergency on-call phone orders 365 / 24 / 7 Expedited orders for same-day delivery in 48 states Expertise and resources for access to critical care products Your Patients. Your Purpose. Our Priority.
Clotting Disorder Therapy
Last Review Date: October 13, 2017 Number: MG.MM.PH.25b Medical Guideline Disclaimer Property of EmblemHealth. All rights reserved. The treating physician or primary care provider must submit to EmblemHealth
More informationFactor Replacement Products. Hem/Onc Fellows 2017
Factor Replacement Products Hem/Onc Fellows 2017 Factor VIII concentrates: History and Current Issues 1950-1960 Fresh Frozen Plasma Mid 1960 Cryoprecipitate from FFP 1970s Lyophilized concentrates from
More informationCLOTTING FACTOR REPLACEMENT THERAPY
CLOTTING FACTOR REPLACEMENT THERAPY Coverage for services, procedures, medical devices and drugs are dependent upon benefit eligibility as outlined in the member's specific benefit plan. This Medical Coverage
More informationCLOTTING FACTORS AND COAGULANT BLOOD PRODUCTS
UnitedHealthcare Commercial Medical Benefit Drug Policy CLOTTING FACTORS AND COAGULANT BLOOD PRODUCTS Policy Number: 2018D0047K Effective Date: January 1, 2018 Table of Contents Page INSTRUCTIONS FOR USE...
More informationAntihemophilic Factor (Recombinant BDD) Fc Fusion Protein (Eloctate): Treatment Cost Comparison and Budget Impact Analysis
CADTH TECHNOLOGY REVIEW Antihemophilic Factor (Recombinant BDD) Fc Fusion Protein (): Treatment Cost Comparison and Budget Impact Analysis Product Line: Technology Review Version: 1.0 Issue Number: 2 Publication
More informationKOGENATE FS BAYER MIDDLE EAST
08-15 KOGENATE FS BAYER MIDDLE EAST Formulated with Sucrose DESCRIPTION is a sterile, stable, purified, nonpyrogenic, dried concentrate that has been manufactured using recombinant DNA technology. Kogenate
More informationClotting Factors and Coagulant Blood Products
Clotting Factors and Coagulant Blood Products Policy Number: 5.02.520 Last Review: 04/2018 Origination: 04/2016 Next Review: 04/2019 Policy Blue Cross and Blue Shield of Kansas City (Blue KC) will provide
More informationClinical Policy: Humate-P (Antihemophiliac Factor/von Willebrand Factor Complex Human) Reference Number: CP.MP.404
Clinical Policy: (Antihemophiliac Factor/von Willebrand Factor Complex Human) Reference Number: CP.MP.404 Effective Date: January 2008 Last Review Date: 12/16 See Important Reminder at the end of this
More informationPRINCIPLES OF CLOTTING FACTOR THERAPY IN HEMOPHILIA A and B
PRINCIPLES OF CLOTTING FACTOR THERAPY IN HEMOPHILIA A and B 2013 Carol K. Kasper, M.D. Hemophilia Treatment Center Los Angeles Orthopaedic Hospital 2400 South Flower Street Los Angeles, CA 90007 carolkasper@hotmail.com
More informationLonger acting/extended Half Life Products: Laboratory Monitoring
Longer acting/extended Half Life Products: Laboratory Monitoring Steve Kitchen Lead Clinical scientist Sheffield Haemophilia Centre & UK NEQAS Blood Coagulation Declaration of Interests -1 Speaker/ consultancy
More informationMASAC RECOMMENDATIONS CONCERNING PRODUCTS LICENSED FOR THE TREATMENT OF HEMOPHILIA AND OTHER BLEEDING DISORDERS (Revised April 2010)
MASAC Document #195 (Replaces Document #190) MASAC RECOMMENDATIONS CONCERNING PRODUCTS LICENSED FOR THE TREATMENT OF HEMOPHILIA AND OTHER BLEEDING DISORDERS (Revised April 2010) The following recommendation
More informationRECOMBINATE. [Antihemophilic Factor (Recombinant)] DESCRIPTION. Lyophilized Powder for Reconstitution for injection
RECOMBINATE [Antihemophilic Factor (Recombinant)] Lyophilized Powder for Reconstitution for injection Reconstitute with 5 ml of Sterile Water for Injection using BAXJECT II DESCRIPTION RECOMBINATE [Antihemophilic
More informationADVATE [Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Method] Safety and effectiveness: 10 years of clinical experience
ADVATE [Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Method] Safety and effectiveness: 10 years of clinical experience Alfonso Iorio, MD, PhD Health Information Research Unit & Hemophilia Program
More informationAlphanate (Antihemophilic Factor/von Willebrand Factor Complex [Human])
Alphanate (Antihemophilic Factor/von Willebrand Factor Complex [Human]) HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ALPHANATE safely and effectively.
More informationVirus Safety in Plasma- Derived Therapeutics: A Merck Perspective. IPFA Yogyakarta, March Louis Wong
Virus Safety in Plasma- Derived Therapeutics: A Merck Perspective IPFA Yogyakarta, March 2017 Louis Wong Associate director, Plasma Initiative, Asia-Pacific Content Regulatory Expectations for Plasma-Derived
More informationPRODUCT MONOGRAPH ADVATE. Antihemophilic Factor (Recombinant), Plasma/Albumin Free Method (rahf-pfm)
PRODUCT MONOGRAPH ADVATE Antihemophilic Factor (Recombinant), Plasma/Albumin Free Method (rahf-pfm) 250, 500, 1000, 1500, 2000 and 3000 International Units (IU) per vial Coagulant Manufactured by: Imported
More informationA. National Hemophilia Organization
A. National Hemophilia Organization Organization name Czech Society of Hemophilia City Prague Country Czechia Phone +420603580980 E-mail info@hemofilici.cz This form completed by: First name Vladimír Last
More informationCritical Quality Attributes for Blood Products. Tim Lee, Ph.D. OBRR/CBER/FDA 12 January 2009 WCBP
Critical Quality Attributes for Blood Products Tim Lee, Ph.D. OBRR/CBER/FDA 12 January 2009 WCBP 1 Disclaimer The views expressed during this presentation are my own and may not be those of the FDA 2 Blood
More informationHemophilia A and B Recombinant Factor Replacement Therapy - 5EU Drug Forecast and Market Analysis to 2024
Published on Market Research Reports Inc. (https://www.marketresearchreports.com) Home > Hemophilia A and B Recombinant Factor Replacement Therapy - 5EU Drug Forecast and Market Analysis to 2024 Hemophilia
More informationBiotechnology of Human Plasma-Derived Medicines in Scope of Collaboration Perspectives within The Central European Initiative
Biotechnology of Human Plasma-Derived Medicines in Scope of Collaboration Perspectives within The Central European Initiative Dr Vadim Sentchouk PHARMLAND LLC Deputy General Director PLASMAPHARM LLC General
More informationHuman Protein Process Sciences, Lille, France 2. Shabrawishi Hospital Blood Bank, Cairo, Egypt 3. University of Saskatoon, Canada
1 Human Protein Process Sciences, Lille, France 2 Shabrawishi Hospital Blood Bank, Cairo, Egypt 3 University of Saskatoon, Canada Why such a concept? Non-virally inactivated plasma components are still
More informationInternational Society Laboratory Hematology Milan, May Current and Emerging Approaches for Assessing von Willebrand disease (VWD) in 2016
International Society Laboratory Hematology Milan, 12-14 May 2016 Current and Emerging Approaches for Assessing von Willebrand disease (VWD) in 2016 Augusto B. FEDERICI Hematology and Transfusion Medicine
More informationA MANUFACTURING PROCESS TO OBTAIN A HIGHLY-PURIFIED TRIPLE-SECURED FIBRINOGEN PRODUCT
A MANUFACTURING PROCESS TO OBTAIN A HIGHLY-PURIFIED TRIPLE-SECURED FIBRINOGEN PRODUCT Maduell P, Domingo N, López L, Gensana M, Caballero S, Belda P, Gajardo R, Grancha S, Ristol P R&D Area, Instituto
More informationHemophilia Care Delivery in 2016: New factors and beyond factors Where do we go from here?
Hemophilia Care Delivery in 2016: New factors and beyond factors Where do we go from here? Ellis J. Neufeld MD, PhD Medical Director, Boston Hemophilia Center Egan Family Foundation Professor, Harvard
More informationHemophilia A and B Recombinant Factor Replacement Therapy - Argentina Drug Forecast and Market Analysis to 2024
Hemophilia A and B Recombinant Factor Replacement Therapy - Argentina Drug Forecast and Market Analysis to 2024 Hemophilia A and B Recombinant Factor Replacement Therapy - Argentina Drug Forecast and Market
More informationCategory Storage Shelf Life Additional Criteria
CE Update [blood banking/transfusion medicine] Blood Components for Hemostasis Jun Teruya, MD, DSc, and Glenn Ramsey, MD From the Department of Pathology, Northwestern University Medical School, Chicago.
More information*Sections or subsections omitted from the full prescribing information are not listed
HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use Kogenate FS safely and effectively. See full prescribing information for Kogenate FS. Kogenate FS
More informationNew Perspectives in Hemophilia Treatment
New Perspectives in Hemophilia Treatment Craig M. Kessler A variety of factor concentrates are currently available for replacement therapy for patients with hemophilia. These differ by several parameters,
More informationPHARMA DEVELOPMENT DIGEST HEMOPHILIA A
PHARMA DEVELOPMENT DIGEST HEMOPHILIA A Reprint from PDD Hematology April 2017 ANDERSON CONSULTING GROUP Overview Greylock Pharma Development Digest is a surveillance service designed for pharmaceutical
More informationOctapharma, a Swiss manufacturer
Parent Empowerment Newsletter LA Kelley Communications, Inc. inside 3 As I See It: Andy s Healthcare Cost Solution 4 Inhibitor Insights: Bypassing Agents: Which Product Is Better? 5 Transitions: Hemophilia
More informationFractionation Services and Recombinant Plasma Protein Products: Product Supply and Transitioning
Frequently sked uestions and Recombinant Plasma Supply and Transitioning Summary of product changes Red (underlined): not continuing Blue (bold): new Today s Product Mix Future Product Mix Product Size
More informationCurrent and Emerging Treatment Paradigms in the Management of Hemophilia
Current and Emerging Treatment Paradigms in the Management of Hemophilia Barbara A. Konkle, MD Associate Director, Washington Center for Bleeding Disorders Director, Clinical and Translational Research
More informationANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE MEDICINAL PRODUCT ReFacto AF 250 IU powder and solvent for solution for injection ReFacto AF 500 IU powder and solvent for solution for injection
More informationGuideline on core SmPC for human fibrinogen products
23 July 2015 EMA/CHMP/BPWP/691754/2013 Rev 1 Committee for Medicinal Products for Human Use (CHMP) Draft Agreed by Blood Products Working Party 27 November 2013 Adoption by CHMP for release for consultation
More informationPRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION FIBRYGA
PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION FIBRYGA Fibrinogen Concentrate (Human) Powder for Solution for Injection / Infusion, 1 g/vial ATC-Code: B02BB01 Manufactured by: Octapharma Pharmazeutika
More informationFactor VIII Concentrate Factor IX Complex (Coagulation Factors, II, VII, IX, X) Concentrate
Factor VIII Concentrate Factor IX Complex (Coagulation Factors, II, VII, IX, X) Concentrate Application for retention on the WHO Model List From: Plasma Protein Therapeutics Association (PPTA) 1. Summary
More informationLaboratory Aspects of recombinant porcine FVIII and extended half life concentrates
Laboratory Aspects of recombinant porcine FVIII and extended half life concentrates Rajiv K. Pruthi, M.B.B.S Co-Director, Special Coagulation Laboratory & Director, Mayo Comprehensive Hemophilia Center
More informationIG Production and Safety
IG Production and Safety Platelet Disorder Support Association July 20, 2013 Mary Gustafson, Vice President, PPTA Global Regulatory Policy Presentation Outline Introduction - PPTA Plasma Collection Final
More informationBest camp ever! It s awesome. It s awesome.
Fall 2013 Best camp ever! Best camp ever! This was the compliment heard most frequently at the awards ceremony on Thursday when parents came to pick up their campers after five days and four nights of
More informationExcipient Albumin CSL Behring Human Serum Albumin
Excipient Albumin CSL Behring Human Serum Albumin For more information, contact CSL Behring USA: (610) 878-4000 1020 First Avenue King of Prussia, PA 19406-0901 Switzerland: +41 31 344 44 44 Wandorfstrasse
More informationGUIDE FOR THE ASSESSMENT OF CLOTTING FACTOR CONCENTRATES
GUIDE FOR THE ASSESSMENT OF CLOTTING FACTOR CONCENTRATES 3 rd edition Prepared by Albert Farrugia, BSc, PhD for the World Federation of Hemophilia Published by the World Federation of Hemophilia (WFH)
More informationMASAC RECOMMENDATIONS CONCERNING PRODUCTS LICENSED FOR THE TREATMENT OF HEMOPHILIA AND OTHER BLEEDING DISORDERS (Revised August 2017)
MASAC Document #250 (Replaces Document #249) MASAC RECOMMENDATIONS CONCERNING PRODUCTS LICENSED FOR THE TREATMENT OF HEMOPHILIA AND OTHER BLEEDING DISORDERS (Revised August 2017) The document was approved
More informationCharacterization of the Recombinant Human Factor VIII Expressed in the Milk of Transgenic Swine. William Anderson Hodges
Characterization of the Recombinant Human Factor VIII Expressed in the Milk of Transgenic Swine William Anderson Hodges Thesis submitted to the faculty of the Virginia Polytechnic Institute and State University
More informationHERCEPTIN(R) Vials (150 mg)
Safety Data Sheet HERCEPTIN(R) Vials (150 mg) SECTION 1: Identification of the substance/mixture and of the company/undertaking 1.1. Product identifier Product name Product code Synonyms HERCEPTIN(R) Vials
More informationPrion Removal Capacity of Plasma Protein Manufacturing Processes
Prion Removal Capacity of Plasma Protein Manufacturing Processes 1 A data collection from PPTA member companies Presented by Nathan Roth, Ph.D. Director, Global Pathogen Safety CSL-Behring on behalf of
More informationCOMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS (CPMP) CORE SPC FOR HUMAN PLASMA DERIVED AND RECOMBINANT COAGULATION FACTOR IX PRODUCTS
The European Agency for the Evaluation of Medicinal Products Evaluation of Medicines for Human Use London, 29 June 2000 COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS (CPMP) CORE SPC FOR HUMAN PLASMA DERIVED
More informationProduct. Ni-NTA His Bind Resin. Ni-NTA His Bind Superflow. His Bind Resin. His Bind Magnetic Agarose Beads. His Bind Column. His Bind Quick Resin
Novagen offers a large variety of affinity supports and kits for the purification of recombinant proteins containing popular peptide fusion tags, including His Tag, GST Tag, S Tag and T7 Tag sequences.
More informationCommon Inherited Bleeding Disorders
CAA 2015 Annual Conference Common Inherited Bleeding Disorders Bob Miller, A October 8, 2015 VWF has two jobs Loosely bound to protect FVIII and tether to site of injury All other coagulation factors also
More informationGuideline on clinical investigation of recombinant and human plasma-derived factor IX products
21 July 2011 EMA/CHMP/BPWP/144552/2009 Committee for medicinal products for human use (CHMP) Guideline on clinical investigation of recombinant and human plasma-derived factor Draft Agreed by Blood Products
More informationEMA Workshop on Hemophilia Registries. Industry Perspectives
EMA Workshop on Hemophilia Registries Industry Perspectives - London Mary Gustafson Vice President Medical and Regulatory Policy Plasma Protein Therapeutics Association Industry Collaborators Thomas Barnett
More informationCOMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) DRAFT GUIDELINE ON THE CLINICAL INVESTIGATION OF RECOMBINANT FACTOR VIII AND IX PRODUCTS
European Medicines Agency Pre-authorisation Evaluation of Medicines for Human Use London, 19 July 2007 CPMP/BPWG/1561/99 rev.1 COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) DRAFT GUIDELINE ON THE
More informationBest Practices in Formulation and Lyophilization Development Proteins, mabs and ADCs
Best Practices in Formulation and Lyophilization Development Proteins, mabs and ADCs Best Practices in Formulation and Lyophilization Development The ultimate goal of formulation development is a stable
More informationNote: The taller 100 x 13 mm tube is not designed to run on the ACL TOP. Plasma after centrifugation of these tubes must be placed in sample cups.
Created Revised Reviewed Approved Lupus Insensitive aptt on the ACL TOP HEM 4.15.1 7/13/2012 4/11/2013 4/11/2013 4/11/2013 I. PRINCIPLE The activated partial thromboplastin time is a global screening procedure
More informationCapture of mouse monoclonal antibodies
Capture of mouse monoclonal antibodies by cation exchange chromatography Life Science Products Processing Capture of mouse monoclonal antibodies from cell culture supernatant by cation exchange chromatography
More informationMouse IGF-1 ELISA Kit
GenWay Biotech, Inc. 6777 Nancy Ridge Drive San Diego, CA 92121 Phone: 858.458.0866 Fax: 858.458.0833 Email: sales@genwaybio.com http://www.genwaybio.com Mouse IGF-1 ELISA Kit Catalog No GWB-ZZD063 Size
More informationCommon Inherited Coagulation Disorders. Inherited Coagulation Disorders. All coagulation factors and platelets in circulation (unactivated)
Common Inherited Coagulation Disorders Bob Miller, A 2017 Inherited Coagulation Disorders Brief review of coagulation Disorders related to platelet dysfunction (not the acquired thrombocytopenias) Disorders
More informationBovine Serum Albumin (BSA) ELISA Kit
Instruction Manual No. M-8100 Bovine Serum Albumin (BSA) ELISA Kit Cat. No. 8100, 96 tests For Detection and Quantitation of Residual Bovine Albumin (BSA) in biological solutions For research use only,
More informationNovel Technologies in Plasma Fractionation. Dieter Fassnacht
Novel Technologies in Plasma Fractionation Dieter Fassnacht Agenda Grifols Overview Grifols Engineering Innovations in - Pooling - Fractionation - Filling Developing new technologies to provide innovative
More informationSensoLyte Anti-alpha-Synuclein Quantitative ELISA Kit (Human/Mouse/Rat) *Colorimetric*
Catalog # Kit Size SensoLyte Anti-alpha-Synuclein Quantitative ELISA Kit (Human/Mouse/Rat) *Colorimetric* AS-55550 One 96-well strip plate This kit is optimized to detect human/mouse/rat alpha-synuclein
More informationPlasma Fractionation Today and in the Future Plasma Product Biotechnology Meeting
Plasma Fractionation Today and in the Future 2013 Plasma Product Biotechnology Meeting 1 What we do matters Dayna and her husband, Brian, are the parents of four wonderful, amazing children, Charlie, Kate,
More informationSCIENTIFIC DISCUSSION
SCIENTIFIC DISCUSSION This module reflects the initial scientific discussion for the approval of BeneFIX. This scientific discussion has been updated until 1 September 2000. For scientific information
More informationA Quest For Unusual Infusion Stories
winter 2009 INSIDE Hemophilia and the Military Life page 4 Homework Before You Even Get to College page 10 Transitioning to the College Experience page 12 Off to College page 17 A publication of A Quest
More informationCurrent laboratory practices in the diagnosis and management of haemophilia
Current laboratory practices in the diagnosis and management of haemophilia Marc Jacquemin University of Leuven BSTH 2013 Detection of severe haemophilia A Validation of the FVIII assay for the detection
More informationChallenges in Managing Acute Bleeding in Patients with Hemophilia
Challenges in Managing Acute Bleeding in Patients with Hemophilia Presented as a Webcast at the 47 th ASHP Midyear Clinical Meeting and Exhibition Tuesday, December 4, 2012 Las Vegas, Nevada Planned and
More informationFORMULATION & LYOPHILIZATION CYCLE DEVELOPMENT OF AN ADC
FORMULATION & LYOPHILIZATION CYCLE DEVELOPMENT OF AN ADC A Case Study Wendy Saffell-Clemmer Director, R&D Baxter BioPharma Solutions Antibody Drug Conjugates (ADCs) are complex molecules consisting of
More informationStore samples to be assayed within 24 hours at 2-8 C. For long-term storage, aliquot and freeze samples at -20 C. Avoid repeated freeze-thaw cycles.
Human Retinol Binding Protein 4, RBP4 ELISA Kit Preparation Plate Washing Discard the solution in the plate without touching the side walls. Blot the plate onto paper towels or other absorbent material.
More informationAVB Sepharose High Performance
GE Healthcare Life Sciences Data file 28-927-54 AB Custom designed media AVB Sepharose High Performance AVB Sepharose High Performance is an affinity chromatography medium (resin) designed for the purification
More informationKogenate FS: antihemophilic factor rfviii-fs
DRUG PROFILE Kogenate FS: antihemophilic factor rfviii-fs Jeanne Lusher & Meera Chitlur Author for correspondence Children s Hospital of Michigan, 3901 Beaubien Boulevard, Detroit, MI 48201, USA Tel.:
More informationProduct Permission Document (PPD) of Botulinum Toxin Type A for Injection Ph.Eur Purified Neurotoxin Complex
Product Permission Document (PPD) of Botulinum Toxin Type A for Injection Ph.Eur Purified Neurotoxin Complex Brand Name : BOTO GENIE 1. Introduction : BOTO GENIE (Botulinum Toxin Type A for Injection Ph.Eur)
More informationMATF Antigen Submission Details and Standard Project Deliverables
MATF Antigen Submission Details and Standard Project Deliverables What we require when you submit your antigen: Proteins For a recombinant protein target, we require a minimum of 400µg soluble recombinant
More informationHERCEPTIN Vials 60 mg
Safety Data Sheet HERCEPTIN Vials 60 mg according to Regulation (EU) nr. 1907/2006 SECTION 1: Identification of the substance/mixture and of the company/undertaking 1.1. Product identifier Product name
More informationGST Fusion Protein Purification Kit
Glutathione Resin GST Fusion Protein Purification Kit Cat. No. L00206 Cat. No. L00207 Technical Manual No. TM0185 Version 01042012 Index 1. Product Description 2. Related Products 3. Purification Procedure
More informationANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked
More informationThe practical task of monoclonal IgG purification with CHT TM ceramic hydroxyapatite
The practical task of monoclonal IgG purification with CHT TM ceramic hydroxyapatite Pete Gagnon, Jie He, Paul Ng, Julia Zhen, Cheryl Aberin, Heather Mekosh 11th Annual Waterside Conference, Chicago, May
More informationCombining DOE with an empirical approach to improve vaccine formulation development
Engineering Conferences International ECI Digital Archives Vaccine Technology VI Proceedings 6-13-2016 Combining DOE with an empirical approach to improve vaccine formulation development Jill Livengood
More informationThe use of enhanced half-life coagulation factor concentrates in routine clinical practice: guidance from UKHCDO
Haemophilia (2016), 22, 487 498 DOI: 10.1111/hae.13013 REVIEW ARTICLE The use of enhanced half-life coagulation factor concentrates in routine clinical practice: guidance from UKHCDO P. COLLINS,* E. CHALMERS,
More informationGuideline on clinical investigation of recombinant and human plasma-derived factor IX products
21 May 2015 EMA/CHMP/BPWP/144552/2009 Rev. 1, Corr. 1 * Committee for medicinal products for human use (CHMP) Guideline on clinical investigation of recombinant and human plasma-derived factor Draft Agreed
More informationMolecular Origins of Recombinant Factor VIII (rfviii) Stabilization with Pluronic F68. Katherine M. Tadehara A PROJECT.
Molecular Origins of Recombinant Factor VIII (rfviii) Stabilization with Pluronic F68 By Katherine M. Tadehara A PROJECT Submitted to Oregon State University University Honors College In partial fulfillment
More information1. Bloomsbury BBSRC Centre for Structural Biology, Birkbeck College and University College London.
Purification/Polishing of His-tagged proteins - Application of Centrifugal Vivapure Ion-exchange Membrane Devices to the Purification/Polishing of Histagged Background Multi-milligram quantities of highly
More informationPlanova as a Virus Barrier for Biopharmaceutical Plasma Products
Planova as a Virus Barrier for Biopharmaceutical Plasma Products Tomo Miyabayashi Technical Marketing Bioprocess Division Asahi Kasei Medical Co., Ltd March 9 th, 2016 IPFA ASIA PACIFIC WORKSHOP Taipei
More informationApplication Note. Author. Abstract. Biopharmaceuticals. Verified for Agilent 1260 Infinity II LC Bio-inert System. Sonja Schneider
Combining small-scale purification and analysis of monoclonal antibodies on one instrument Protein purification with high-volume injection using the Agilent 126 Infinity Bio-inert Quaternary LC System
More informationHealthcare INDEPENDENT RESEARCH. Healthcare
INDEPENDENT RESEARCH Healthcare t October 2016 Haemophilia: «Stemming the bleed» Healthcare SHIRE PLC BUY FV 6900p Bloomberg SHP LN Reuters SHP.L Price 5176p High/Low 5323/3480p Market cap. GBP46,738m
More informationSYNAGIS (palivizumab) injection, for intramuscular use Initial U.S. Approval: 1998
US-10672 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use SYNAGIS safely and effectively. See full prescribing information for SYNAGIS. SYNAGIS (palivizumab)
More informationAssayMax Human Transferrin ELISA Kit
AssayMax Human Transferrin ELISA Kit Assaypro LLC 3400 Harry S Truman Blvd St. Charles, MO 63301 T (636) 447-9175 F (636) 395-7419 www.assaypro.com For any questions regarding troubleshooting or performing
More informationHuman IgG Antigen ELISA Kit
Human IgG Antigen ELISA Kit Catalog No: IHUIGGKT Lot No: SAMPLE INTENDED USE This human immunoglobulin G antigen assay is intended for the quantitative determination of total human IgG antigen in serum,
More informationMouse Factor XII Total ELISA Kit
Mouse Factor XII Total ELISA Kit Catalog No: IMFXIIKT-TOT Lot No: SAMPLE INTENDED USE This mouse coagulation Factor XII antigen assay is intended for the quantitative determination of total Factor XII
More informationAPOB (Human) ELISA Kit
APOB (Human) ELISA Kit Catalog Number KA1028 96 assays Version: 17 Intended for research use only www.abnova.com Table of Contents Introduction... 3 Background... 3 Principle of the Assay... 3 General
More informationDeveloping Robust and Efficient IEX Methods for Charge Variant Analysis of Biotherapeutics Using ACQUITY UPLC H-Class System and Auto Blend Plus
Developing Robust and Efficient IEX Methods for Charge Variant Analysis of Biotherapeutics Using ACQUITY UPLC H-Class System and Auto Blend Plus Robert Birdsall, Thomas Wheat, and Weibin Chen Waters Corporation,
More informationAn effective platform for purification of IgM monoclonal antibodies using Hydroxyapatite
An effective platform for purification of IgM monoclonal antibodies using Hydroxyapatite Frank Hensel, Patrys, GmbH Pete Gagnon, Validated Biosystems 5th International Conference on Hydroxyapatite and
More informationSandwich High Sensitivity ELISA kit for Quantitative Detection of Human VEGF in cell culture supernates, serum, and plasma (heparin, EDTA, citrate).
GenWay Biotech, Inc. 6777 Nancy Ridge Drive San Diego, CA 92121 Phone: 858.458.0866 Fax: 858.458.0833 Email: techline@genwaybio.com http://www.genwaybio.com Human VEGF ELISA Kit Catalog Number: Size: GWB-ZZK029
More informationHaemophilia Registries quantity versus quality
www.pei.de Haemophilia Registries quantity versus quality The current situation in Europe Christine Keipert Workshop on Haemophilia Registries July 1 st, 2015 Topics From local to global: The current state
More informationDate: September 11, 2017 Reference No.: FDAA17008
Date: September 11, 2017 Reference No.: FDAA17008 VIA WEB Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, rm. 1061 Rockville, MD 20852 SUBJECT: Draft Standardization
More information2. QUALITATIVE AND QUANTITATIVE COMPOSITION. Active substances Human fibrinogen, Coagulation Factor XIII (human), Aprotinin (bovine)
1. NAME OF THE MEDICINAL PRODUCT 0.5 ml, 1 ml, 3 ml Powders and solvents for sealant. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Qualitative composition Combi-Set I: Active substances Human fibrinogen,
More informationCOMPONENT NAME COMPONENT # QUANTITY STORAGE SHELF LIFE FORMAT. Store at 2-8 C. Do not freeze. Store at 2-8 C. Do not freeze.
This document is available at www.stemcell.com/pis EasySep Mouse CD90. Kit II Catalog #89 For processing x 0^9 cells Description Isolate highly purified CD90.+ (Thy.+) cells from mouse splenocytes or other
More informationKey Issues Dialogue: Hemophilia Featuring thought leaders in the hemophilia community. Biotherapies for Life
Key Issues Dialogue: Hemophilia Featuring thought leaders in the hemophilia community Biotherapies for Life CSL Behring produces safe, high-quality plasma-derived biotherapies for the treatment of hemophilia
More information