Monobind Inc. - Products · Phosphorus Uric Acid Alkaline Phosphatase LDH SGOT/AST Billirubin,...
Transcript of Monobind Inc. - Products · Phosphorus Uric Acid Alkaline Phosphatase LDH SGOT/AST Billirubin,...
Products
Products Manufactured by Monobind Inc. An ISO 13485 Certified Company Lake Forest, CA 92630 USA
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About MonobindSince its inception in 1978 Monobind, an ISO 13485 certified-
company, has pioneered in providing diagnostic tools to
healthcare professionals. The expertise acquired through years
of hard work has allowed Monobind significant penetration into
the immunoassay market. With a distributor network spanning
110+ countries in both developed and emerging markets,
Monobind is a global brand and leader in the field of diagnostic
immunoassay systems.
To achieve product integrity and value, Monobind has always
manufactured all essential reagents in-house. Over the years,
we’ve refined our methods to create superlative materials
custom-fit to our product line, using the latest manufacturing
technology and materials from only the best sources.
Commercializing Raw MaterialsBecause of the lack of quality materials, Monobind decided to commercially offer its processed bio-matrices
and materials to diagnostic companies and researchers. The market favorably responded and today
Monobind produces essential materials for the majority of top diagnostic firms, maintaining coveted
approved-vendor status.
Key SuppliersMonobind has supply partnerships build on trust with the world’s largest blood fractionators. This gives us
priority access to Human Albumin, IVIG and other fractions for our usage and channeling into the diagnostic
market. We can meet small-to-large scale production requirements with batch sizes into the thousands of
liters.
High-Quality Matrices with Exact SpecificationsProcessing up to 30,000 liters of human plasma per year for both internal use and worldwide customers,
Monobind ranks among the largest producers. With expertise perfected through its immunoassay product
line, Monobind is able to remove endogenous hormones and antigens thereby meeting exact material-
profile specifications.
Based on the use-application, such may be accomplished with defibrination, charcoal or resin stripping,
with or without dilapidation. In addition, Monobind has proprietary procedures that can essentially
eliminate endogenous proteases and many endotoxins, which are detrimental to sensitive proteins and/or
peptides. Further, Monobind may provide preshipment samples for functionality testing and approval.
© 2019 Monobind, Inc. www.monobind.com
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Sample Certificate of Analysis PageHuman Serum - Charcoal Stripped 8Human Serum - Double Charcoal Stripped 8 Human Serum - Resin Stripped 9Human Serum - Off the Clot 9Human Albumin - 20% Solution 10Human Albumin - Lyophilized 10Human Albumin - Lyophilized, Lo B12 11Human Albumin - Lyophilized, Fatty Acid Free 11Human IGIV - 20% Solution 12
Other BiomaterialsAntigens & Antibodies 7
Human Biomaterials PageHuman Plasma 4Human Albumin 5Human IGIV 6Human Urine 6
Unique Selling Proposition & Plasma Overview PageMonobind Biomaterial Advantage 4Plasma Processing Overview 4
Animal Biomaterials PageAnimal Plasma 7
Page
MONOBIND BIOMATERIALS
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PLASMAOptions include: Source, Recovered, Fresh Frozen, OTC (Non-Gendered or
Normal Male)
© 2019 Monobind, Inc. www.monobind.com
Plasma Processing Chart
Monobind Biomaterial Advantage
Key Suppliers Largest fractionators & specialty blood banks - all FDA approved facilitiesTesting & Traceability Strict collection & testing criteria with plasma-lookback programsPriority Access Trusted channel for source plasma & fractionated materials Selection Extensive inventory of characterized materials, large lot sizes Material Quality Exceptional standards for diagnostic, non-injectable usage onlyCertifications Monobind is ISO 13485 certified and FDA registeredExpertise Internal product portfolio of 120+ immunoassaysKey Accounts Renown IVDs for bio-matrices, processed fractions, calibrators & QC controls
Defibrinated Plasma
Charcoal StrippedDefibrinated Plasma
Charcoal StrippedDelipidated
Defibrinated Plasma
DelipidatedResin Stripped
Defibrinated Plasma
For Example: HCY DepletedVitamin B Low, Anti TG /
AntiTPO, Single Donor Unit Samples, Calibrators &
Controls
Monobind typically stocks Raw Plasma, Defibrinated Plasma, Charcoal Stripped Defibrinated (2x),
Delipidated Defibrinated (2x) All other materials made per customer request and to exact specs, including salt and total protein count, pre-shipment samples and
customer authorization made prior to release of final product.
DelipidatedDefibrinated Plasma
Resin StrippedDefibrinated Plasma
Specialty Plasma
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Human Plasma Decision GuiDe (item number selection)
Determine Your Base Material1
Yes (We recommend 0.1% sodium azide)NoCustom preservative (let us know)
Sodium Azide as a Preservative?3Total protein countSpecific analyte values (enzyme, calcium, ALP)pH, electrolytes and other analytes ranges (provide targets)
Analyte Profile4
3.5 liter jugs (recommended to reduce freight/ ensure transport temp)10 liter jugsOther (1, 2, 3 liter or custom)
Pack Size?5
2X Charcoal Stripped
Protease free
Protease free
Protease free
Protease free
Protease free
Protease free
Protease free
Protease free
Defibrinated Protease free
Single Charcoal Stripped
Unprocessed plasma (Pooled or Single Donor)
Gendered
Charcoal Stripped, Delipidated
Resin Stripped
Delipidated, Resin Stripped
Delipidated
2X Charcoal Stripped, Delipidated
Speciality HCY Depleted,Low B12,Anti-Tg/TPO,15% T-Uptake, Calibrator Matrix etc.
103CM
174CM200CM
099CM
173RM
Yes/No
Source
5-5.3%Protein Content (typical native) 5.5-6% 5.5-6% 7%
176CM202CM
173CM
175CM201CM
177CM203CM
183CM
100CM209CM
098CM208CM
177RM
Yes/No
018CM204CM
Recovered
180CM206CM
097CM
198CM205CM
190CM207CM
185CM
104CM
101CM
174RM
Yes/No
170CM
FreshFrozen
182CM
191CM
096CM
095CM
245RM
Yes/No
245CM
171CM 246CM
OffThe Clot
Select The Product ThatMatches Your Needs:2
Call Us Call Us Call Us Call Us
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Human AlbuminDecision GuiDe (item number selection)
HA05SLB
HA05CS
HA05FAF
HA05S
5%
HA05SLB
HA10SLB
HA10CS
HA10FAF
10%
HA10SLB
HA20SLB
HA20CS
HA20FAF
HA20S
20%
HA20SLB
HA0CD
HA0DFAF
Lyophilized
HA0DEU
HA25SLB
HA25CS
HA25FAF
HA25S
25%
HA5SLB
Select The Product ThatMatches YourNeeds:2
HA10S HA00D
HA0DLB
HA0DLB
HA0DH
Call Us
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Call Us Call Us
Call Us
Call Us
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Single Charcoal Stripped
Low Folate
Fatty Acid Free
Pooled
Low Vitamin B12
Low Vitamin D
Low Endotoxin
High Purity
Determine Your Albumin Concentration:1
Yes (We recommend 0.1% sodium azide)NoCustom preservative (let us know)
Sodium Azide as a Preservative?3
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Human IGIV Decision GuiDe (item number selection)
Human UrineDecision GuiDe (item number selection)
Determine the Human Urine of Your Choice1Drug Free Urine – Raw & Pooled
Drug Free Urine Matrix – pH Treated
Drug-Free Urine Matrix - Sodium Azide pH - Treated
EtG/Cotinine Drug Free Urine Matrix – Sodium Azide & pH Treated
Custom Description
014CM
043CM
X
004CM
011RM
Determine your concentration of choice:1
Yes (We recommend 0.1% sodium azide)NoCustom preservative (let us know)
Sodium azide as a preservative?3
Paste
Purified IGIV05S
5%
GG23P
FractionII/III
HFIVP
Fraction IVLyophlized
IGIVDIGIV10S
10%Select The Product ThatMatches Your Needs:2
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Animal PlasmaDecision GuiDe (item number selection)
Purified Antigens & Antibodies ProductsDecision GuiDe (item number selection)
Determine Your Animal Of Choice:1
Yes (We recommend 0.1% sodium azide)NoCustom preservative (let us know)
Sodium Azide as a Preservative?3
2
FetalCalf SheepMouseNormal
Calf PorcineBovine RabbitGoat
Charcoal Stripped, Delipidated
Delipidated & Heat Treated
Single Charcoal Stripped
Delipidated
Heat and pH Treated
Select The Product ThatMatches Your Needs:
010CM Call UsCall Us194CM 184CM187CM Call UsCall Us
Call Us Call UsCall UsCall Us 186CMCall Us Call UsCall Us
Call Us Call UsCall UsCall Us Call Us804CM Call UsCall Us
Call Us 068CMCall Us193CM 188CM192CM 189CM075CM
Call Us 076CM078CMCall Us Call UsCall Us 080CM084CM
Quality Standard & affinity purified grades Validated Commercially proven reagents in Monobind assay products for manufacturing or research use
Product Key Features
ITEM # Description 1925015RM AFP 2525015RM IgE1825015RM CEA 625015RM LH Intact425015RM FSH Intact 626015RM LH Subunits426015RM FSH Subunits 725015RM PRL 825015RM hCG Intact 2125015RM PSA 2025015RM hCG Subunits 325015RM TSH Intact 1725015RM HGH 326015RM TSH Subunits
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Sample Certificate of Analysis
Product: Item#-Lot#: Preservative: Microbial:Filtration: Shelf Life & Storage: Bleed testing:
Defibrinated, Charcoal Stripped, Non-Lipid Stripped Human Serum3 Liters/BottleNone<10cfu/mL or no growthFiltered through a 0.22micron absolute membrane filter prior to bottlingFive years at -20˚C from date of manufactureAll units were tested at the donor level by FDA approved tests for Anti-HIV1&2, HCV, HTLV-1, HBsAg and RPR were found to be negative or non-reactive.
Analyte Result Method Analyte Result Method CalciumPhosphorusUric AcidAlkaline PhosphataseLDHSGOT/ASTBillirubin, TotalSGPT/ALTGGTPTotal ProteinAlbuminGlobulin
4.4 mg/dL1.5 mg/dL<2.0 mg/dL17 IU/L37 IU/L<4 U/L<1.0 mg/dL<4 U/L13 IU/L5.0 g/dL3.0 g/dL2.0 g/dL
SMACSMACSMACSMACSMACSMACSMACSMACSMACSMACSMACSMAC
BunCreatinineGlucoseTotal IronChlorideSodiumPotassiumTriglyceridesCholesterolIonized CalciumOsmorality
3 mg/dL<0.1 mg/dL<30 mg/dL73 µg/dL110 meq/L139 meq/L1.6 meq/L57 mg/dL104 mg/dL2.2 mg/dL260 mOSM/Kg
SMACSMACSMACSMACSMACSMACSMACSMACSMACSMACSMAC
Caution: For use in research or manufacturing in non-injectable products only. Not for use in human or clinical diagnosis.
Product: Item#: Preservative: Microbial: Filtration: Shelf Life & Storage:Bleed testing:
Defibrinated, Double Charcoal Stripped Human Serum 177CM or 190CMAs required< 10 cfu/mlFiltered through a 0.22micron absolute membrane filter prior to bottlingFive years at -20˚C from date of manufactureAll units were tested at the donor level by FDA approved tests for Anti-HIV1&2, HCV, HTLV-1, HBsAg and RPR were found to be negative or non-reactive.
Analyte Normal Range Analyte Normal RangeCalciumPhosphorusUric AcidAlkaline PhosphataseLDHSGOT/ASTTotal BilirubinSGTP/ALTGGTPTotal ProteinAlbuminGlobulinA/G RatioBUN
5.0 – 10 mg/dl2.5 – 4.5 mg/dl1.9 – 8.4 mg/dl30 – 130 IU/L60 – 225 IU/ml0.0 – 48 U/L0.1 – 1.4 mg/dl0.0 – 52 U/L0.0 – 65 IU/L5.0 – 8.0 gm/dl3.0 – 5.0 gm/dl2.0 – 4.0 gm/dl1.0 – 2.28.0 – 26 gm/dl
CreatininGlucoseTotal IronCholrideSodiumPotasiumTriglyceridesCholesterolIonized CalciumSerum OsmolalityAmmoniaT3 ValueT4 ValueCortisol
0.7 – 1.4 mg/dl65 – 114 mg/dl34 – 185 µg/dl95 – 110 mEQ/L130 – 150 mEQ/L1.0 – 5.5 mEQ/L< 15 mg/dl< 15 mg/dl1 – 4.7 mg/dl260 – 310 mOSM/Kg< 300 µmol/L0.0 ng/dl0.0 µg/ml0.0 µg/ml
CAUTION: For use in research or manufacturing in non-injectable products only. Not for use in human or clinical diagnosis.
Human Serum: Defibrinated, Charcoal Stripped
Human Serum: Defibrinated, Double Charcoal Stripped
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Product: MB Part#: Preservative: Microbial: Filtration: Shelf Life & Storage:Bleed testing:
Resin Stripped, Non-Lipid Stripped, Human Serum 097CM or 173CMAs required< 10 cfu/mlFiltered through a 0.22micron absolute membrane filter prior to bottlingFive years at -20˚C from date of manufactureAll units were tested at the donor level by FDA approved tests for Anti-HIV1&2, HCV, HTLV-1, HBsAg and RPR were found to be negative or non-reactive.
Analyte Normal Range Analyte Normal Range
CalciumPhosphorusUric AcidAlkaline PhosphataseLDHSGOT/ASTTotal BilirubinSGTP/ALTGGTPTotal ProteinAlbuminGlobulinA/G RatioBUN
5.0 – 10 mg/dl2.5 – 4.5 mg/dl1.9 – 8.4 mg/dl30 – 130 IU/L60 – 225 IU/ml0.0 – 48 U/L0.1 – 1.4 mg/dl0.0 – 52 U/L0.0 – 65 IU/L5.0 – 8.0 gm/dl3.0 – 5.0 gm/dl2.0 – 4.0 gm/dl1.0 – 2.28.0 – 26 gm/dl
CreatininGlucoseTotal IronCholrideSodiumPotasiumTriglyceridesCholesterolIonized CalciumSerum OsmolalityAmmoniaT3 ValueT4 Value
0.7 – 1.4 mg/dl65 – 114 mg/dl34 – 185 µg/dl95 – 110 mEQ/L130 – 150 mEQ/L1.0 – 5.5 mEQ/L10 – 190 mg/dl118 – 200 mg/dl1 – 4.7 mg/dl260 – 310 mOSM/Kg< 300 µmol/L0.0 ng/dl0.0 µg/ml
CAUTION: For use in research or manufacturing in non-injectable products only. Not for use in human or clinical diagnosis.
Product: Item#-Lot#: Preservative: Microbial:Shelf Life & Storage:Filtration: Storage:Bleed testing:
Analyte Result MethodCalciumPhosphorusUric AcidAlkaline PhosphataseLDHSGOT/ASTTotal BilirubinSGTP/ALTGGTPTotal ProteinAlbuminGlobulin
9.1 mg/dL3.7 mg/dL4.8 mg/dL13 IU/mL54 IU/mL4 U/L0.0 mg/dL <4 U/L35 IU/mL6.7 g/dL4.2 g/dL2.5 g/dL
SMACSMACSMACSMACSMACSMACSMACSMACSMACSMACSMACSMAC
CAUTION: For use in research or manufacturing in non-injectable products only. Not for use in human or clinical diagnosis.
Human Serum, Off The Clot245CM-24L05None<10cfu/mL or no growthFive years at -20˚C from date of manufactureFiltered through a 0.22micron absolute membrane filter prior to bottling-20˚CAll units were tested at the donor level by FDA approved tests for Anti-HIV1&2, HCV, HTLV-1, HBsAg and RPR were found to be negative or non-reactive.
Analyte ResultA/G RatioBUNCreatinine GlucoseTotal IronChlorideSodiumPotassiumTriglyceridesCholesterolIonized calciumOsmolality
1.712 mg/dL 0.8 mg/dL124 mg/dL59 mg/dL124 meq/L155 meq/L4.1 meq/L108 mg/dL156 mg/dL4.1 mg/dL321 mOSM/Kg
SMACSMACSMACSMACSMACSMACSMACSMACSMACSMACSMACSMAC
Human Serum: Resin Stripped
Human Serum: Off the Clot
Sample Certificate of Analysis
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Each plasma unit used in the preparation of human albumin was tested and found negative, for the following, by FDA licensed reagents.
Product:Item#:
Lot#:Fractionation Method:
Shelf Life & Storage: Purity:
Appearance:Plasma Type:
Origin Of Plasma:
Human Albumin 20% SolutionHA20S100RM-MBB-75616Cohn-Oncley Cold Alcohol ProcedureTen years at -20˚C from date of manufacture> 97% by SPE Gel ElectrophoresisFaint yellow-white colorPhoresis PlasmaFDA Licensed Facilities
• HIV I & II Antibodies• HCV Antibodies
• HBsAg• ALT (SGPT)
The plasma pool(s) were tested and found negative, for the following, by FDA licensed reagents.
• HIV I & II Antibodies• HCV Antibodies• HBsAg
• HBV, HCV, HIV-1 & HIV-2 (NAT Testing)
The antibody screening is performed on all Rh negative donors.Source plasma is collected from donors who have not been hyperimmunized to produce specific antibodies.
Each plasma unit used in the preparation of (human) IVIG was tested and found negative, for the following, by FDA licensed reagents.
Product:Item#:
Lot#:Shelf Life & Storage:
Fractionation Method:Purity:
Appearance:Plasma Type:
Origin Of Plasma:
Human Albumin LyophilizedHA00D089RM-MBB-58D16Ten years at -20˚C from date of manufacture Cohn-Oncley Cold Alcohol Procedure>96% by SPE Gel ElectrophoresisCream PowderPhoresis PlasmaFDA Licensed Facilities
• HIV I & II Antibodies• HCV Antibodies
• HBsAg• ALT (SGPT)
The plasma pool(s) were tested and found negative, for the following, by FDA licensed reagents.
• HIV I & II Antibodies• HCV Antibodies• HBsAg
• HBV, HCV, HIV-1 & HIV-2 (NAT Testing)
The antibody screening is performed on all Rh negative donors.Source plasma is collected from donors who have not been hyperimmunized to produce specific antibodies.
Human Albumin: 20% Solution
Human Albumin: Lyophilized
Sample Certificate of Analysis
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Product:Item#:
Lot#:Shelf Life & Storage:
Fractionation Method:Purity:
Key Analytes:Appearance:Plasma Type:
Origin Of Plasma:
Human Albumin Lyophilized, Low B12HA0DLB089RM-MBB-59G16Ten years at -20˚C from date of manufacture Cohn-Oncley Cold Alcohol Procedure>96% by SPE Gel ElectrophoresisFolate <1.0 ng/ml & Vitamin B12<80 pg/mlCream PowderPhoresis PlasmaFDA Licensed Facilities
Each plasma unit used in the preparation of (human) IVIG was tested and found negative, for the following, by FDA licensed reagents.
• HIV I & II Antibodies• HCV Antibodies
• HBsAg• ALT (SGPT)
The plasma pool(s) were tested and found negative, for the following, by FDA licensed reagents.
• HIV I & II Antibodies• HCV Antibodies• HBsAg
• HBV, HCV, HIV-1 & HIV-2 (NAT Testing)
The antibody screening is performed on all Rh negative donors.Source plasma is collected from donors who have not been hyperimmunized to produce specific antibodies.
Each plasma unit used in the preparation of human albumin was tested and found negative, for the following, by FDA licensed reagents.
Product:Item #:
Lot#:Fractionation Method:
Shelf Life & Storage: Purity:
Key Analytes:Appearance:Plasma Type:
Origin Of Plasma:
Human Albumin Lyophilized, Fatty Acid FreeHA0DFAF088RM-MBB-59G16Cohn-Oncley Cold Alcohol ProcedureTen years at -20˚C from date of manufacture>96% by SPE Gel ElectrophoresisFatty Acid 0.0mg/gCream PowderPhoresis PlasmaFDA Licensed Facilities
• HIV I & II Antibodies• HCV Antibodies
• HBsAg• ALT (SGPT)
The plasma pool(s) were tested and found negative, for the following, by FDA licensed reagents.
• HIV I & II Antibodies• HCV Antibodies• HBsAg
• HBV, HCV, HIV-1 & HIV-2 (NAT Testing)
The antibody screening is performed on all Rh negative donors.Source plasma is collected from donors who have not been hyperimmunized to produce specific antibodies.
Human Albumin: Lyophilized, Low B12
Human Albumin: Lyophilized, Fatty Acid Free
Sample Certificate of Analysis
13.© 2019 Monobind, Inc. www.monobind.com
For more information on any of these products, or to discuss your unique needs, please contact us:
Monobind Inc.100 North Pointe Dr.Lake Forest, CA 92630
Web: www.monobind.comEmail: [email protected] Phone: +1 949-951-2665Fax : +1 949-951-3539
Each plasma unit used in the preparation of (human) IVIG was tested and found negative, for the following, by FDA licensed reagents.
Product:Item#:
Lot#:Shelf Life & Storage:
Fractionation Method:Purity:
Appearance:Plasma Type:
Origin Of Plasma:
Human Gamma Globulin – IGIV – 10%IGIV10S105RM-47D16Ten years at – 20˚C from date of manufacture Cohn-Oncley Cold Alcohol Procedure> 98% by SPE Gel ElectrophoresisClear to opalescent colorless to pale yellowPhoresis PlasmaFDA Licensed Facilities
• HIV I & II Antibodies• HCV Antibodies
• HBsAg• ALT (SGPT)
The plasma pool(s) were tested and found negative, for the following, by FDA licensed reagents.
• HIV I & II Antibodies• HCV Antibodies• HBsAg
• HBV, HCV, HIV-1 & HIV-2 (NAT Testing)
The antibody screening is performed on all Rh negative donors.Source plasma is collected from donors who have not been hyperimmunized to produce specific antibodies.
Human IGIV: 10% Solution
Sample Certificate of Analysis