biomaterials - werfen

Biomaterials:Design, ManufacturingServices and Products

Living Immunoassay Excellence

2 Biomaterials Catalogue

Innovation

Biokit ranks among the top centres of excellence for immunoassay development and manufacturing in the industry. Our focus on technological advances ensures that our portfolio continuously improves and evolves. Biokit’s innovative nature is strengthened through close relationships with the most prestigious universities and biotechnology research centres around the world in order to offer the best quality and state-of-the-art products.As experts in Infectious Disease Serology, we offer a wide range of products implementing a variety of technologies, most notably, chemiluminescence.

Commitment

Customers and patients benefit from the efficiency of a team of more than 270 highly qualified and specialised professionals, who apply their enthusiasm, energy and dedication on a daily basis in order to provide hospitals, blood banks and IVD OEM partners with high quality systems and reagents.

Quality

Biokit is commited with the quality in all the activities, offering maximum quality standards in all the products and services.

The Quality Assurance Department at Biokit is responsible for the Overall Quality of the Company. All processes are subject to strict controls, from the conception of and research into a new product, up to its final manufacturing and marketing. Compliance with various international standards is verified at all times.

The quality systems of Biokit, S.A. have been registered by UL to the ISO 13485:2003 Standard (certificate number A12230).

Biokit is a privately owned biotechnological company that is part of Werfen. It was founded in 1973 and is aimed at the research, development, manufacture and worldwide distribution of clinical diagnostic reagents and systems.

Our knowledge and experience mainly involve in vitro diagnostic markers, based on antigen- antibody reactions, in the fields of infectious diseases and serum proteins, among others.

Biokit’s mission is to become the partner of choice as a centre of excellence for immunoassay by providing innovative OEM solutions (products & services) to major IVD players.

3Biomaterials Catalogue

Abbreviations

Biokit offers its expertise in design and manufacturing biomaterials for large IVD manufacturers with proven results in diagnostic kits. More than 80 companies in the IVD industry rely on biomaterials and specialized OEM Products and Services from Biokit.

A280 Absorbance at 280 nm

Ab Antibody

ADV Adeno virus

Ag Antigen

CLIA Chemiluminescence

CMV Citomegalovirus

CPE Citopatic effect

DGU Density Gradient Ultracentrifugation

ELISA Enzyme-Linked ImmunoSorbent Assay

FDA Food and Drug Administration

GF Gel filtration

HBV Hepatitis B Virus

HCV Hepatitis C Virus

HEPES N-2-hydroxyethylpiperazine-N-2-ethane sulfonic acid

HIV Human Immunodeficiency Virus

HPLC High-performance liquid chromatography

IBES Improved Baculovirus Expression System

IVD In Vitro Diagnostics

mAb Monoclonal Antibody

Mfg PT Manufacturing Prototype lots

Mfg V&V Manufacturing Verification and Validation Lots

Nat Native

NTE NaCl-Tris-EDTA buffer

pAb Polyclonal Antibody

Rec Recombinant

SDS-PAGE Sodium Dodecys Sulfate - Polyacrylamide gel electrophoresis

TFF Tangential flow filtration

Biomaterials: Design andLarge Production Capacity


Biomaterials Manufacturing Capabilities & Services

Biokit offers its expertise in biomaterials manufacturing for large IVD manufacturers. If you need to outsource your in-house manufactured biomaterials, we can offer a high professional and dedicated solution.

We can implement your manufacturing procedures (expression, purification and characterization in our facilities to supply you with the high quality biomaterials you need in a timely and costly-efficient manner.

Biokit is dedicated to obtaining highly purified antigens and antibodies• Viral, bacterial and parasitological cultures• Synthetic peptides and recombinant proteins• Monoclonal antibodies from hybridoma cell cultures • Polyclonal antibodies from rabbit, goat and guinea pig

Growth Method Equipment Capacity

Human & monkey cells Roller Bottles 90 – 1000 bottles*

Insect & CHO cellsHybridomas

Spinner Flasks 1 Liter

Hollow Fiber 2.1 m2

Shaker Incubators 1 – 5 Liter

Stirrer Tank Bioreactor 2 – 50 Liter

Wave 25 – 100 Liter

Bacteria & YeastShaker Incubators 1 – > 10 Liter

Bioreactors 5 – 50 Liter

IBES technology** Insect rearing 0,5 mg/larva or pupa

Biomaterials Technologies Capacity

Human Plasmatic ProteinsRecombinant AntigensNative AntigensMonoclonal AntibodiesPolyclonal Antibodies

Salt Precipitation n/a

Density Gradient Ultracentrifugation (DGU)

n/a

Tangential Flow Filtration (TFF) n/a

Preparative Chromatography:

• Gel Filtration (GF) 10 mL - > 20 Liter

• Ion Exchange (anionic, cationic) 10 mL - > 2 Liter

• Affinity: metal-, tagged-, immuno-binding

10 mL - > 2 Liter

Methodology Description

Spectrophotometry Protein Measurement

Electrophoresis Profile PAGE (reducing, non-reducing conditions)

HPLC AKTA or Waters Systems

Functional Performance

Dot Blot

Western Blot

Immuno test (ELISA, Latex or CLIA technology)

Biacore *

Octet *

Expression systems

Analytical characterization

Purification

* Bottles of 810 cm2 or 1.700 cm2 capacity** IBES (Improved Baculovirus Expression System)

* only during feasibility stage


Biokit has implemented innovative technology for the large-scale production of recombinant proteins obtained in Baculovirus systems. This methodology uses an “In Vivo” expression system in which insect larvae are used as living bioreactors (IBES®*).

This process enables:• High batch-to-batch reproducibility• Rapid and linear scale up production process• Optimal recombinant protein conformation

* IBES® is a technology licensed by ALGENEX S.L.

Biomaterials Development & Manufacturing Services

Large-Scale Baculovirus Expression System Service

DEVELOPMENT

DevelopmentProcess PhaseConcept Phase

FEASIBILITY

Protein DesignExpression System

Protein Analysis

Process OptimizationProtein Characterization

Mfg PT Batches

Mfg V&V BatchesFunctional Evaluation

Biokit offers its expertise in Large-Scale Baculovirus Expression development and manufacturing for large IVD manufacturers. If you are experiencing challenges in the scalability of recombinant proteins using the Baculovirus system, we can help you through our innovative IBES® technology.

Using this technology, we can scale up your manufacturing expression procedure as well as implement your purification and characterisation processes in our facilities. In this way, we will be able to supply you with the amount of recombinant protein you require with no changes in the biomaterial functionality of your assay.


Biomaterials Products

Index

Biomaterials: Technologies and applications p. 7

Native antigens p. 8

Recombinant antigens p. 12

Polyclonal antibodies p. 19

Monoclonal antibodies p. 23

Sera p. 25

IVD technologies Processes

Turb

idim

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ELIS

A

Chem

ilum

ines

cenc

e

Rapi

d Te

st

Puri

ficat

ion

Imm

uniz

atio

n

Hepatitis B VirusNative antigens

Hepatitis B Surface6 (ad Subtype) 9Hepatitis B Surface Antigen (ay Subtype) 9

Recombinant antigensRecombinant HBs Antigen (ad Subtype) 13Recombinant HBs Antigen (ay Subtype) 13Recombinant HBc Antigen 14

Polyclonal antibodiesAnti-HBs Rabbit IgG pAb 20Anti-HBs Goat IgG pAb 20Anti-HBs Guinea Pig IgG pAb 20Anti-rHBc Rabbit IgG pAb 21

Monoclonal antibodiesAnti-HBs mAb (1DE2) 24

SeraAnti-HBs Goat Serum 26Anti-HBs Rabbit Serum 26

Hepatitis C VirusRecombinant antigens

Recombinant HCV Capsid Polypeptide 14Recombinant HCV NS3 Polypeptide 15

Treponema pallidumRecombinant antigens

Recombinant p15 Treponema pallidum Ag 15Recombinant p15 (II) Treponema pallidum Ag 15Recombinant p17 Treponema pallidum Ag 15Recombinant p47 Treponema pallidum Ag 16Recombinant H-p17 Treponema pallidum Ag 16Recombinant H-p47 Treponema pallidum Ag 16

Polyclonal antibodiesAnti-Treponema pallidum Rabbit IgG pAb 21

SeraAnti-Treponema pallidum Rabbit Serum 26

Toxoplasma gondiiNative antigens

Toxoplasma Gondii Soluble Ag 11Rubella VirusNative antigens

Rubella Antigen Grade A 10Rubella Antigen Grade B 10

Recombinant antigensRecombinant Rubella E1 Antigen 17Recombinant Rubella E2 Antigen 17

Herpes Simplex VirusRecombinant antigens

Recombinant gG1 Protein HSV-1 17Recombinant gG2 Protein HSV-2 18

CytomegalovirusNative antigens

Cytomegalovirus Antigen 11AdenovirusMonoclonal antibodies

Anti-Adenovirus mAb (2/6) 24Anti-Adenovirus mAb (20/11) 24

RotavirusSera

Anti-Rotavirus Rabbit Serum 26Polyclonal antibodies

Anti-Rotavirus Rabbit IgG pAb 22Epstein-Barr VirusNative antigens

Paul-Bunnell Antigen 11Trypanosoma cruzyRecombinant antigens

Recombinant TcF Chagas Ag 18RheumaRecombinant antigens

Recombinant Streptolysin-O 18Recombinant Streptolysin-O Stabilized 18

Polyclonal antibodiesAnti-Streptolysin O Rabbit IgG pAb 21Anti-C Reactive Protein Rabbit IgG pAb 22

Biomaterials:*Technologies/Applications

* Please note this table is merely indicative. For further technical information please contact [email protected]

Product Description Page



Native antigensProduct Description Presentation Reference Storage Page

Hepatitis B Surface Antigen (ad Subtype) 1 mg/vial 3000-5201 - 20 ºC 9

Hepatitis B Surface Antigen (ad Subtype) mg/custom size 3000-5200 - 20 ºC 9

Hepatitis B Surface Antigen (ay Subtype) 1 mg/vial 3000-5199 - 20 ºC 9

Hepatitis B Surface Antigen (ay Subtype) mg/custom size 3000-5198 - 20 ºC 9

Rubella Antigen Grade A 1 mg/vial 3000-5202 - 70 ºC 10

Rubella Antigen Grade A mg/custom size 3000-5204 - 70 ºC 10

Rubella Antigen Grade B 1 mg/vial 3000-5203 - 70 ºC 10

Rubella Antigen Grade B mg/custom size 3000-5205 - 70 ºC 10

Toxoplasma Gondii Soluble Ag 1 mL/vial 3000-5256 - 20 ºC 11

Toxoplasma Gondii Soluble Ag mL/custom size 3000-5252 - 20 ºC 11

Cytomegalovirus Antigen mg/custom size 3000-5260 - 70 ºC 11

Paul-Bunnell Antigen 1 mg/vial 3000-5286 - 70 ºC 11

Paul-Bunnell Antigen mg/custom size 3000-5287 - 70 ºC 11


Product Description Presentation Reference Storage

Hepatitis B VirusHepatitis B Surface Antigen (ad Subtype) 1 mg/vial 3000-5201 - 20 ºC**

Hepatitis B Surface Antigen (ad Subtype) mg/custom size* 3000-5200 - 20 ºC**

Hepatitis B Surface Antigen (ay Subtype) 1 mg/vial 3000-5199 - 20 ºC**

Hepatitis B Surface Antigen (ay Subtype) mg/custom size* 3000-5198 - 20 ºC**

* For large quantities, packaging available upon request - minimum size 5 mg/vial. ** Avoid repeated freezing and thawing.


Selling unit mg.Source Human plasma.Subtype ad.Form HBsAg in phosphate buffered saline pH 7.4.Purification Three ultracentrifugation steps.Purity 1. Silver stained SDS-PAGE under reducing conditions reveals two major bands correspoding to p24 and gp27. Bands corresponding to pre-S proteins, dimers, and 69 kDa protein are also detected. 2. 20 nm spherical particles were detected by electron microscopy, as well as rod particles in some lots. Complete virions (Dane particles, 42 nm) were not observed (done initially when the protocol was established).Protein concentration 2-3 mg/ml (A280/3.726).Preservative No preservative added.Inactivation Heat inactivated after purification (10 hours at 60 ºC). Although inactivated handle with appropriate precautions.HIV 1/2-Ab and HCV-Ab tests The human plasma units used as starting material have been found non-reactive for HIV 1/2 and HCV antibodies using a FDA approved assay.

Selling unit mg.Source Human plasma.Subtype ay.Form HBsAg in phosphate buffered saline pH 7.4.Purification Three ultracentrifugation steps.Purity 1. Silver stained SDS-PAGE under reducing conditions reveals two major bands correspoding to p24 and gp27. Bands corresponding to pre-S proteins, dimers, and 69 kDa protein are also detected. 2. 20 nm spherical particles were detected by electron microscopy, as well as rod particles in some lots. Complete virions (Dane particles, 42 nm) were not observed (done initially when the protocol was established).Protein concentration 2-3 mg/ml (A280/3.726).Preservative No preservative added.Inactivation Heat inactivated after purification (10 hours at 60 ºC). Although inactivated handle with appropriate precautions.HIV 1/2-Ab and HCV-Ab tests The human plasma units used as starting material have been found non-reactive for HIV 1/2 and HCV antibodies using a FDA approved assay.

Specifications

Specifications


Native antigensProduct Description Presentation Reference Storage

Rubella VirusRubella Antigen Grade A 1 mg/vial 3000-5202 - 70 ºC**

Rubella Antigen Grade A mg/custom size* 3000-5204 - 70 ºC**

Rubella Antigen Grade B 1 mg/vial 3000-5203 - 70 ºC**

Rubella Antigen Grade B mg/custom size* 3000-5205 - 70 ºC**



Selling unit mg.Source Tissue culture. Virus Strain: HPV-77. Host: Vero cells (african green monkey kidney).Buffer used Rubella antigen in approx. 20% sucrose / 0.02% SDS / NTE buffer.Purification Purified by ultracentrifugation.Purity > 90%. The three major bands standard for Rubella antigen are detected by SDS-PAGE.Protein concentration 0.5-1.5 mg/ml (modified Warburg-Christian method).Specific antigenic activity > 1000 EU/mg (measured by an “in house” capture ELISA).Preservative No preservative added.Inactivation Inactivated by detergent treatment (0.02% SDS). Although inactivated handle with appropiate precautions.

Selling unit mg.Source Tissue culture. Virus Strain: HPV-77. Host: Vero cells (african green monkey kidney).Buffer used Rubella antigen in approx. 40% sucrose / 0.02% SDS / NTE buffer.Purification Purified by ultracentrifugation.Purity > 90%. The three major bands standard for Rubella antigen are detected by SDS-PAGE.Protein concentration 0.1-0.5 mg/ml (modified Warburg-Christian method).Specific antigenic activity > 600 EU/mg (measured by an “in house” capture ELISA).Preservative No preservative added.Inactivation Inactivated by detergent treatment (0.02% SDS). Although inactivated handle with appropiate precautions.

Specifications

Specifications



Toxoplasma gondiiToxoplasma gondii Soluble Ag Treated 1 mL/vial 3000-5256 - 20 ºC**

Toxoplasma gondii Soluble Ag Treated mL/custom size* 3000-5252 - 20 ºC**

Epstein-Barr VirusPaul-Bunnell Antigen 1 mg/vial 3000-5286 - 70 ºC**

Paul-Bunnell Antigen mg/custom size* 3000-5287 - 70 ºC**

CytomegalovirusCytomegalovirus Antigen mg/custom size* 3000-5260 - 70 ºC**

* For large quantities, packaging available upon request - minimum size 5 ml/vial. ** Avoid repeated freezing and thawing.

* Packaging available upon request - minimum size 1 mg/vial. ** Avoid repeated freezing and thawing.


Selling unit mL.Source Intraperitoneal exudates from infected mice / Strain: RH.Form Detergent treated Toxoplasma gondii suspension in glycine buffered saline pH 9.0. The purity of the original material is higher than 100 toxoplasmas per cell.Protein concentration 2-8 mg/ml (Biuret method).Preservative < 0.1% sodium azide.

Selling unit mg.Source Tissue culture / Virus Strain: AD-169 / Host: Human foreskin cells.Form CMV antigens from all virus cycle replication in NTE buffer pH 8.0. Contains residual host cellular material.Protein concentration 0.4-0.7 mg/ml (modified Warburg-Christian method).Preservative No preservative added.Inactivation Detergent inactivated (0.015% SDS). Although inactivated handle with appropiate precautions.Infectivity assay After 15 days of incubation on a monolayer of Human foreskin cells, no cytopathic effect (CPE) must be observed.Handling Sonication is recommended prior to use.

Specifications

Specifications

Selling unit mg.Source Bovine red blood cellsBuffer used NonePurification Organic solvents extraction followed by ion Exchange chromatography.Protein concentration 0.5-2.5 mg/ml (Abs 280nm).Preservative 0.5 g/l sodium azide.

Specifications


Recombinant AntigensProduct Description Presentation Reference Storage Page

Recombinant HBs Antigen (ad Subtype) 50 mg/custom size 3000-5269 2-8 ºC 13

Recombinant HBs Antigen (ay Subtype) 50 mg/custom size 3000-5270 2-8 ºC 13

Recombinant HBc Antigen 1 mg/vial 3000-5100 -20 ºC 14

Recombinant HBc Antigen mg/custom size 3000-5102 -20 ºC 14

Recombinant HCV Capsid Polypeptide mg/custom size 3000-5103 -70 ºC 14

Recombinant HCV NS3 Polypeptide mg/custom size 3000-5104 -70 ºC 15

Recombinant p15 Treponema pallidum Ag mg/custom size 3000-5245 -70 ºC 15

Recombinant p15 (II) Treponema pallidum Ag mg/custom size 3000-5289 -70 ºC 15



Recombinant H-p17 Treponema pallidum Ag mg/custom size 3000-5254 -70 ºC 16

Recombinant H-p47 Treponema pallidum Ag mg/custom size 3000-5263 -70 ºC 16

Recombinant Rubella E1 Antigen 50 mg/custom size 3000-5261 -70 ºC 17

Recombinant Rubella E2 Antigen 50 mg/custom size 3000-5262 -70 ºC 17

Recombinant gG1 Protein HSV-1 0.5 mg/vial 3000-5288 -70 ºC 17

Recombinant gG1 Protein HSV-1 mg/custom size 3000-5279 -70 ºC 17

Recombinant gG2 Protein HSV-2 0.5 mg/vial 3000-5282 -70 ºC 18

Recombinant gG2 protein HSV-2 mg/custom size 3000-5283 -70 ºC 18

Recombinant TcF Chagas Ag 1 mg/vial 3000-5290 -70 ºC 18

Recombinant TcF Chagas Ag mg/custome size 3000-5291 -70 ºC 18

Recombinant Streptolysin-O 5 mg/vial 3000-5258 -70 ºC 18

Recombinant Streptolysin-O Stabilized 5 mg/vial 3000-5259 -70 ºC 18

NEW

NEW

NEW



Hepatitis B VirusRecombinant HBs Antigen (ad Subtype) 50 mg/custom size* 3000-5269 2-8 ºC

Recombinant HBs Antigen (ay Subtype) 50 mg/custom size* 3000-5270 2-8 ºC

* Packaging available upon request - minimum order 50 mg and minimum size 5mg/vial.

* Packaging available upon request - minimum order 50 mg and minimum size 5mg/vial.

Selling unit mg.Source Transformed Pichia pastoris.Subtype ad.Form rHBsAg in Tris-HCl buffer pH 8.0.Purification Immunoaffinity chromatography.Purity 1. SDS-PAGE under reducing conditions reveals one major band at 24 kDa which corresponds to the monomer. Bands at 44 and 64 kDa are also detected and correspond to monomer multimerization. 2. 20 nm spherical particles were detected by electron microscopy (done initially when the protocol was established).Protein concentration 0.8-1.5 mg/ml.Preservative No preservative added.

Selling unit mg.Source Transformed Pichia pastoris.Subtype ay. Form rHBsAg in Tris-HCl buffer pH 8.0.Purification Immunoaffinity chromatography.Purity 1. SDS-PAGE under reducing conditions reveals one major band at 24 kDa which corresponds to the monomer. Bands at 44 and 64 kDa are also detected and correspond to monomer multimerization. 2. 20 nm spherical particles were detected by electron microscopy (done initially when the protocol was established).Protein concentration 0.8-1.5 mg/ml.Preservative No preservative added.

Specifications

Specifications


Recombinant AntigensProduct Description Presentation Reference Storage

Hepatitis B VirusRecombinant HBc Antigen 1 mg/vial 3000-5100 -20 ºC**

Recombinant HBc Antigen mg/custom size* 3000-5102 -20 ºC**

Hepatitis C VirusRecombinant HCV Capsid Polypeptide mg/custom size* 3000-5103 -70 ºC**



Selling unit mg.Source Transformed Escherichia coli.Form rHBcAg in 9.6 mM phosphate buffered saline, 142 mM NaCl, pH 7.4Purification Purified by ultracentrifugation.Purity 1. A major high molecular weight peak is obtained by gel filtration through Superose 6. Some minor peaks of low molecular weight can be observed. 2. SDS-PAGE under reducing conditions reveals a main 23 kDa band and several other bands. 3. A major band at about 23 kDa and a minor band at 40 kDa were detected by Western blot using IgG from rabbit immunized with HBcAg from liver of HBV infected chimpanzee (done initially when the protocol was established). 4. Round particles of about 30 nm in diameter were detected using immunoelectron microscopy with human anti-HBc (done initially when the protocol was established).Protein concentration 0.2-1.0 mg/ml (Lowry method).Preservative No preservative added.

Selling unit mg.Source Transformed Escherichia coli.Buffer used Acetate buffered 0.4 M NaCl, pH 5.5.Purification Ion exchange chromatography.Protein concentration 0.5-2.0 mg/ml (A280).Preservative No preservative added.

Specifications

Specifications



Hepatitis C VirusRecombinant HCV NS3 Polypeptide mg/custom size* 3000-5104 -70 ºC**


Selling unit mg.Source Transformed Escherichia coli.Buffer used Tris-HCl buffered saline pH 8.6.Purification Affinity chromatography.Protein concentration 0.5-2.0 mg/ml (A280).Preservative No preservative added.

Selling unit mg.Source Transformed Escherichia coli.Buffer used 40 mM Tris-HCl, 200 mM NaCl, pH 8.0.Purification Affinity chromatography.Protein contentration 2-5 mg/ml (Bradford method)Preservative No preservative added.

Selling unit mg.Source Transformed Escherichia coli.Buffer used 50 mM Tris-HCl, 300 mM NaCl, PH 8.0.Purification Ion exchange and affinity chromatography.Protein contentration 8-12 mg/ml (A280 x 0.78).Preservative No preservative added.

Selling unit mg.Source Transformed Escherichia coli.Buffer used 50 mM Tris-HCl, 300 mM NaCl, pH 8.0.Purification Affinity chromatography.Protein contentration 3 - 7 mg/ml (A280 x 0.74).Preservative No preservative added.

Specifications

Specifications

Specifications

Specifications

Treponema pallidumRecombinant p15 Treponema pallidum Ag mg/custom size* 3000-5245 -70 ºC**


Recombinant p17 Treponema pallidum Ag mg/custom size* 3000-5280 -70 ºC**

Recombinant p15 (II) Treponema pallidum Ag mg/custom size* 3000-5289 -70 ºC**



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Treponema pallidumRecombinant p47 Treponema pallidum Ag mg/custom size* 3000-5284 -70 ºC**

Recombinant H-p47 Treponema pallidum Ag mg/custom size* 3000-5263 -70 ºC**

Recombinant H-p17 Treponema pallidum Ag mg/custom size* 3000-5254 -70 ºC**




Selling unit mg.Source Transformed Escherichia coli.Buffer used 50 mM Tris-HCl, 300 mM NaCl, pH 8.0.Purification Affinity chromatography.Protein contentration 4-6 mg/ml (A280 x 0.8).Preservative No preservative added.

Selling unit mg.Source Transformed Escherichia coli.Buffer used 50 mM Tris-HCl, 300 mM NaCl, pH 8.0.Purification Metal affinity chromatography.Protein contentration 2-5 mg/ml (A280 x 0.91).Preservative No preservative added.

Selling unit mg.Source Transformed Escherichia coli.Buffer used 10 mM Tris-HCl, 300 mM NaCl, pH 8.0.Purification Metal affinity chromatography.Protein contentration 2-5 mg/ml (A280 x 1.38).Preservative No preservative added.

Specifications

Specifications

Specifications


Herpes Simplex-1 VirusRecombinant gG1 Protein HSV-1# 0.5 mg/vial 3000-5288 -70 ºC**

Recombinant gG1 Protein HSV-1# mg/custom size* 3000-5279 -70 ºC**

* Packaging available upon request - minimum size 5 mg/vial. ** Avoid repeated freezing and thawing. # This product is manufactured using IBES® technology licensed by ALGENEX S.L.

Selling unit mg.Source Baculovirus infected Trichoplusia ni.Buffer used 10 mM HEPES, 50 mM NaCl, pH 7.5.Purification Ion exchange and affinity chromatography.Protein concentration 0.5-2 mg/ml (subindex x 6.95).Preservative No preservative added.

Specifications


Rubella VirusRecombinant Rubella E1 Antigen 50 mg/custom size* 3000-5261 -70 ºC**

Recombinant Rubella E2 Antigen 50 mg/custom size* 3000-5262 -70 ºC**

* Packaging available upon request - minimum order 50 mg and minimum size 5 mg/vial. ** Avoid repeated freezing and thawing.


Selling unit mg.Source Transformed Escherichia coli.Buffer used Tris buffered saline pH 8.5.Purification Affinity chromatography.Protein concentration 1-3 mg/ml (A280 x 0.57).Preservative No preservative added.

Selling unit mg.Source Transformed Escherichia coli.Buffer used Tris buffered saline pH 8.5.Purification Affinity chromatography.Protein concentration 1-3 mg/ml (A280 x 0.71).Preservative No preservative added.

Specifications

Specifications



Herpes Simplex-2 VirusRecombinant gG2 Protein HSV-2# 0.5 mg/vial 3000-5282 -70 ºC**

Recombinant gG2 Protein HSV-2# mg/custom size* 3000-5283 -70 ºC**

* Packaging available upon request - minimum size 5 mg/vial.** Avoid repeated freezing and thawing. # This product is manufactured using IBES® technology licensed by ALGENEX S.L.

* Packaging available upon request - minimum size 5 mg/vial.** Avoid repeated freezing and thawing.



Selling unit mg.Source Baculovirus infected Trichoplusia ni.Buffer used 50 mM HEPES, 500 mM NaCl, pH 8.2.Purification Ion exchange and affinity chromatography.Protein contentration 0.8-1.5 mg/ml (A280 x 5.45).Preservative No preservative added.

Specifications

Streptolysin-ORecombinant Streptolysin-O mg/custom size* 3000-5258 -70 ºC**

Recombinant Streptolysin-O stabilized mg/custom size* 3000-5259 -70 ºC**

Trypanosoma cruzyRecombinant TcF Chagas Ag 1 mg/vial 3000-5290 -70 ºC**

Recombinant TcF Chagas Ag mg/custom size* 3000-5291 -70 ºC**

Selling unit mg.Source Transformed Escherichia coli.Buffer used Tris-HCl buffered saline pH 8.2.Purification Metal affinity chromatography.Protein concentration 1-2 mg/ml (Lowry method).Total antigenic activity (internal indirect method) > 2500 IU/ml.Specific antigenic activity > 1250 IU/mg of protein.Preservative < 0.1% sodium azide.

Selling unit mg.Source Transformed Escherichia coli.Buffer used 10 mM Tris-HCl, 300 mM NaCl, pH 8.0.Purification Metal affinity chromatography.Protein concentration 1 - 4 mg/ml (BCA method).Preservative No preservative added.

Selling unit mg.Source Transformed Escherichia coli.Buffer used Tris-HCl buffered saline pH 8.5.Purification Metal affinity chromatography.Protein concentration 2-4 mg/ml (A280 x 0.79).Total antigenic activity (internal indirect method) > 4000 IU/ml.Specific antigenic activity > 1500 IU/mg of protein.Preservative No preservative added.

Specifications

Specifications

Specifications

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Polyclonal AntibodiesProduct Description Presentation Reference Storage Page

Anti-HBs Rabbit IgG pAb 5 mg/vial 3000-5505 - 20 º C 20

Anti-HBs Rabbit IgG pAb mg/custom size 3000-5506 - 20 º C 20

Anti-HBs Goat IgG pAb 5 mg/vial 3000-5501 2 - 8 º C 20

Anti-HBs Goat IgG pAb mg/custom size 3000-5502 2 - 8 º C 20

Anti-HBs Guinea Pig IgG pAb 5 mg/vial 3000-5264 2 - 8 º C 20

Anti-HBs Guinea Pig IgG pAb mg/custom size 3000-5265 2 - 8 º C 20

Anti-rHBc Rabbit IgG pAb 5 mg/vial 3000-5527 - 20 º C 21

Anti-rHBc Rabbit IgG pAb mg/custom size 3000-5528 - 20 º C 21

Anti-Treponema pallidum Rabbit IgG pAb 5 mL/vial 3000-5529 - 20 º C 21

Anti-Streptolysin O Rabbit IgG pAb 5 mL/vial 3000-5000 - 20 º C 21

Anti-Rotavirus Rabbit IgG pAb 5 mg/vial 3000-5525 - 20 º C 22

Anti-Rotavirus Rabbit IgG pAb mg/custom size 3000-5526 - 20 º C 22

Anti-C Reactive Protein Rabbit IgG pAb 5 mg/vial 3000-5530 - 20 º C 22

Anti-C Reactive Protein Rabbit IgG pAb mg/custom size 3000-5531 - 20 º C 22


Polyclonal AntibodiesProduct Description Presentation Reference Storage

Hepatitis B VirusAnti-HBs Rabbit IgG pAb 5 mg/vial 3000-5505 -20 ºC**

Anti-HBs Rabbit IgG pAb mg/custom size* 3000-5506 -20 ºC**

Anti-HBs Goat IgG pAb 5 mg/vial 3000-5501 2 - 8 º C

Anti-HBs Goat IgG pAb mg/custom size* 3000-5502 2 - 8 º C


* For large quantities, packaging available upon request - minimum size 10 mg/vial.

Anti-HBs Guinea Pig IgG pAb 5 mg/vial 3000-5264 2 - 8 º C

Anti-HBs Guinea Pig IgG pAb mg/custom size* 3000-5265 2 - 8 º C

* For large quantities, packaging available upon request - minimum size 10 mg/vial.

Selling unit mg.Source Serum of rabbits hyperimmunized with highly purified nHBsAg (ad + ay).Purification Immunoaffinity chromatography.Purity SDS-PAGE, under reducing conditions, shows two major bands at 25 and 50 kDa.Specificity Reacts with all “a” subtypes.Protein concentration 1-4 mg/ml (A280 x 0.71).Preservative < 0.1% sodium azide.

Selling unit mg.Source Serum of goats hyperimmunized with highly purified nHBsAg (ad + ay).Purification Immunoaffinity chromatography.Purity SDS-PAGE, under reducing conditions, shows two major bands at 25 and 50 kDa.Specificity Reacts with all “a” subtypes.Protein concentration 1-3 mg/ml (A280 x 0.71).Preservative No preservative added.

Selling unit mg.Source Serum of guinea pigs hyperimmunized with highly purified nHBsAg (ad + ay).Purification Immunoaffinity chromatography.Purity SDS-PAGE, under non-reducing conditions, shows one major band at approximately 150 kDa.Specificity Reacts with all “a” subtypes.Protein concentration 0.5-2.0 mg/ml (A280 x 0.78).Preservative < 0.1% sodium azide.

Specifications

Specifications

Specifications



Hepatitis B VirusAnti-rHBc Rabbit IgG pAb 5 mg/vial 3000-5527 -20 ºC**

Anti-rHBc Rabbit IgG pAb mg/custom size* 3000-5528 -20 ºC**

Selling unit mg.Source Serum of rabbits hyperimmunized with rHBcAg.Purification Ammonium sulphate precipitation followed by ion exchange chromatography.Purity SDS-PAGE, under reducing conditions, shows two major bands at 25 and 50 kDa.Protein concentration 5-15 mg/ml (A280 x 0.71).Preservative 0.05% chloretone.

Selling unit mL.Source Serum of rabbits hyperimmunized with Treponema pallidum.Purification Ammonium sulphate precipitation.Titer using RPR antigen ≥1:64 dilution.Preservative < 0.1% sodium azide.

Specifications

Specifications

Treponema pallidumAnti-Treponema pallidum Rabbit IgG pAb 5 mL/vial 3000-5529 -20 ºC*

* Avoid repeated freezing and thawing.

Streptolysin-OAnti-Streptolysin O Rabbit IgG pAb 5 mL/vial 3000-5000 -20 ºC*

* Avoid repeated freezing and thawing.

Selling unit mL.Source Serum of rabbits hyperimmunized with purified Streptolysin O.Purification Ammonium sulphate precipitation.Titer using a latex reagent of 200 IU/ml of anti-streptolysin O detection ≥1:16 dilution.Preservative < 0.1% sodium azide.

Specifications



Polyclonal AntibodiesProduct Description Presentation Reference Storage

RotavirusAnti-Rotavirus Rabbit IgG pAb 5 mg/vial 3000-5525 -20 ºC**

Anti-Rotavirus Rabbit IgG pAb mg/custom size* 3000-5526 -20 ºC**

C-Reactive ProteinAnti-C-Reactive Protein Rabbit IgG pAb 5 mg/vial 3000-5530 -20 ºC**

Anti-C-Reactive Protein Rabbit IgG pAb mg/custom size* 3000-5531 -20 ºC**



Selling unit mg.Source Serum of rabbits hyperimmunized with purified Rotavirus.Purification Ammonium sulphate precipitation followed by ion exchange chromatography.Purity SDS-PAGE, under reducing conditions, shows two major bands at 25 and 50 kDa.Protein concentration 5-15 mg/ml (A280 x 0.71).Preservative 0.05% chloretone.

Selling unit mg.Source Serum of rabbits hyperimmunized with purified human C-reactive protein.Purification Ammonium sulphate precipitation followed by ion exchange chromatography.Purity SDS-PAGE, under reducing conditions, shows two major bands at 25 and 50 kDa.Protein concentration 5-15 mg/ml (A280 x 0.71).Preservative 0.05% chloretone.

Specifications

Specifications


Monoclonal AntibodiesProduct Description Presentation Reference Storage Page

Anti-HBs mAb (1DE2) 50 mg/custom size 3000-5012 - 70 º C 24

Anti-Adenovirus mAb (2/6) 50 mg/custom size 3000-5113 - 70 º C 24

Anti-Adenovirus mAb (20/11) 50 mg/custom size 3000-5114 - 70 º C 24


Monoclonal AntibodiesProduct Description Presentation Reference Storage

Hepatitis B VirusAnti-HBs mAb (1DE2) 50 mg/custom size* 3000-5012 -70 ºC**

AdenovirusAnti-Adenovirus mAb (2/6) 50 mg/custom size* 3000-5113 -70 ºC**

Anti-Adenovirus mAb (20/11) 50 mg/custom size* 3000-5114 -70 ºC**




Selling unit mg.Clone No. 1DE2.Immunogen source Hepatitis B surface antigen purified from human plasma. Specificity This antibody specifically recognizes Hepatitis B surface antigen, ad and ay subtypes.Antibody source IN VITRO cell culture.Purification Affinity chromatography.Buffer used Citrate 0.1 M pH 5.0 corrected to pH 7.5.Purity ≥ 95% by SDS-PAGE.Antibody isotype Mouse IgG1 kappa.Protein concentration 2-6 mg/ml (A280 x 0.71).Preservative No preservative added.

Selling unit mg.Clone No. ADV 2/6.Immunogen source Adenovirus 3 infected supernatant culture.Specificity Reacts with all 41 serotypes of Adenoviruses.Antibody source IN VITRO cell culture.Purification Affinity chromatography.Buffer used Citrate 0.1 M pH 5.0 corrected to pH 7.5.Purity ≥ 95% by SDS-PAGE.Antibody isotype Mouse IgG1 kappa.Protein concentration 1-4 mg/ml (A280 x 0.71).Preservative No preservative added.

Selling unit mg.Clone No. ADV 20/11.Immunogen source Adenovirus 3 infected supernatant culture.Specificity Reacts with all 41 serotypes of Adenoviruses.Antibody source IN VITRO cell culture.Purification Affinity chromatography.Buffer used Citrate 0.1 M pH 5.0 corrected to pH 7.5.Purity ≥ 95% by SDS-PAGE.Antibody isotype Mouse IgG1 kappa.Protein concentration 1-4 mg/ml (A280 x 0.71).Preservative No preservative added.

Specifications

Specifications

Specifications


SeraProduct Description Presentation Reference Storage Page

Anti-HBs Goat Serum 5 mL/vial 3000-5097 - 20 ºC 26

Anti-HBs Rabbit Serum 5 mL/vial 3000-5098 - 20 ºC 26

Anti-Treponema pallidum Rabbit Serum 5 mL/vial 3000-5239 - 20 ºC 26

Anti-Rotavirus Rabbit Serum 5 mL/vial 3000-5096 - 20 ºC 26


SeraProduct Description Presentation Reference Storage

Hepatitis B VirusAnti-HBs Goat Serum 5 mL/vial* 3000-5097 - 20 ºC**

Anti-HBs Rabbit Serum 5 mL/vial* 3000-5098 - 20 ºC**

* Packaging available upon request - minimum size 5 ml/vial. ** Avoid repeated freezing and thawing.


Selling unit mL.Source Serum of goat hyperimmunized with highly purified nHBsAg (ad +ay).Preservative < 0.1% sodium azide.

Selling unit mL.Source Serum of rabbits hyperimmunized with highly purified nHBsAg (ad +ay). Preservative < 0.1% sodium azide.

Specifications

Specifications

Treponema pallidumAnti-Treponema pallidum Rabbit Serum 5 mL/vial* 3000-5239 - 20 ºC**

RotavirusAnti-Rotavirus Rabbit Serum 5 mL/vial* 3000-5096 - 20 ºC**



Selling unit mL.Source Serum of rabbits hyperimmunized with Treponema pallidum.Preservative < 0.1% sodium azide.

Selling unit mL.Source Serum of rabbits hyperimmunized with purified Rotavirus.Preservative < 0.1% sodium azide.

Specifications

Specifications


Under DevelopmentNative Antigens

Helicobacter pylori Antigen

Recombinant Antigens

Recombinant Trypanosoma cruzi FP3 Antigen



Can Malé 08186 Lliçà d’Amunt Barcelona, Spain Phone: +34-93-860-9000 www.biokit.com 31

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Living Immunoassay Excellence.

Biokit is a biotechnological company aimed at the research, development, manufacture and worldwide distribution of clinicaldiagnostic reagents and systems.

Biokit’s mission is to become the partner of choice as a Centre of Excellence for Immunoassay by providing innovative OEM solutions (products & services) to major IVD players.

Biokit is strongly founded on three major values:

Innovation at all the company levels, always focused on science and technological advances to ensure that our portfolio continuously improves and evolves.

Quality in all processes, from the conception of and research on a new product, up to its final manufacturing and marketing.

Commitment to patients and healthcare professionals, improving quality of care and facilitating disease diagnosis.

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