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

2.

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

3.

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

4.

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

5.

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

6.

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

Call Us

Call Us Call Us

Call Us

Call Us

Call Us Call Us Call Us


Low Folate

Fatty Acid Free

Pooled

Low Vitamin B12

Low Vitamin D

Low Endotoxin

High Purity

Determine Your Albumin Concentration:1


Sodium Azide as a Preservative?3

7.

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


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

8.

Animal PlasmaDecision GuiDe (item number selection)

Purified Antigens & Antibodies ProductsDecision GuiDe (item number selection)

Determine Your Animal Of Choice:1


Sodium Azide as a Preservative?3

2

FetalCalf SheepMouseNormal

Calf PorcineBovine RabbitGoat

Charcoal Stripped, Delipidated

Delipidated & Heat Treated


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

9.

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

10.

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


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



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


Human Serum: Resin Stripped

Human Serum: Off the Clot


11.

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:


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







Human Albumin: 20% Solution

Human Albumin: Lyophilized


12.

Product:Item#:



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 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







Human Albumin: Lyophilized, Low B12

Human Albumin: Lyophilized, Fatty Acid Free


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


Product:Item#:




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







Human IGIV: 10% Solution


monobind inc. - products · phosphorus uric acid alkaline phosphatase ldh sgot/ast billirubin,...

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